Nonsurgical Treatments for Urinary Incontinence in Adult Women

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Aksac, 2003478 50 postmenopausal Not reported Pelvic floor muscle Usual care, hormone Country: Turkey women with female exercise replacement therapy Aim: the effects of urinary stress (contractions for 10 pelvic floor muscle incontinence taking seconds and exercises or HRT relaxation for 20 biofeedback on seconds, 10 female urinary times/session, 3 stress incontinence sessions/day) via digital palpation at home; pelvic floor muscle exercise (contractions for 10 seconds and relaxation for 20 seconds) via biofeedback Alewijnse, 2003479 129 community- Continence, Bladder training Bladder training and Country: The dwelling women neurological conditions, with voiding pelvic floor muscle Netherlands over 17 years old venereal disease, viral frequency of ~7 exercise Aim: the with urinary infections, using voidings/day and effectiveness of incontinence, ability medication that may pelvic floor muscle pelvic muscle floor to complete impact incontinence, exercise: 10 slow exercise therapy questionnaires in pregnancy or 3 months twitch contractions supplemented with Dutch language. after delivery, after (10-30 seconds) a health education surgical treatment for and 10 fast twitch program urinary incontinence, and contractions (2-3 incontinence among women with physical seconds), 5 women. impairments. Severe times/day, each prolapse contraction being followed by relaxation Amaro, 2005480 40 women with Anticholinergic and Intravaginal Sham stimulation Country: Brazil mixed urinary tricyclic antidepressant electrical with inactive device Aim: the effect of incontinence and medications, pelvic stimulation with 3 intravaginal predominant urge floor exercise, bladder 20-minute electrical incontinence. training, vaginal sessions/week stimulation on prolapse more than II using 4Hz pelvic floor muscle grade, urinary tract frequency. strength in women infection, metal with mixed urinary implants, and incontinence. neurological diseases

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Amaro, 2006481 40 women Use of pelvic floor Effective Sham intravaginal Country: Brazil symptoms of exercises or bladder intravaginal electrical stimulation Aim: the effects of predominant urge training, vaginal electrical using frequency of intravaginal incontinence not prolapse >grade II, stimulation using 4Hz with 3 20-minute electrical taking retention complaint or frequency of 4 Hz sessions/week stimulation in mixed anticholinergics or obstruction diagnosis with 3 20-minute urinary incontinence tricyclic during UDS, urinary sessions/week antidepressants infection, changes in cutaneous sensitivity, metal implants, and neurological diseases. Andersen, 2002482 Adult women 21 Urge primary Durasphere 4.5 mL Contigen 4.2 mL Country: USA years of age or incontinence, injected injected Aim: the long-term older with stress UI uncontrolled bladder submucosally submucosally effectiveness of caused by intrinsic instability, positive urine between the between the bladder Durasphere vs. sphincter deficiency culture, previous bladder neck and neck and external Contigen in the for a period of at urethral bulking external sphincter sphincter treatment of female least 12 months; treatments, medication stress urinary positive pad weight affecting the evaluation incontinence test; failure of of incontinence, caused by intrinsic previous non pregnancy sphincter deficiency invasive treatments, post void residual <100 mL and abdominal leak point pressure Appell, 2006483 173 women with Evidence of detrusor Transurethral Sham treatment Country: USA stress urinary overactivity on radiofrequency probes lacked needle Aim: the effects of incontinence, cystometrogram, post- energy collagen electrodes and sham transurethral bladder outlet void residual bladder micro-remodeling treatment of radiofrequency hypermobility, and volumes >50cc, radiofrequency energy collagen leak point pressure significant pelvic organ generator micro-remodeling >60cm/H2O prolapse (POP-Q Stage on female stress IV) on physical urinary incontinence examination, history of dry or wet overactive bladder, previous surgical or bulking agent therapy Arvonen, 2001484 37 women ages 25- Pregnancy, Pelvic floor muscle Pelvic floor muscle Country: Sweden 65 with stress cysto/rectocele, training program training program with Aim: the effects of urinary prolapse, urinary tract with contractions/ contractions/ pelvic floor muscle incontinence, infection, altered relaxations for 5 relaxations for 20/20 training with and understanding of vaginal tissue, and seconds 10 times seconds 10 times without vaginal balls spoken Swedish medication affecting the twice a day twice a day using on females stress functioning of the weighted vaginal urinary incontinence urinary tract or kidneys balls 50-100g.

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Aukee, 2002485 30 women with Genital protrusion Pelvic floor muscle Pelvic floor muscle Country: Finland urodynamically beyond the vaginal exercise after exercise after verbal Aim: the effec tested stress hymen, an inability to verbal and written and written ts of incontinence ages understand instructions instructions for instructions for home electromyography- 31 to 69 years for home training, home practice of 20 practice of 20 assisted without previous pregnancy, and any minutes/day 5 minutes/day 5 times biofeedback training incontinence severe disease such as times/week and per week and pelvic floor operations and an malignancy in the individual EMG- muscle training on abdominal leak abdominal region, assisted female stress point pressure >90 multiple sclerosis, and biofeedback device urinary incontinence insulin-dependent with vaginal probe diabetes and verbal control Aukee, 2004486 35 women 21-70 Previous incontinence 1. Home program Home program with Country: Finland years old with operations, genital with given verbal given verbal and Aim: the urodynamically prolapse, inability to and written written instructions effectiveness of confirmed stress understand instructions instructions for for home practice pelvic floor training incontinent for home training, home practice and with home (maximal urethral pregnancy, severe advise to practice biofeedback device closure pressure diseases such as for 20 minutes/day, among women with >20cm/H2O and malignancies in the 5 times/week. stress urinary cough leak point abdominal region, 2. Pelvic floor incontinence pressure multiple sclerosis and training by >90cm/H2O) diabetes mellitus physiotherapist 5 requiring insulin times/12 weeks: 3-5 second contractions with 10 second intervals in supine Bano, 2005487 50 women with Not reported Peri or transurethral Transurethral silicone Country: UK urodynamically porcine dermal injection Aim: the effects of proven stress implant injection (Macroplastique) porcine dermal incontinence (Permacol) implant (Permacol) and silicone injection (Macroplastique) on urodynamic stress incontinence in females Barroso, 2004488 36 women (24 Prolapse or first degree Transvaginal Placebo Country: Brazil patients and 12 urogenital prolapse, electrical Aim: the effects of controls) with intrinsic sphincter stimulation at home transvaginal stress, urge, or deficiency, cardiac twice a day (20- electrical mixed urinary pacemaker; pregnancy, minute sessions) stimulation on incontinence postmenopausal with frequency of 20 urinary incontinence climacteric with (urge) or 50Hz symptoms and signs of (stress UI), a pulse urogenital atrophy (they width of 300ms, could be included after with asymmetrical 3 months of treatment biphasic pulses, an with hormone- adjustable current replacement therapy intensity (0-100mA)

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Blowman, 1991491 Only patients Not reported Neurotrophic Placebo stimulation Country: UK diagnosed from stimulation Aim: To assess the bladder pressure efficacy of studies as suffering neuromuscular from genuine stress stimulation and incontinence were pelvic floor recruited. They all exercises, had maximum compared with bladder volumes pelvic floor over 500ml and exercises only, in exhibited no the treatment of detrusor contraction genuine stress in lying or standing. incontinence All patients demonstrated cough-induced leakage when standing. They were referred to the physiotherapy department gynecology unit and gave informed written consent to take part in the trial. Bo, 1997492 12 women with Not reported 3 voluntary PFM Electrical stimulation Country: Norway genuine stress contractions and 2 with Medicon 50 Hz - Aim: Crossover incontinence electrical pulse width 0.5ms, 0- RCT to examine the participated in stimulators Conmax 100mA effect of voluntary pelvic floor exercise 50Hz – pulse width pelvic floor muscle program with 8-12 0.75ms, 0-90mA contraction and contractions Medicon 50Hz - vaginal electrical pulse width 0.5ms, stimulation on 0-100mA urethral pressure in women with genuine stress incontinence

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Borawski, 2007496 30 women >55 Not reported Electrical Electrical stimulation Country: USA years with stimulation with with surgical first Aim: the effects of refractory urge percutaneous stage lead placement percutaneous incontinence after needle electrode needle electrode failure of medical, (22-G spinal technique or a behavioral, and needle) placement surgical first stage pelvic floor lead placement on reeducation implantation of a management pulse generator in older urge incontinent women Borello-France, 44 women 38 to 70 Pregnancy, symptoms Pelvic floor muscle Pelvic floor muscle 2006497 years old, of urgency or urge exercises with EMG exercises with EMG Country: USA ambulatory, with urinary incontinence, biofeedback in the biofeedback in both Aim: the effects of symptoms of stress prior treatments for supine position only supine and upright exercise position urinary incontinence stress urinary using maximum 30- positions, during pelvic-floor >1/week incontinence (collagen 60 repetitions of 3- 1 set (3- and 12- muscle exercises injection, medications 12 second second contractions) on females stress affecting bladder tone, contractions twice in each position with urinary incontinence pessary, or surgery), daily maximum 20 practicing pelvic-floor repetitions (2 sets of muscle exercises, 10) of the 3-12 pacemaker, use of second contractions intrauterine device, twice daily medical history of pelvic cancer, severe endometriosis, neurologic or metabolic disorders likely to impair bladder or sphincter function Borello-France, Women 38 to 70 A medical history that High-frequency (4 Low-frequency (1 2008498 years of age, not included pelvic cancer, times per week) time/week) Country: USA pregnant, severe endometriosis, maintenance 2 maintenance 2 Aim: comparative ambulatory, and use of an intrauterine times/day exercise times/day exercise effectiveness of recorded at least device, or pacemaker; program with 60 program with 60 maintenance one SUI episode neurologic or metabolic repetitions (3 sets repetitions (3 sets of exercise program and no urgency or disorders associated of 20 repetitions) of 20 repetitions) of a 3- either 1 or 4 times urge urinary with bladder or a 3-second PFM second PFM per week in women incontinence (UUI) sphincter dysfunction; contraction and 30 contraction and 30 with stress UI in a 7-day bladder previous repetitions (3 sets repetitions (3 sets of diary medical/surgical of 10 repetitions) of 10 repetitions) of a treatments for SUI; or a 12-second 12-second prior in contraction per contraction per exercise session exercise

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Borrie, 2002499 421 subjects 26 Pregnancy, residency Lifestyle Usual care Country: Canada years of age or of long-term care modification Aim: the effects of older with self institutions, dementia sessions every 4 combined lifestyle reported urinary weeks led by and behavioral incontinence at trained “nurse interventions led by least once per continence nurses in the week, resided in the advisers” with a management of community, and physician with urinary incontinence communicated in expertise in English continence management Bower, 1998500 48 women with Urinary tract infection, Active 1. Sham Country: Australia proved detrusor pregnancy, cardiac transcutaneous transcutaneous Aim: the effects of instability or pacemaker, impaired electrical nerve electrical nerve surface sensory urgency cognition, neurogenic stimulation with stimulation with neuromodulation on bladder dysfunction or 10Hz. frequency sacral or suprapubic cystometric cystocele beyond the and 200 placement pressure and introitus microsecond pulse 2. Active volume parameters width (sacral transcutaneous in women with placement) electrical nerve detrusor instability stimulation with or sensory urgency. 150Hz. frequency and 200 microsecond pulse with (suprapubic placement) Boyington, 2005501 Women 50 years or Toilet dependently; computer-based Alternate computer- Country: USA older who lived blood in their urine, system to promote based system Aim: the effects of independently in the recurrent urinary tract continence health simulating women’s computer-based community with infections, persistent using health clinic magazine with system for symptoms of UI, difficulty with bladder visit metaphor that information about continence health urinary frequency or emptying as evidenced provided fact breast self- promotion that urgency, or by straining or other sheets, testimonials examination and tips included self- nocturia; minimum efforts to drain the from women who for women traveling management of 30 on the bladder completely, or improved with the alone techniques for Telephone symptomatic pelvic adoption of women with Interview for prolapse behavioral symptoms of Cognitive Status- techniques; the involuntary urine modified (TICS-m); expert system loss, urinary Self-reported ability advice on Bladder frequency or to read and write E training, PFMT, fluid urgency, or nocturia man Brown, 2006502 2,191 women in the Exclusion criteria: Intensive lifestyle Placebo twice daily. Country: USA Diabetes Taking medications that therapy to lose and Aim: the effects of Prevention Program could affect glucose maintain at least intensive lifestyle RCT older than 25 tolerance or serious 7% of initial body intervention or years, body mass medical illness weight through a metformin on index ≥24kg/m2, a low-fat diet and to prevalence of fasting plasma engage in urinary incontinence glucose level 95- moderate-intensity among overweight 125mg/dl, and a 2- physical activity for pre-diabetic women hour post-challenge at least 150 minutes glucose level 140- each week 199mg/dl

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Brubaker, 1997503 121 women >25 Urinary incontinence The transvaginal Sham inactive device Country: USA years of age with other than genuine electric stimulation Aim: the effects of either urinary stress incontinence, for 20 minutes 2 transvaginal incontinence due to detrusor instability, or times/day using electrical detrusor instability mixed incontinence; frequency of 20Hz, stimulation for or genuine stress leakage episodes a 2-second-4- treatment of urinary incontinence, or <3/week, inadequate second work-rest incontinence in both (mixed genitourinary estrogen cycle with a range women incontinence) (minimum 3 months of stimulation diagnosed with HRT), inadequate intensities, from 0- filling cognitive ability 100mA urethrocystometry (investigator judgment), urinary tract infection, anatomic defect that precluded use of device, postvoid residual >100ml, implanted electric device, genitourinary surgery, drug treatment for urinary incontinence, anticipated geographic relocation during study. Bryant, 2002504 95 consecutive Cognitive impairment, Education to reduce Bladder training: Country: Australia adult patients with pregnancy, urinary tract caffeine intake to increasing intervals Aim: the effects of urinary symptoms infection <100mg/day plus between voiding; caffeine restriction with routine intake bladder training increasing fluid intake on urinary of caffeine >100mg to 2 L/day; urinary incontinence every 24 hours deferment symptoms techniques; ceasing “just in case” voiding Burgio, 2002505 222 ambulatory, Continual leakage, Biofeedback- Self-administered Country: USA nondemented, postvoid residual urine assisted behavioral behavioral treatment Aim: the effects of community-dwelling volume >150ml, severe training using a self-help biofeedback as a women ages 55 to uterine prolapse past implemented by booklet to advise part of complex 92 years with urge the vaginal introitus, nurse practitioners. pelvic floor exercise behavioral training incontinence or decompensated Abdominal pressure and bladder control program for urge mixed incontinence congestive heart failure, and sphincter incontinence in >2 times/week for or impaired mental responses were community-dwelling at least 3 months, status (Mini-Mental measured with 3- older women and with State Examination baloon probe urodynamic score <24) inserted in rectum. evidence of bladder Pelvic floor muscle dysfunction exercise with 10 (detrusor instability second during filling or contractions/10 provocation or second relaxation maximal for 20-30 minutes cystometric capacity of ≤400ml)

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study de Oliveira Women with Detrusor overactivity, Pelvic floor Individual pelvic floor Camargo, 2009510 confirmed chronic neurological or exercises in a group exercises Following Country: Brazil urodynamic SUI, muscular diseases, with two weekly PERFECT Aim: comparative positive cough abnormal genital sessions of 45 assessment scheme effectiveness of stress test, and less bleeding, uterine minutes each. In with contractions in individual vs. group than 3 g of leakage prolapse, advanced the orthostatic accordance with the pelvic floor muscle as measured by a genital prolapse, active position, patients endurance, power, training pad test with a genitourinary tract received oral and time that the standardized infections, pregnancy, instructions to patients could bladder volume or vaginal atrophy, perform ten tolerate. (200 ml) intrinsic sphincter contractions of 5 deficiencies, Valsalva seconds with 5 leak seconds of recovery time, 20 contractions of 1 second with 1 second of recovery time Cammu, 1998511 60 ambulatory and Not in abstract Weekly session of Vaginal weight cones Country: Belgium fit white women with pelvic floor (20, 32, 45, 57, and Aim: the effects of urodynamic urinary exercises vaginal 70 g) for 15 minutes, pelvic floor stress incontinence, probe-EMG twice daily exercises and and vaginal biofeedback using vaginal weight capacity permitting perineometer cones in the the use of a vaginal treatment on female probe-EMG genuine stress biofeedback-or incontinence cones post-partum period, and had neither a genital prolapse nor any other associated pathology

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Coleman, Frail older adults Severe illness that New model of Usual care Country: USA were those precluded their primary care, Aim: the effect of enrollees at high participation in the Chronic Care Chronic Care risk for study; moderate to Clinics: Clinics on urinary hospitalization severe dementia; (1) An extended (30 incontinence in frail according to the residence in a nursing minutes) visit to the older adults Chronic Disease home, terminal illness patient’s physician Score, the patients and team nurse in the Group Health dedicated to Cooperative of developing a Puget Sound, a shared treatment large Health plan that Maintenance emphasized the Organization reduction of located in western disability; Washington State (2) A session with the pharmacist Corcos, 2005513 133 women older Contraindications to Intraurethral Surgery (needle Country: Canada than 30 years with surgery or collagen collagen bladder neck Aim: Noninferiority stress urinary injections (allergic submucosal suspensions, Burch, RCT to examine incontinence lasted reaction), associated injection 4 injections and slings). The effects of collagen for >6 months conditions (e.g., severe at 1-month intervals choice of technique injection or surgery medical disease or was left to the on female stress indication for surgeon urinary incontinence hysterectomy) or pelvic prolapse (vault, cystocele, rectocele), neurogenic bladder or interstitial cystitis Demain, 2001514 Women over 18 Pregnancy, recent Three educational One 45-minute Country: USA years of age with pelvic surgery (3 group sessions with individual treatment, Aim: comparative clinical symptoms of months), history of 4-12 women. instructions in pelvic effectiveness of stress and/or urge pelvic malignancy, fecal Women attended 3 floor muscle exercise group versus incontinence incontinence, current 1-hour sessions individual (median duration of urinary infection, grade with educational management on symptoms 3 years 7 III prolapse, diseases of and exercise physical symptoms months) presenting central nervous system, components and quality of life in to physiotherapy acute mental illness female urinary and dementia, previous incontinence physiotherapy for incontinence Demirturk, 2008515 Women with Urinary tract infections, Interferential current Kegel exercises with Country: Turkey urodynamic stress detrusor over activity, with a frequency of biofeedback 5 Aim: comparative UI and moderate cognitive problems and 0–00 Hz 5 minutes minutes per session, effectiveness of intensity of neoplasm per session, three three times a week interferential current incontinence as times a week for a for a total of 5 and biofeedback determined by a total of 5 sessions sessions applications on one-hour pad test incontinence referred Physical severity in patients Therapy and with urinary stress Rehabilitation, incontinence Women’s Health Unit

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Dumoulin, 2004521 64 premenopausal Current pregnancy, 1. Pelvic floor Relaxation massage Country: Canada women younger urinary incontinence rehabilitation: 15 for the back and Aim: the than 45 years before pregnancy, minute electrical extremities by effectiveness of presenting previous surgery for stimulation of the physiotherapist. They multimodal symptoms of stress stress incontinence, pelvic floor muscle; were asked not to supervised urinary incontinence moderate to severe then 25 minute exercise their pelvic physiotherapy at least once per urogenital prolapse, pelvic floor muscle floor muscles at programs among week 3 months or involuntary detrusor exercise program home. women with more after their last contraction on with biofeedback, persistent postnatal delivery cystometry neurologic which included stress urinary or psychiatric disease, strengthening and incontinence or a major medical motor relearning condition, taking exercises and a medication that could home exercise 5 interfere with their days/week. evaluation or treatment, 2. Pelvic floor inability to understand rehabilitation plus French or English abdominal training: instructions. in addition to PFE Loss of followup: 2, 30 minutes of deep plus 2 did not attend abdominal muscle the final examination training consisting and were excluded of isolation, from the analysis. reeducation, and functional retraining of the transversus abdominis Elser, 1999522 204 women 45 Reversible cause of Patient education, Bladder training Country: USA years or older, incontinence, self-monitoring with Aim: the effects of ambulatory, uncontrolled metabolic treatment logs, pelvic floor muscle mentally intact with conditions (e.g., compliance training, bladder urodynamic diabetes mellitus), assessment, and training, or both, on genuine stress postvoid residual of positive urodynamic incontinence or >100ml, persistent reinforcement parameters in detrusor instability, urinary tract infection, techniques women with urinary with or without urinary tract fistula, or administered by incontinence stress incontinence, indwelling trained research experiencing 1–100 catheterization nurses. Pelvic floor episodes of muscle training incontinence per with10 fast (3 week as recorded second) on the qualifying 7- contractions and 40 day diary sustained (10 second) contractions

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Felicissimo, 2010526 Women with Chronic neurological Supervised Pelvic Unsupervised Pelvic Brazil confirmed muscular diseases, Floor Muscle Floor Muscle Training The effectiveness of urodynamic stress abnormal genital Training intensive urinary incontinence bleeding, genital supervised PFMT to with Valsalva leak prolapse at stage ≥2 of unsupervised PFMT point pressure more POP-Q (Pelvic Organ in the treatment of than 60 cm/h2O Prolapse- female stress UI and no detrusor Questionnaire), active overactivity. All genitourinary tract subjects had infections, pregnancy, predominant and women who symptoms of SUI preferred surgery. with an average of Patients with intrinsic at least three stress sphincter deficiencies continence as identified by episodes per week. Valsalva leak point pressure ≤60cm H2O measured in the sitting position with a volume of 250ml in the bladder were also excluded Finazzi-Agro, Men and women Not reported Posterior tibial Posterior tibial nerve 2005527 with overactive nerve stimulation 3 stimulation 1 Country: Italy bladder syndrome times/week time/week Aim: comparative not responding to effectiveness of antimuscarinic posterior tibial therapy nerve stimulation performed weekly vs. 3 times per week in men and women with overactive bladder syndrome

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Finazzi-Agro, 1) Urge 1) Pregnancy or Percutaneous tibial Placebo 2010528 incontinence and intention to become nerve stimulation Italy urodynamically pregnant during the To evaluate the diagnosed detrusor study; 2) Active urinary efficacy of overactivity tract infection or percutaneous tibial incontinence; 2) recurrent urinary tract nerve stimulation in Unresponsive to infections (more than 4 female patients with behavioral and per year); 3) Presence detrusor overactivity rehabilitation of urinary fistula, incontinence therapy or bladder or kidney antimuscarinic; 3) stones, interstitial Able to give written, cystitis, cystoscopic informed consent; abnormalities that could 4) 18 years of age be malignant; 4) or older; 5) Mentally Diabetes mellitus; and competent and able Cardiac pacemaker or to understand all implanted defibrillator study requirements; 6) Able to understand the procedures, advantages and possible side effects; 7) Willing and able to complete a 3-day voiding diary and I- QoL questionnaire; 8) Bladder capacity 100 ml or greater; 9) No signs of neurologic abnormalities at objective examination; no history of neurologic pathology; and no pharmacological treatment or pharmacological treatment unchanged for 30 days before beginning the study Fujishiro, 2000529 62 women, 37 to 79 Urinary infection, Magnetic Sham stimulation Country: Japan years old with interstitial cystitis and stimulation of sacral with inactive device Aim: the effects of stress incontinence, large uterine myoma, roots with 15Hz. magnetic >1 episode of and other treatments frequency, 50% stimulation of the urinary leakage for stress incontinence, intensity output for sacral roots for the recorded in a 3-day including pelvic floor 5 seconds per treatment of stress voiding diary, and 2 exercises, medical minute for 30 incontinence gm or more urine treatment and electrical minutes loss on a 1-hour stimulation pad test

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Fujishiro, 2002530 37 women 43 to 75 Neurological disorders Magnetic Sham stimulation Country: Japan years old with the suggesting neurogenic stimulation of sacral with inactive device Aim: the effects of complaint of urinary bladder dysfunction, roots with 15Hz. magnetic frequency and/or apparent episode of frequency, 50% stimulation of the urge incontinence, stress incontinence, intensity output for sacral roots for >8 voids daily urinary infection, 5 seconds per treating urinary and/or >1 episode interstitial cystitis or minute for 30 frequency and urge of urge large uterine myoma , minutes incontinence incontinence on a other treatments for 3-day voiding diary, urinary frequency or and mean of less urge incontinence, than 250 ml. urine including pelvic floor volume per void on exercises, medical a 3-day voiding treatment or electrical diary stimulation Gallo, 1997531 Women ages 20–80 Pregnancy and The audiotape 45 minute Country: USA with a history of psychological disorders reinforced pelvic appointment with the Aim: comparative self-reported stress that would make it floor exercise specialized on UI effectiveness of urinary incontinence difficult to follow pelvic instruction with nurse investigator external cue to and objective floor exercise counted aloud 25 with detailed verbal action, an genuine stress instruction consecutive pelvic instructions about audiocassette tape, incontinence during floor muscle pelvic floor muscle to improve pelvic a urodynamic exercise identification and floor muscle evaluation contractions for 10 contraction; proper exercise seconds and then pelvic floor muscle compliance in relaxing for 10 contraction by the women with stress seconds; 45-minute patient measured urinary incontinence appointment with using a biofeedback the specialized on computer UI nurse investigator Gameiro, 2010532 To be eligible, Anterior or posterior Assisted Pelvic Vaginal weight cone Country: Brazil patients had been vaginal prolapse Muscle Floor Aim: To compare referred by a beyond grade II, urinary Training the efficacy of the gynecologist as infection, neurological VWC (Vaginal having symptom of or demyelinating Weight Cone) and predominant SUI, condition, and poor assisted PFMT to and 50% also comprehension. treating UI in presented urge women. incontinence. None of the patients had a urodynamic diagnosis of SUI. None of the patients had taken anticholinergics or tricyclic antidepressants or had been treated using pelvic floor exercises or bladder training.

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Ghoniem, 2009533 Women with a Not viable mucosal Transurethral Transurethral Country: USA, diagnosis of SUI lining, abnormal injection of injection of Contigen® Canada primarily due to ISD bladder capacity, Macroplastique Aim: the that failed behavior urinary tract infection, effectiveness and modification uncontrolled detrusor safety of (biofeedback) or overactivity, high post- Macroplastique® as exercise (Kegel) void residual urine minimally invasive volume, high grade endoscopic pelvic organ prolapse, treatment for female confounding bladder stress urinary pathology, pregnancy incontinence or morbid obesity primarily due to intrinsic sphincter deficiency Gilling, 2009534 Women >20 years Previous incontinence Electromagnetic Sham stimulation Country: New old; symptoms of or pelvic floor surgery, stimulation 3 with a thin deflective Zealand SUI or mixed UI, Grade 3 or 4 pelvic times/week using aluminum plate Aim: the efficacy of genuine SUI prolapse (ICS the NeoControl inserted in the chair, extracorporeal confirmed by pad- classification), chair (Neotonus which prevented electromagnetic testing and pregnancy, drugs, e.g. Inc., Marietta, GA, penetration of the stimulation of the urodynamics, diuretics, alga- USA) with 10- magnetic field into pelvic floor for ambulatory and adrenergic antagonists minute stimulation the patient, and treating female community- or other medication at 10 Hz followed simulated the noise stress urinary dwelling, prescribed for bladder by a 3-minute rest and sensation incontinence neurologically dysfunction, concurrent and then a further produced during normal, agree not to use of internal medical 10-minute active treatment seek or use any device stimulation at 50 sessions. other form of Hz. The intensity treatment for UI was adjusted to the during the study, maximum level otherwise healthy Glavind, 1996535 Women with self Intravesical obstruction Physiotherapy 2-3 physiotherapy 2-3 Country: Denmark reported and detrusor instability, times with individual times Aim: effects of incontinence when previous surgery for instruction with individual biofeedback on coughing, laughing, urinary incontinence combined with instruction alone continence rates in lifting and during biofeedback four women with stress physical exercise times. Biofeedback UI verified by a was performed with positive 1-hour pad- a vaginal surface weighing test (>2 g) electrode (Dantec with a bladder 21L20, Skovlunde, volume of three- Denmark) and a quarters of the rectal catheter. cystometric capacity Glavind, 1997536 Women 44-68 intravesical obstruction half an hour of Half an hour of Country: Denmark years with stress and detrusor instability aerobic exercises aerobic exercises on Aim: the effects of urinary on 2 consecutive 2 consecutive days vaginal sponge incontinence lasting days with the without the vaginal intended to support from 1 to 11 years, vaginal sponge sponge the urethra during with daily episodes intended to support aerobic exercise in of incontinence. the urethra women with stress urinary incontinence

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Goode, 2003294 105 ambulatory, Continual leakage, Four sessions (over Placebo control Country: USA non demented, postvoid residual urine 8 weeks) of condition, usual care Aim: the effect of community-dwelling volume greater than biofeedback- biofeedback- women 55 and 200ml, uterine prolapse assisted behavioral assisted behavioral older with self- past the introitus, training by nurse training on urinary reported urge narrow-angle practitioners incontinence in incontinence at glaucoma, unstable older women least twice per angina pectoralis, week for >3 months congestive heart failure, with urodynamic history of malignant evidence of bladder arrhythmias, or dysfunction impaired mental status Goode, 2003 200 ambulatory, Continual leakage, Behavioral training Control: self- Country: USA nondemented, postvoid residual urine (biofeedback- administered Aim: whether pelvic community-dwelling volume >150ml, severe assisted pelvic floor behavioral training floor electrical women ages 40 to uterine prolapse, muscle training, administered with a stimulation 78 years with congestive heart failure, home exercises, self-help booklet with increases efficacy urinary incontinence hemoglobin A1C ≥9, or bladder control suggestions for of behavioral (at least 2 stress impaired mental status strategies, and self- isolating the pelvic training for incontinence (Mini-Mental State monitoring with floor muscles, community-dwelling episodes per week Examination score <24) bladder diaries). progressive home women with stress on the 2-week Anorectal exercise, self incontinence baseline bladder biofeedback (~20 monitoring, and diary) confirmed minutes) with 3- bladder control during urodynamic balloon probe to strategies testing measure sphincter pressure Gorman,1995537 Ambulatory, alert, Dependence on a 1. The expert General health video Country: USA community dwelling urinary catheter; not system-the Urinary Aim: effectiveness women with urinary successful completion Incontinence of an expert system incontinence of a mental competency Consultation for disseminating defined as test System-with the knowledge to accidental urine Agency for Health women with urinary loss at least twice a Care Policy and incontinence week Research (AHCPR) patient guideline for urinary incontinence and research literature for behavioral treatments 2. The educational printed booklet Hahn, 1991538 Women not Not reported Pelvic floor training Intravaginal electrical Country: Sweden previously operated stimulation Aim: To compare upon, with pure the effect of two stress urinary conservative incontinence, methods and consecutively evaluate the long - referred for surgery term results

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Harvey, 2002539 Consecutive adult Age >65 year, detrusor Biofeedback Weighted vaginal Country: Not clinic patients with overactivity, past cones reported symptoms of mainly treatment with Aim: To determine stress incontinence cones/biofeedback/ the comparative and confirmed electrical effectiveness of urodynamic stress stimulation/surgery, weighted cones incontinence on POPQ >stage 3. versus biofeedback urodynamics were in women with approached urodynamic incontinence Hu, 1989540 143 women with Hospitalization, 13-week behavior Control group Country: USA confirmed stress insufficient number of therapy program for received usual Aim: the effects of incontinence in wet episodes per day urinary incontinence incontinence-related behavior therapy seven nursing (an average 0.18) which included care program for urinary homes with ability hourly checking and incontinence on to recognize her prompting of women residents of own name. individuals to toilet, nursing homes praising for successful toileting, and social reinforcement (additional personal service). Huang, 2009541 The PRIDE study: Any condition that Intensive lifestyle The structured Country: USA at least 30 years would prevent safely and behavior education program: Aim: the effects of old, have a BMI of participating in an change program 1-hour group an intensive 25 to 50 kg/m2 and intensive diet and modeled after the educational sessions behavioral weight self-report at least exercise program Diabetes at months 1, 2, 3, and reduction 10 episodes of without medical Prevention Program 4, providing general intervention on incontinence weekly supervision, medical and Look AHEAD information about sexual function in therapy for (Action for Health in weight loss, physical overweight and incontinence, or weight Diabetes) trials activity, healthy obese women with loss in the previous designed to eating habits and urinary incontinence month produce an average health promotion loss of 7% to 9% of initial body weight weekly 1-hour group sessions led by continent nurse Hui, 2006542 Community- Active urinary tract The nurse specialist Face-to-face Country: China dwelling older infection, a post-void provided behavioral consultation the Aim: the effects of women 60 years or residual volume by training to the group nurse specialist to telemedicine vs. a over, with bladder ultrasound of via give digital conventional symptoms of urge more than 150 ml, third- videoconferencing, assessment feedback outpatient or stress degree uterine prolapse with the support of on pelvic floor continence service incontinence, and and treatment for a female registered contraction + booklet (CS) in community- with one or more urinary symptoms nurse who helped on urge and stress dwelling older incontinence to run the TCP incontinence women with urge or episodes in a week sessions. Each management stress incontinence participant was encouraged to share her experiences with the nurse specialist

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Hung, 2010543 Women aged 18-65 Being pregnant or less Diaphragmatic, Placebo (Self- Country: Taiwan years and had at than three months deep abdominal monitored PFM Aim: To investigate least one episode of postpartum, having and pelvic floor exercises) the effect of treating SUI symptom systemic retraining SUI symptoms in during the previous neuromuscular disease, women by month having had previous retraining surgery or intensive diaphragmatic, PFMT for UI, having deep abdominal severe low back pain or and PFM pelvic pain, having had coordinated a radical hysterectomy function. or having ongoing urinary tract infections Janssen, 2001544 530 women of all Neurological cause of Individual pelvic Group pelvic floor Country: The ages (mean 47.8 incontinence, a tumor floor exercises 5 exercises 5 times/day Netherlands years) with stress, or infection in the times/day and and bladder training Aim: the effects of urge, or mixed pelvis, severe vaginal bladder training with with delay voiding, individual and group incontinence prolapse delay voiding, training with 9 2-hour physiotherapy for training with 11 30- sessions urinary incontinence minute sessions in women Jeyaseelan, 2000545 Women with Neurological conditions The electro Sham electrical Country: UK urodynamically diagnosed by stimulation stimulation consisted Aim: effects of proven stress consultant; Previous technique described of one 250-μs electrical incontinence electrical stimulation for by Oldham impulse every minute stimulation on stress incontinence, (International for 60 minutes women stress prolapse; pregnancy; Patent Publication incontinence pacemakers and WO98/47357) with cardiomyopathy; a background low abnormal frequency (to target urological/gynecological slow twitch fibers) findings; urinary and intermediate tract/vaginal infection; frequency with an recent pelvic floor initial doublet (to surgery target fast twitch fibers). Karademir, 2005323 43 patients with Urinary tract Stoller afferent Stoller afferent Country: Turkey symptoms of obstruction, urinary neurostimulation neurostimulation with Aim: the effects of detrusor overactivity retention, neurologic or with frequency frequency 20Hz and Stoller afferent confirmed metabolic disorder, 20Hz and amplitude amplitude 0.5-10mA neurostimulation urodynamically other treatments for 0.5-10mA combined with 5mg with and without a urinary incontinence of oral oxybutynin low-dose hydrochloride anticholinergic (oxybutynin hydrochloride) in patients with detrusor overactivity

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Kim, 2009, 546 Women aged 70 Not reported Exercise treatment Placebo Country: Japan and older who enhancing PFM and Aim: To determine reported urine functional fitness the effects of leakage one or exercise treatment more times per on reducing urine month. leakage in Japanese elderly women with stress, urge, and mixed UI Kim, 2001547 48 women 20-75 Drug or surgery Continence efficacy Conventional care Country: Korea years old with treatment for intervention Aim: the effects of stress or mixed incontinence program: common continence efficacy urinary incontinence pelvic floor muscle intervention education, program on stress audiovisual tape, urinary incontinence calendar, in Japanese women counseling, schedule guideline, assessing self-care methods. Kim, 2007548 Women >70 years Stress UI <1/month; Fitness exercises Not described (no Country: Japan old with stress UI urge or mixed and 60-minute active intervention) Aim: the >1 per month incontinence pelvic floor muscle effectiveness of exercise sessions pelvic floor muscle two times per week; and fitness 10 fast contractions exercises in (3 seconds) and 10 reducing urine sustained leakage in elderly contractions (6–8 women with stress seconds) with 10- urinary incontinence second relaxation periods between the contractions. Kim, 2008549 Women diagnosed Stroke, dementia, Active hand Inactive hand Country: South with stress UI, Parkinson’s disease, acupuncture points, acupuncture points Korea never treated for UI multiple sclerosis, ST27, CV4 or SP15 Aim: the effect of including estrogen spinal cord injury, hand acupuncture therapy or surgery communication treatment on the problems, glycosuria or stress urinary proteinuria incontinence in women

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Kincade, 2007550 Community- Involuntary urine loss of Self-monitoring Wait list group; Country: USA dwelling women 18 less than 1 g in 24 group with training teaching a simple Aim: the efficacy of and older living in hours, positive urine on self-monitoring pelvic floor muscle self-monitoring Wake, Nash, and test for bacteria, techniques at the contraction technique techniques to surrounding diagnosis of bladder end of the second (Quick Kegel) reduce urine loss counties in North cancer or kidney visit; individualized and increase quality Carolina with disease, prior treatment counseling about of life for women involuntary urine of UI with biofeedback, caffeine with urinary loss of >1 g in 24 urinary catheter, consumption, incontinence hours available to participate amount of and for less than 1 year, timing of fluid post void residual intake, voiding frequency, and constipation; teaching a simple pelvic floor exercise Konstantinidou, Women over 18 Symptoms of urgency Common weekly Group instructions for 2007551 years with a clinical and urge incontinence session in home application of Country: Greece and urodynamic (excluded by the subgroups of 5, pelvic floor training Aim: comparative diagnosis of SUI for incontinence-specific written training and individual effectiveness of more than 3 history and the absence instructions for the followup in hospital group pelvic floor months, >7 of detrusor overactivity rest of the week, every 4 weeks. muscle training incontinence or increased bladder group instructions Individualized under intensive episodes per week, sensation during for home according to the supervision to that daytime frequency standard voiding application of pelvic strength and of individual home of less than 8 cystometry), presence floor training. endurance of pelvic therapy in women micturition of any degree of pelvic Individualized floor muscles training with stress UI episodes, nocturia organ prolapse according to the program included 3 of less than 3 strength and sets of fast episodes, positive endurance of pelvic contractions. stress test (urine floor muscles leakage) training program Kumari, 2008552 Adult women with Continuous urinary Behavioral No active therapy Country: India urinary incontinence drainage catheter, treatment with Aim: effects of those taking diuretics, educational behavioral therapy diagnosed materials, pelvic for urinary vesicovaginal fistula, floor exercises with incontinence in multiple sclerosis, at least 50 pelvic women spinal injury, severe floor contraction uterine prolapse, exercises each day, mental impairment, bladder retraining, pregnant women, and and maintenance of women who had a voiding diary and delivered a baby in last exercise record 6 months Lagro-Janssen, 110 women with Not reported Pelvic floor Usual care 1992553 self-reported urinary exercises alone Country: The incontinence (stress) or bladder Netherlands confirmed with training (urge) or its Aim: the effects of urodynamic as combination pelvic floor stress or urge (mixed) exercises on stress incontinence and bladder training on urge incontinence

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Lagro-Janssen, 66 women ages 20- Previously undergone Instructions in No therapy 1991554 65 years with an operation for pelvic floor Country: The genuine stress incontinence; if they exercises 5- 10 Netherlands incontinence suffered from sessions of 10 Aim: the effects of underlying neurological pelvic muscle pelvic floor exercise causes for contractions for 6 on urinary incontinence, from seconds each day. incontinence in diabetes mellitus or women from urinary tract infection; or if there was a temporary cause for their incontinence (for example, pregnancy) Lamb, 2009555 Women aged 18 Pregnancy; recent Group treatment Individual treatment Country: UK years and over; pelvic surgery (less Pelvic Muscle Floor Aim: To compare able and willing to than three months); Training the effectiveness of give informed history of pelvic group versus written consent with malignancy; current individual sessions an interpreter if urinary infection; grade of physiotherapy in necessary; clinical III and IV prolapse; terms of symptoms, symptoms of stress disease of the central quality of life, and and/or urge nervous system (e.g. costs, and to incontinence. multiple sclerosis, investigate the cerebrovascular effect of patient accident) or acute preference on mental illness and uptake and dementia; previous outcome of physiotherapy for treatment incontinence within the last 12 months. Lappin, 2003556 145 patients 18-65 Changes in medication Daily simulation Sham inactive device Country: USA years old with last 2 months, with low frequency Aim: Crossover, clinically definite pregnancy, pacemaker, pulsed placebo controlled multiple sclerosis chronic diseases electromagnetic RCT to examine and light spasticity fields effects of pulsed (>2 in 6 point scale) electromagnetic and bladder control fields on bladder problems control in patients with multiple sclerosis Laycock, 2001557 101 women 20-64 Moderate or severe urge Pelvic floor exercise Pelvic floor exercise Country: UK years old with urinary incontinence, with maximum for 10 minutes/day Aim: the effects of symptoms of stress moderate or severe contraction for 1 vaginal cones, urinary incontinence genital prolapse, second and rest for pressure pregnancy or plans to 4 seconds, 10 biofeedback, and become pregnant, use of minutes/day pelvic floor medications that can combined with exercises on stress affect the lower urinary home pressure urinary incontinence tract, HRT for <3 months, biofeedback using in females neurological diseases intra-vaginal perineometer

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Lee, 2001558 68 women with Detrusor instability on Periurethral Placebo (saline) Country: Canada stress urinary multichannel injections of Aim: the effects of incontinence urodynamic, co- autologous fat periurethral determined by interventions, including (30cc of fat from the autologous fat history, urinary hormone replacement, anterior abdominal injection on female leakage via the weight reduction, or wall or buttock stress urinary urethra with cough Kegel exercises, other through a single 2- incontinence provocation diagnoses causing 3mm) with 3 incontinence, including maximum injections bladder instability depending on outcomes measures Liebergall- Women at least 1 g Pregnancy or The Paula method Pelvic floor muscle Wischnitzer, urinary leakage in a breastfeeding; 12 of circular muscle training taught by ten 2009559 1-hour clinic based weeks of delivery, 6 exercises. The physiotherapists Country: Israel pad test and with weeks of abortion, or 6 Paula method was using a structured Aim: comparative the ability to months of pelvic taught by three exercise program in effectiveness of understand surgery; cardiac, registered groups of 1–10 circular muscle instructions in respiratory, psychiatric, instructors to give people for 30 minutes exercises (Paula Hebrew or English and neurological weekly individual once weekly for 4 method) or pelvic illnesses that limit 45-minute sessions weeks, followed by floor muscle physical activity; no + recommendation two more lessons 4 exercise on stress demonstrated leakage to practice daily for weeks apart each UI in women of >1 g, grade three or 45 minutes at home (overall six lessons) higher uterine prolapse Liebergall- 59 women, mainly Pregnancy, severe Paula method of Pelvic floor muscle Wischnitzer, hospital employees cardiac or respiratory circular muscle exercise 15 minutes 2005560 with stress or mixed diseases, pelvic training 15-45 with 30 minute lesson Country: Israel urinary incontinence surgery within 6 minutes/day with session/week Aim: the effects of with urine loss months, grade 3 and 4 training sessions of circular muscle >1gin pad test cystocele, previous 45 minutes/week exercises on female pelvic radiation, active urinary stress mucosal lesion in incontinence vagina or perineum Lightner, 2001561 355 women 355 women diagnosed Injection of bulking Injection of bulking Country: USA diagnosed with with stress urinary agent 1.0ml agent bovine Aim: the effects of stress urinary incontinence due to durasphere collagen maximum 5 bulking agents on incontinence due to intrinsic sphincter maximum 5 times times with a minimum stress urinary intrinsic sphincter deficiency, abdominal with a minimum 7 7 day interval incontinence due to deficiency, leak point pressure of day interval intrinsic sphincter abdominal leak less than 90cm/H2O, deficiency in point pressure of who failed prior surgical women less than and medical treatment 90cm/H2O, who failed prior surgical and medical treatment

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Lightner, 2009562 Zuidex Study Previous treatment with Non-cystoscopy Endoscopical Country: USA Group: adult bulking agents of any mid-urethral injection of Contigen Aim: Comparative women seeking type, pure predominant injection of Zuidex effectiveness of treatment for stress symptoms, mean Zuidex using a non- UI with confirmed voided volumes <200 cystoscopy mid- urodynamic stress ml on bladder diary, urethral injection incontinence with detrusor overactivity on technique vs. abdominal leak filling cystometry, Contigen injected point pressures postvoid residual endoscopically at <100 cm H2O, volumes >100 ml on 2 the bladder neck in positive pad testing occasions, or stage III the treatment of (mean urinary or IV pelvic floor urinary stress leakage of >10 g prolapse incontinence during screening secondary to intrinsic sphincter deficiency in adult women Luber, 1997563 57 women with Significant pelvic Functional electrical Sham stimulation Country: USA stress urinary prolapse and detrusor stimulation with 15- with inactive device Aim: the effects of incontinence who instability, postvoid minute treatment functional electrical could adequately residual urine >100cc, session/day using stimulation for retain the vaginal extra urethral pulse-width of stress incontinence probe and incontinence, history of 2msec scheduled in women cooperate with the vaginal intraepithelial for 2 seconds with 4 study protocol neoplasia, urinary tract seconds rest, infection, and a fixed, frequency of 50Hz, immobile urethra and power 10- 100mA. MacDiarmid, Subjects in the Not reported Percutaneous Tibial Percutaneous Tibial 2010360 OrBIT trial who Nerve Stimulation Nerve Stimulation Country: USA finished an initial Aim: To assess the course of 12 sustained consecutive weekly effectiveness of PTNS treatments PTNS therapy were offered offered at ongoing sessions of individualized therapy for an intervals during 1 additional 9 months year in subjects to monitor who finished an improvement in initial course of 12 frequency, nocturia, consecutive weekly urgency, urge sessions. incontinence episodes and voided volume. Subjects were required to be OAB drug-free throughout the study.

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Majumdar, 2010564 Patients over 18 Patients who were Urodynamics Conservative UK years of age referred for undergoing treatment based on To evaluate referred from a surgery for significant symptoms and treatment outcomes primary care with UI prolapse (stage2 or bladder diary based on baseline and other lower more) or had previous urodynamics vs. urinary tract consultation and were symptoms alone symptoms then referred for surgery for incontinence, cognitive difficulties (consent issue), neurological disorders, previous treatment for incontinence at tertiary level, recurrent dysuria or infection on urine culture Manganotti, 2007565 Women with stress Urinary tract infection, Fifteen-Hz repetitive Sham stimulation Country: Italy UI, >1 episodes of intersticial cystitis, large magnetic Aim: the short and stress UI in 3-day uterine myoma, severe stimulation of the long-term effects of diary, >2g of urine cardiac or sacral roots (S2-S4) repetitive magnetic loss in 1 hour pad cerebrovascular applied for 15 stimulation on the test disorders minutes 3 days a sacral roots week for 2 weeks (6 times in all) Manonai, 2006566 42 healthy Exclusion criteria: Self-selected diet Self-selected diet Country: Thailand perimenopausal Presence or history of with low-fat and low with low fat and low Aim: Cross-over and sex hormone cholesterol foods cholesterol foods RCT to examine the postmenopausal dependent and soy protein 25g effect of a soy-rich women between malignancies, liver or in various forms of diet on urogenital 45-70 years old renal disorders, and soy foods symptoms in peri- reported at least pathology of urogenital containing more and one type of urinary tract than 50mg/day of postmenopausal incontinence isoflavones women Mayer, 2007567 Women age 18 Morbid obesity (more Transurethral or Transurethral or Country: USA years old or older, than 100 lb over ideal periurethral soft- periurethral soft- Aim: comparative stress UI due to body weight) and a tissue augmentation tissue augmentation effectiveness of intrinsic sphincter urethral length of less of the urethral of the urethral soft-tissue deficiency without than 2.5 cm sphincter with sphincter with augmentation of the associated urethral calcium glutaraldehyde cross- urethral sphincter hypermobility hydroxylapatite; up linked bovine with calcium (straining urethral to 5 injections collagen; up to 5 hydroxylapatite vs. angle of 35° or less during 6 months injections during 6 glutaraldehyde from horizontal), months cross-linked bovine good bladder collagen in female function and stress urinary capacity (more than incontinence due to 250 mL without intrinsic sphincter detrusor instability deficiency and without associated urethral hypermobility

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study McDowell, 2006568 30 women >18 MS relapse Pelvic Floor Pelvic Floor Training Country: Northern years with multiple necessitating Training and and Advice with EMG Ireland sclerosis stabilized hospitalization 3 Advice: education Biofeedback and Aim: the effects of for the previous 3 months prior to or with booklet about neuromuscular pelvic floor training months. Expanded during the study, normal bladder electrical stimulation. and advice, Disability Status symptomatic prolapse, control, lifestyle Stimulation at clinic electromyography Scale score <7.5 presence of urinary interventions (weekly) initially for 5 biofeedback, and with at least one of tract infection, current (weight reduction, min 30 minutes using neuromuscular the following: any or recent diagnosis of a relieving pulse rate 40Hz, electrical involuntary leakage serious medical constipation, pulse width stimulation on of urine, voiding condition (other than cessation of 250msec,with 5sec urinary incontinence frequency >8/24 MS), severe cognitive smoking, caffeine on and10 sec off or in patients with hours, nocturia, impairment, reduction, fluid 10 Hz, 450msec, multiple sclerosis and/or reported contraindications to management, 10sec voiding dysfunction neuromuscular clothing, reducing such as hesitancy, electrical stimulation. emotional stress) straining, poor stream, and incomplete emptying demonstrated by uro-flowmetry. McDowell, 1999569 105 adults 60 years Folstein MMSE scores Biofeedback- Usual care with Country: USA and older, <24, severe pelvic assisted pelvic floor attention control Aim: Cross-over homebound (Health prolapse, terminal muscle training by (visits by the nurse RCT to examine the Care Financing illness, post-void nurse practitioners practitioner every 1-2 effects of behavioral Administration, residual >100ml unable skilled in behavioral weeks to provide therapies of urinary cognitively intact to toilet independently, therapies for urinary social interaction). incontinence in (Folstein Mini- no caregiver willing and incontinence. homebound older Mental State able to assist with Behavioral therapy: adults. Examination score toileting, <2 urinary 8 weekly sessions >24), with urinary accidents per week, at homes with incontinence (>2 unable to provide biofeedback- urinary satisfactory self-report assisted pelvic floor accidents/week for muscle exercises, at least 3 months), urge and stress who understand strategies, and and speak English bladder training McFall, 2000570 145 women ages Severe prolapse of Community-based Usual care Country: USA 65 or older with self uterus, hematuria, intervention with 5 Aim: the effects of reported urinary diverticulum, fistula, biweekly sessions group educational incontinence ≥3 unresolved urinary tract of education and intervention for months, residing in infection, two or more skill-building, for urinary incontinence Oklahoma. urinary tract infections bladder training, in elderly women within 3 months, urinary managing the urge obstruction, overflow to urinate, and incontinence, a performing pelvic postvoid residual muscle exercises. volume of urine (PVR) Group support by >100ml, and blood registered nurses; occupational therapist, and public health professional

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Moore, 2003573 145 consecutive Previous pelvic 2 nurse continence Outpatient regimen Country: Australia patients with stress radiotherapy, proven advisors/ patient with 15-20 minute Aim: the effects of and/or urge recurrent bacterial and consulting consultation with nurse continence incontinence with cystitis, prolapse urogynecologist for referral to advisors and idiopathic detrusor beyond the introitus, 25-35 minutes/week physiotherapist and urogynecologists in instability, sensory uterine enlargement or provided bladder bladder training. conservative urgency, and mild incomplete bladder training, gradual management of or moderate emptying (postvoid increase in fluid urinary leakage (urine loss residual >100ml). intake, individual incontinence. in 1-hour pad test 2- deferment 9.9ml/hour or 10- techniques, pelvic 50ml/hour). floor muscle exercise and examination, transvaginal electro stimulation Morkved, 2002574 103 women with involuntary detrusor Pelvic floor muscle Pelvic floor muscle Country: Norway symptoms of stress contractions on training with 3 sets training with 3 sets of Aim: the effects of incontinence and cystometry, abnormal of 10 contractions 3 10 contractions 3 individual pelvic >2g leakage bladder function times/day, times/day, floor muscle training measured by a pad (residual urine >50ml), individually individually with and without test with previous surgery for supervised by a supervised by a biofeedback in standardized stress incontinence, physical therapist. physical therapist. At women with bladder volume. neurologic or At home, 3 sets of home, 3 sets of 10 urodynamic stress psychiatric disease, 10 high intensity high intensity (close incontinence. urinary tract infection, (close to maximum) to maximum) other diseases that contractions per contractions per day could interfere with day with a without biofeedback participation biofeedback apparatus Du Moulin, 2007575 Community- Urinary tract infection, The continence Standard care Country: dwelling women PVR of 100 mL or nurse and provided by the Netherlands aged 18 years who more, delivery within 3 multidisciplinary general practitioners Aim: effects of a attended general months preceding team comprising a specialized nurse in practitioner clinic recruitment, bladder GP, urologist, the care of because of urinary cancer, renal disease, physiotherapist community-dwelling incontinence or uterine prolapse past women with urinary the introitus incontinence Nager, 2009576 Pelvic Floor Not reported Incontinence Incontinence pessary Country: USA Disorders Network pessary+ Aim: association (PFDN): women behavioral therapy between successful with stress urinary including pelvic incontinence incontinence (SUI) floor muscle training pessary fitting or and POPQ stage ≤2 and exercise and pessary size and bladder control specific pelvic strategies organ prolapse measurements in women without advanced pelvic organ prolapse

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Ng, 2008577 Women with mixed no educational A registered nurse Home based PFMT. Country: Taiwan urinary incontinence background, dependent monitoring via Education about the Aim: the effect of interested in in daily activities telephone checkups pelvic anatomy, the nursing intervention behavioral training twice a week home function of the pelvic to enhance the and potentially based PFMT. floor muscle, the efficacy of a home- available for Education about the bladder and urethra, based pelvic floor telephone contact pelvic anatomy, the the use of PFMT, and muscle exercise function of the how to perform (PFME) on mixed pelvic floor muscle, PFMT:1 hour per urinary incontinence the bladder and session, twice in community- urethra, the use of weekly, for 4 weeks dwelling women PFMT, and how to in total. perform PFMT: 1 hour per session, twice weekly, for 4 weeks in total. Nielsen, 1993578 40 women with Not reported Urethral plug as Urethral plug as oval Country: Denmark genuine urinary oval metal plate, a metal plate, a soft Aim: Cross-over stress incontinence soft stalk, and 1 stalk, and 2 spheres RCT to examine sphere along the along the stalk with effects of urethral stalk with fixed fixed distances plug on female distances between between the metal genuine urinary the metal plate and plate and the stress incontinence the spheres. Inside spheres. Inside the the stalk is a stalk is a removable removable semi- semi-rigid guide pin rigid guide pin to to ease insertion. ease insertion. Nygaard, 1995579 20 female Prolapse of the uterus, 40-minute 40-minute Country: USA exercisers ages 33- stenotic vagina, or standardized standardized Aim: Crossover 73 with urinary pelvic mass. aerobics session aerobics sessions RCT to examine the incontinence during wearing a Hodge with no mechanical effects of Hodge exercise and pessary with device pessary with positive coughing support 40-minute support, a super test. standardized tampon on urinary aerobics sessions incontinence during wearing a super exercise. tampon Nygaard, 1996580 71 women non Genital prolapse past Pelvic floor muscle Pelvic floor muscle Country: USA pregnant women the vaginal introitus, exercises with 2 5- exercises with 2 5- Aim: the effects of >21 years old with parturition within the minute daily minute daily pelvic floor muscle urinary preceding 6 months, sessions, beginning sessions, beginning exercises in incontinence. and deafness with contractions for with contractions for combination with 4-8 seconds in 4-8 seconds. specially designed combination with audiotape on specially designed stress, urge, and audiotape with 270 mixed urinary minutes of music incontinence in and verbal women. instructions of technique tips, reminders, and exercise cues.

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study O’Brien, 1991581 561 adults ages 35 Urinary tract infection. Four sessions of Usual care Country: England years and older with pelvic floor Aim: the effects of regular urinary exercises and pelvic floor incontinence (two or bladder retraining exercises and more leaks in any supervised by non- bladder retraining one month). specialist nurse. supervised by non- specialist nurse on urinary incontinence in adults with regular urinary incontinence. O’Brien, 1996582 Female patients Reported previously Nurse-led four Postponed treatment Country: UK over 35 years from sessions of pelvic Aim: Long term two large Somerset floor exercises or (followup of general practices bladder retraining O’Brien, 1991581) with urinary depending on the effects of behavioral incontinence two or dominant symptoms training on urinary more leaks in any (stress or urge incontinence in one month respectively) adult women Oldham, 2010583 Women with urinary Not reported Pelvic Floor Pelvic Floor Country: Canada incontinence were Exercises obtained Exercises obtained Aim: Evaluation of a recruited via a from Bladder and from Bladder and self-contained, fully process of self Bowel Foundation + Bowel Foundation automated, referral through ads Femestin device disposable device placed in local (Femestin), with newspapers and on application similar local radio to reflect to that of a tampon future practice

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study O’Sullivan, 2003584 Women with Previous pelvic Nurse continence Routine Country: Australia urodynamically radiotherapy, proven adviser with the first urogynecology Aim: the effect proven GSI, DI, or recurrent bacterial visit of 45 minutes outpatient therapy modification by Sumild (2-9.9 g) to cystitis, prolapse with pelvic floor with a referral note to baseline severity of moderate (10-49.9 beyond the introitus, digital testing, a physiotherapist any urinary g) incontinence (as uterine enlargement of verbal biofeedback , (SUI) or educational incontinence on judged by weight duration more than 12 bladder training with videotape about continence rates gain on 1-hour pad weeks, or incomplete individual deferment bladder training (Urge after nurse testing) bladder emptying techniques; UI) or anticholinergic intervention in (residual >100 ml) followup weekly therapy (DI) women with visits of urodynamic UI approximately 30 minutes with re- exam of pelvic floor muscle Pages, 2001585 51 women, referred Not reported Specific physical Biofeedback training Country: Germany by gynecologists for therapy program. daily 90-minutes in Aim: the effects of nonoperative Group therapy 5 group and individually intensive group treatment of times/week and for 15 minutes, 5 physical therapy genuine stress home pelvic floor times/week; Intra program with incontinence of exercise with 50 vaginal pressure individual mild-to-moderate contractions for 10 sensor and visual biofeedback training severity. minutes 2 biofeedback in for female patients times/day. computer monitor with urinary stress Recommendation of incontinence. weight loss and aerobic sports. Peters, 2010586 Women and men Pregnant or planning to Percutaneous tibial Placebo Country: USA ≥18 years of age; a become to pregnant nerve stimulation Aim: To compare score of ≥4 on the during the study; the efficacy of OAB-q short form neurogenic bladder; PTNS to a validated for urgency; Botox use in bladder or sham average urinary pelvic floor muscles frequency of ≥10 within the past one voids per day; self- year; pacemakers or reported bladder implantable symptoms ≥3 defibrillators; current months; self- urinary tract infection; reported failed current vaginal conservative care; infection; use of discontinued all Interstim; use of Bion; antimuscarinic for current use of TENS in ≥2 weeks; capable pelvic region, back or of giving informed legs; previous PTNS consent; treatment; use of ambulatory and investigational able to use toilet drug/device therapy independently within past 4 weeks; without difficulty; and participation in any and capable and clinical investigation willing to follow all involving or impacting study-related gynecologic, urinary or procedures renal function within past 4 weeks

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Peters, 2010587 This analysis Pregnant or planning to Percutaneous Tibial Placebo Country: USA includes only those become to pregnant nerve stimulation Aim: To compare subjects who during the study; the efficacy of previously used neurogenic bladder; PTNS to a validated OAB pharmacologic botox use in bladder or sham in subjects therapy prior to their pelvic floor muscles who have participation in the within the past one previously used study. Women and year; pacemakers or OAB pharmacologic men ≥18 years of implantable therapy age; a score of ≥4 defibrillators; current on the OAB-q short urinary tract infection; form for urgency; current vaginal average urinary infection; use of frequency of ≥10 Interstim; use of Bion; voids per day; self- current use of TENS in reported bladder pelvic region, back or symptoms ≥3 legs; previous PTNS months; self- treatment; use of reported failed investigational conservative care; drug/device therapy discontinued all within past 4 weeks; antimuscarinic for and participation in any ≥2 weeks; capable clinical investigation of giving informed involving or impacting consent; gynecologic, urinary or ambulatory and renal function within able to use toilet past 4 weeks independently without difficulty; and capable and willing to follow all study-related procedures. Ramsay, 1996588 Women with Previous treatment for Bladder retraining Bladder retraining Country: Scotland urgency, nocturia, their incontinence, and physiotherapy and physiotherapy as Aim: comparative urge incontinence symptoms of as an inpatient 5- an outpatient with two effectiveness of and stress hematuria, recurrent day hospital stay 2-hour sessions, 1 inpatient vs. incontinence dysuria or voiding week apart. outpatient difficulty, or infection on behavioral urine culture treatment for urinary incontinence in women

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Richter, 2010363 ATLAS trial: Previously reported in Behavioral therapy Pessary + Behavioral Country: USA Women at least 18 Richter, 2007589 therapy/Pessary Aim: To compare years old with alone the effectiveness of symptoms of stress a continence only or stress- pessary to predominant mixed- evidence-based incontinence behavioral therapy symptoms for stress incontinence and to assess whether combined pessary and behavioral therapy is superior to single modality therapy Robinson, 2003590 24 women 30-75 Overflow incontinence Urethral device Reliance insert sterile Country: Canada years old with or neurogenic bladder, (NEAT) –sterile balloon type device Aim: the effects of mixed or stress type III incontinence, urethral insert with new urethral device urinary incontinence kidney inflammatory disposable or the reliance >2 episodes/week diseases, urinary tract applicator packaged insert on female >2g urine loss on infection, use of with device. urinary baseline pad weight anticoagulants or incontinence. test, with sound incontinence mental condition, medications, allergy to willing to use >3 antibiotics, diabetes devices/week. mellitus type II, pregnancy, urethral mucosal abnormalities, prosthetic heart valve, HRT last 3 months, collagen injections or other urethral bulking agents last 3 months, detrusor contraction >20cm/H20. Sand, 1995591 52 community Detrusor instability, Active pelvic floor Sham inactive device Country: USA dwelling women pregnancy, pacemaker, stimulator with Aim: the effects of with urodynamically prior pelvic floor gradually adjusted transvaginal proven genuine stimulation, pelvic 60-80mA from 5 electrical stress incontinence, implanted devices, seconds on/1 stimulation in who would comply active vaginal lesions or second off for 15 treating genuine with visits, not infections, urinary tract minutes to 5 stress incontinence. use/seek other infection, seconds on/5 treatment for hypermenorrhea or seconds off for 30 incontinence. menorrhaghia, urinary minutes. retention (>100ml), pelvic surgery in past 6 months

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Schreiner, 2010592 52 patients from the Presence of urinary Transcutaneous Bladder training Brazil Urogynecology infection during the electrical tibial To examine the Section of the recruitment process, nerve stimulation + efficacy of Gynecology prior surgery for urinary Bladder training transcutaneous Department in Sao incontinence, history of electrical tibial Lucas Hospital of genito-urinary cancer, nerve stimulation Pontificia prior pelvic irradiation, (TTNS) to treat urge Universidade pure stress urinary urinary incontinence Catolica do Rio incontinence, genital (UUI) in older Grande do Sul in prolapse above the women the city of Porto second degree of Alegre with Walker, and inability to complaint of urge perform the Kegel incontinence and exercises. age of 60 years or more. Schulz, 2004593 40 women ages 18- Other treatments for Periurethral route of Transurethral route of Country: Canada 80 years old, with incontinence, urinary injection of bulking injection of bulking Aim: the effects of genuine stress tract infection, bladder agent-dextran agent-dextran periurethral and incontinence for capacity <250ml or copolymer copolymer transurethral >12 months, or postvoid residual injections of bulking mixed incontinence volume >100ml, agents on stress with a minor and neurogenic bladder, urinary incontinence controlled urge grade 3 cystoele, in females. component, who uterine prolapse or failed 3 months rectocele, radiation of conservative urethra, pregnancy, life treatments. expectancy <15 months. Seo, 2004594 120 patients, who Not reported Pelvic floor exercise Vaginal cone, 150g Country: South required a non- (5 second dumbbell-shaped Korea surgical treatment contraction and 10 made of fine ceramic Aim: the effects of for urinary second relaxation, material. vaginal cone with incontinence. 3-5 times for >5 conventional FES- minutes/day) and biofeedback functional electrical therapy for female stimulation urinary biofeedback (35Hz- incontinence. 50Hz for 24 seconds); 2 training sessions/week. Sherman, 1997595 39 female active Not reported Pelvic muscle Pelvic muscle Country: USA duty soldiers with exercises with exercises with Aim: the effects of exercise-induced contractions for 10 contractions for 10 pelvic muscle urinary incontinence seconds and seconds and exercises with (stress or mixed). relaxation for 10 relaxation for 10 urethral seconds 5 seconds 5 biofeedback on times/session, 20 times/session 20 exercise-induced minutes twice/day minutes twice/day urinary incontinence with urethral alone. in female soldiers. biofeedback using vaginal EMG probe.

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Smith, 1996596 57 women with Type 3 stress urinary 18 women with Kegel exercise Country: USA urinary incontinence, stress urinary Aim: the effects of incontinence. pregnancy, urinary incontinence: intravaginal retention, vaginal Electrical electrical prolapse, cardiac stimulation using stimulation on pacemaker, mixed frequency 12.5Hz.- genuine stress incontinence with no 50Hz and amplitude urinary incontinence major and minor 5-10mA-80mA for and detrusor components. 15 to 60 minutes instability in women. 2/day 38 women with detrusor instability Anticholinergic therapy with Propantheline bromide in dose of 7.5 to 4 Spruijt, 2003597 51 women ≥65 Persistent urinary tract Intravaginal Kegel exercise Country: The years of age, with infection (positive urine electrical program with verbal Netherlands symptoms of stress, culture after antibiotic stimulation of the instructions on how to Aim: the effects of urge or mixed treatment), recurrent pelvic floor using exercise at home. intravaginal urinary incontinence urinary tract infection stimulator electrical of >3 months’ (within 4 weeks after generated biphasic stimulation of the duration, and with treatment), bladder current pulses with pelvic floor for urinary leakage pathology or duration of 1ms and urinary incontinence >10cc/24hours. dysfunction because of a frequency of 50Hz in elderly women. fistula, tumor, pelvic (stress urinary irradiation, neurological incontinence) or or other chronic 20Hz (urge urinary conditions (diabetes incontinence). mellitus, Parkinson’s disease), genital, pacemaker, and insufficient mental condition. Strasser, 2007598 63 females 36-84 Urge incontinence and Transurethral Conventional Country: Austria years old with pronounced ultrasonography- endoscopic injections Aim: the effects of intrinsic sphincter hypermobility of the guided injections of of collagen; regular ultrasonography- insufficiency or urethra. autologous training of the guided injections of stress urinary myoblasts and rhabdosphincter for autologous cells or incontinence with fibroblasts; regular 12 weeks and trans endoscopic only mild training of the vaginal electrical injections of hypermobility of the rhabdosphincter for stimulation for 4 collagen on stress urethra and the 12 weeks and trans weeks urinary urinary bladder; vaginal electrical incontinence. good state of health stimulation for 4 who failed pelvic weeks. floor muscle exercises.

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Subak, 2002599 Women 55 years Uncontrolled diabetes 6 weekly 20-minute Usual care Country: USA and older with self mellitus, urinary tract group instructional Aim: the effects of reported urinary infection, history of sessions on bladder low-intensity incontinence, urinary obstruction, training by nurse behavioral therapy members of health overflow, functional educators and program on urinary maintenance incontinence, urinary followed incontinence in organization, living tract anomalies individualized older women independently in the voiding schedules. community and functionally capable of independent toileting. Subak, 2005600 48 women 18 to 80 Exclusion criteria: Weight reduction Usual care Country: USA years old with body pregnancy, urinary tract intervention: 3- Aim: the effect of mass index infection, significant month standard low weight loss on between 25 and 45 medical condition, calorie liquid diet urinary incontinence kg/m2, urinary pelvic cancer, (800kcals/day or in overweight and incontinence for at neurological condition less), increased obese women. least 3 months and possibly associated physical activity to at least 4 with incontinence, 60 minutes/day, incontinent interstitial cystitis or training by a episodes/week, the potential inability to nutritionist, exercise stable dose of other complete the study. physiologist or incontinence behavioral therapist therapy . Subak, 2009601 Women at least 30 Pregnancy, urinary tract Intensive 6-month Structured education Country: USA years of age, a infection, significant weight-loss program: four Aim: effectiveness body-mass index of medical condition, pelvic program to produce education sessions at of weight loss on 25 to 50, >10 cancer, neurological an average loss of months 1, 2, 3, and 4. urinary incontinence urinary- condition possibly 7 to 9% of initial During these 1-hour in obese women incontinence associated with body weight that group sessions, episodes/week, incontinence, interstitial included diet, which included 10 to ability to walk cystitis or potential exercise, and 15 women, general unassisted for two inability to complete the behavior information was blocks study. modification presented about (approximately 270 (AHEAD ,Action for weight loss, physical m) without stopping Health in Diabetes) activity, and healthful trial eating habits Sung, 2000602 90 married women Not reported. Functional electrical Control usual care Country: Korea with urinary stimulation- Aim: the effects of incontinence. biofeedback for 20 pelvic floor muscle minutes/session exercises on female with frequency genuine stress 35Hz-50Hz and incontinence. contractions of 32 seconds, 2 sessions/week Intensive pelvic floor muscle exercises

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Sung, 2000603 Married women Not reported Intensive pelvic Functional electrical Country: South diagnosed with floor muscle stimulation (FES)- Korea genuine stress UI exercise at home, biofeedback for 20 Aim: comparative videotape with minutes/session, 2 effectiveness of instructions to sessions/week and pelvic floor muscle perform exercise, weekly examination exercise and the weekly examination of accuracy and functional electrical of accuracy and intensity of stimulation - intensity of contractions. Pelvic biofeedback for contractions electrical stimulation female urinary for 24 seconds at 35 incontinence and 50 Hz simultaneously followed by biofeedback Swithinbank, 69 women with Urinary tract infection, 1. Increased Usual care 2005604 urodynamically hepatic, cardiac or decaffeinated fluids Country: England proven stress renal disease and to 3 liters daily (20 Aim: Cross-over incontinence naive diabetes mellitus, use cups) or decreased RCT to examine the to surgery. of antidepressants, decaffeinated fluids effect of caffeine anticholinergics or to 750ml (5 cups) restriction and fluid diuretics. daily manipulation in the 2. Caffeine treatment of restriction and patients with increased fluid urodynamic stress intake to 2, incontinence. 2,673ml/day 3. Caffeine restriction and decreased fluid intake to 872ml/day Tibaek, 2007605 Women, diagnosed Urinary tract infection; Systematic, Standard program of Country: Denmark with first ever symptoms of controlled, intensive rehabilitation for Aim: the long term ischemic stroke descensus urogenitale; pelvic floor muscle patients with stroke effect of pelvic floor according to the chronic respiration training program by without any specific muscle training in definition of World diseases; psychiatric the specialist treatment of urinary women with urinary Health Organization diseases; other physiotherapist: incontinence incontinence after and verified by CAT neurological diseases; group treatment stroke scan, stroke and do not speak with 6–8 symptoms in at Danish. patients/group for 1 least one month; hour/week, vaginal normal cognitive palpation 2-3 times function (mini- and home exercises mental state 1-2 times daily examination a.m. Folstein >25)

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Theofrastous, 137 community- Reversible causes of Pelvic floor muscle Bladder training 2002606 dwelling women 45 urinary incontinence, training: 4 office Country: USA years and older uncontrolled metabolic biofeedback Aim: the efficacy of diagnosed with conditions, residual sessions and home bladder training and genuine stress urine volume after exercise with two pelvic muscle incontinence, (urine voiding >100ml, urinary sets of 5 quick and exercise with loss at least once tract infection, 10 sustained biofeedback- per week), with genitourinary fistula or contractions with assisted instruction urodynamic indwelling 10-second rest on urinary evidence of genuine catheterization, and periods increased incontinence in stress incontinence, inability to correctly to 5 quick and 20 women. and mentally intact perform a pelvic muscle sustained (Mini-Mental State contraction contractions 2/day Examination Score for a total of 50 >23). contractions per day Thornburn, 1997607 Women with light Not reported Pad A with the Pad B with the Country: UK urinary incontinence largest wetback largest strike-through Aim: the who used time; Pad F with the relationship disposable largest absorption between pad incontinence pads capacity properties (absorption capacity, strike- through, and wetback) and wet comfort in women with light urinary incontinence Thyssen, 2001608 94 women with the Major uterovaginal Conveen Contrelle Continence Country: Denmark predominant prolapse Continence Guard, Tampon, CCT, Aim: Crossover symptom of stress CCG made of Coloplastic made of RCT to examine the incontinence, 39 hydrophilic hydrophobic effects of were recruited in polyurethane and polyurethane and disposable Denmark, 28 in requires soaking in supplied ready- intravaginal device England, and 27 in water before being assembled within an on stress Australia. placed on a handle applicator, allowing incontinence in like applicator for insertion directly into women. insertion. the vagina with no manual contact

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Tibaek, 2004609 Women diagnosed Urinary tract infection; Systematic, The normal, standard Country: Denmark with first-ever symptoms of controlled, intensive program of Aim: the effect of ischemic stroke descensus urogenitale; pelvic floor muscle rehabilitation without pelvic floor muscle according to the chronic respiration training program in any specific training in women definition of the diseases; psychiatric 12 consecutive treatment of urinary with urinary World Health diseases; other weeks by the same incontinence incontinence after Organization and neurological diseases; specialist ischemic stroke verified by CAT and do not speak physiotherapist. scan; stroke Danish Women received symptoms in at instructions how to least 1 month; perform strength normal cognitive PFM exercise with function (Mini- close to maximum mental state contraction (6 s examination a.m. contraction/6 Folstein >25) seconds relaxation Tibaek, 2005610 26 women 40 and Urinary tract infection; Intensive pelvic Usual care Country: Denmark 85 years old with symptom of vaginal floor muscle training Aim: the effect of acute ischemic prolapse; chronic 1-2 times/day by pelvic floor muscle stroke verified by respiratory diseases; specialized training in women CAT scan lasting psychiatric diseases; physiotherapist: with urinary >24 hours; stroke other neurological group information incontinence after symptoms in at diseases; does not on incontinence and ischemic stroke. least 1 month; speak Danish. instruction in self- normal cognitive palpation of PFM, function (mini- motivation and mental state instruction in home examination >25); exercises urinary incontinence related to stroke; independent walking Tsai, 2009611 Women who Severe uterine Interpersonal Pelvic floor muscle Country: Taiwan presented to the prolapse, past the support and digital exercise training with Aim: comparative family medicine vaginal introitus, heart vaginal palpation as a printed handout effectiveness of outpatient clinic failure; history of part of the pelvic instruction interpersonal without having urine dementia (Mini-Mental floor muscle support and digital leakage as their State Examination exercise training. vaginal palpation as chief complaint but (MMSE) score <24); The researcher part of the pelvic with transient UI prior knowledge of contacted the floor muscle PFME prescribed by a patients of exercise training physician, a nurse, a experimental group compared to pelvic physical therapist, or by telephone once floor muscle any other health per week to inquire exercise training problems about any with a printed difficulties and/or handout instructions improvements on stress urinary incontinence

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Williams, 2006615 Women ≥40 years Pregnant, had urinary Pelvic floor muscle Standard care: leaflet Country: were randomly fistula, pelvic therapies training with information Aim: the efficacy sampled by malignancy, severe by specially trained about pelvic floor and cost- household from the prolapse and those nurses, after an muscles and three effectiveness of Family Health currently receiving initial digital steps in exercising pelvic floor muscle Service Authority treatment for urinary assessment and these muscles therapies (PFMT) in registers of symptoms (e.g. on a perineometry to women ≥40 years participating GP waiting list for develop with urodynamic practices and continence surgery). individualized stress incontinence invited if they had exercise regimen. (USI) and mixed UI urodynamic diagnosis of USI or mixed UI and DO Wing, 2010616 Being at least 30 Reported Previously in Behavioral weight Structured education Country: USA years old, having a Subak, 2009601 loss program program Aim: To examine BMI of 25 to 50 the longer term kg/m2, reporting at effects of a weight least 10 UI loss intervention on episodes on a 7- urinary day voiding diary at incontinence. baseline and agreeing not to initiate new treatments for incontinence or weight reduction during the trial. Wong, 2001617 Chinese women Second or third degree Biofeedback from Biofeedback from Country: China with genuine stress uterine prolapse, the abdominal pelvic floor muscles Aim: the efficacy of incontinence previous failure of muscle contractions during pelvic floor biofeedback in pelvic floor muscle during pelvic floor exercises Chinese women exercise, continence exercises with EMG with urinary stress surgery, pad test with attached over their incontinence urine loss <2g, abdominal muscles neurologic disease Wyman, 1997618 131 women 55 Metabolic Bladder training: Usual care Country: USA years and older, decompensation, patient education, Aim: the effects of ambulatory, urinary tract infection, progressive bladder training on mentally intact, outlet obstruction, scheduled voiding quality of life in independent fistula, reversible cause regimen, positive older women with residents in the of urinary incontinence, reinforcement. urinary community with permanent indwelling incontinence. urodynamic stress catheter. urinary incontinence >1 episode/week.

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Wyman, 1998619 204 community- Reversible causes of Structured 12-week Bladder training Country: USA dwelling women urinary incontinence, program of patient Aim: the efficacy of age 45 years and uncontrolled metabolic education, self- bladder training, older diagnosed conditions, residual monitoring of pelvic muscle with genuine stress urine volume after voiding behavior exercise with incontinence, (urine voiding >100ml, urinary with daily treatment biofeedback- loss at least once tract infection, logs, compliance assisted instruction, per week), with genitourinary fistula or assessment, and and combination urodynamic indwelling positive therapy, on urinary evidence of genuine catheterization, and reinforcement incontinence in stress incontinence, inability to correctly administered by women. and mentally intact perform a pelvic muscle trained registered (Mini-Mental State contraction nurses. Examination Score >23). Yamanishi, 1997620 35 patients with Persistent urinary Electrical pelvic Sham electrical pelvic Country: Japan stress incontinence. infection, uterine or stimulation with stimulation with Aim: CT to examine rectal prolapse and 50Hz. square inactive device the effects of cystocele, severe waves of 1msec. electrical pelvic cardiac or pulse duration and stimulation in stress cerebrovascular vaginal electrode in incontinence. disorders including on- women and an anal demand heart electrode in men for pacemakers, hepatic 15 minutes 2 or 3 disorders and renal times daily dysfunction. Anticholinergics, calcium antagonists, alpha or beta agonist Yamanishi, 2000621 68 patients with Use of anticholinergics Electrical Sham inactive device Country: Japan urinary incontinence or tricyclic depressants, stimulation 15 Aim: the effects of due to detrusor pelvic floor exercise, minutes twice daily electrical overactivity bladder training, or for 4 weeks (vaginal stimulation for urodynamically pelvic surgery before electrode in women urinary incontinence defined as entry into the study. and an anal or due to detrusor involuntary detrusor surface electrode in overactivity contractions of men to provide more than alternating pulses of 15cm/H2O during 10Hz square waves the filling phase. of 1-ms pulse duration and a maximum output current of 60mA).

Appendix Table F81. Randomized controlled clinical trials of nonpharmacological nonsurgical treatment for UI (continued) Reference country Inclusion criteria Exclusion criteria Active treatment Control treatment aim of the Study Yoon, 2003622 50 parous women Urinary tract infection Bladder training Usual care Country: South 35–55 years old tested by urinalysis and with increased Korea with urine loss of urine culture, previous interval between Aim: the 1.0g or more on a experience of surgery voluntary voids ; effectiveness of 30 minute pad test for urinary Pelvic muscle bladder training and 14 voids or incontinence, HRT and exercise (30 versus pelvic more during a other medication for contractions for 15 muscle exercises in period of 48 hours urinary incontinence. to 20 minutes/day) the treatment of before the with immediate and urinary incontinence preliminary simultaneous visual in women. evaluation. feedback of pelvic muscles during a 20 minute weekly biofeedback session Zanetti,2007623 Women with stress Topical hormone Supervised perineal Unsupervised Country: Brazil urinary incontinence replacement therapy for exercises repeated perineal exercises Aim: comparative confirmed by less than three months, in the orthostatic, repeated in the effectiveness of means of disorder affecting sitting and supine orthostatic, sitting pelvic floor muscle urodynamic testing muscle or nerve positions under and supine positions exercises with or tissues, or genital guidance from a performed at home without bleeding, pregnancy, physiotherapist with monthly physiotherapist urinary tract infection, (twice a week, for assessment from a supervision on vulvovaginitis, genital 45 minutes). physiotherapist. female stress UI prolapse beyond the hymen, atrophic vaginitis or cardiac pacemaker Clarke-O’Neill, The Continence Not reported 10 pants designed Cross over evaluation 2002624 Product Evaluation for light Country: UK Network: women 18 incontinence Aim: The years of age and Continence Product normally used an Evaluation Network: absorbent product comparative survey (disposable or of washable pants reusable) for light with integral pads incontinence for women with light incontinence Tomlinson, 1999625 The Behavioral Diagnosis of bladder The Behavioral No active treatments; Country: USA Management for cancer or kidney Management for alternative resources Aim: The effects of Continence disease; use of a Continence: self- within the community dietary caffeine and (BMC):women 55 or urinary catheter; monitoring (2–4 fluid intake on older living in their retention of 100 ml or weeks’ duration); urinary incontinence own home in one of more of urine; need for bladder training (6– in older rural seven rural counties a caregiver but none 8 weeks’ duration); women in northern Florida was available; and and pelvic muscle with involuntary availability for less than exercise with urine loss at least 6 months biofeedback (12 twice a week and of weeks’ duration). 1 g per day or more The goal was appropriate intake of 1800–2400 ml/day of fluids