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Demystifying : Identifying the Cause and Tailoring the Treatment

Paula Laureanno, Pamela Ellsworth

octuria is a highly Nocturia is a common problem with a significant impact on quality of life. The prevalent and bother- etiology of nocturia is multifactorial. Recent standardized terminology with some condition with respect to nocturia has been developed to promote more efficient communica- significant health- tion among providers/specialists. A careful history, physical examination, and Nre lated consequences. Patients use of a voiding diary are important steps in identifying the etiology of nocturia with nocturia may present to mul- and assist in tailoring the treatment regimen. tiple practitioners, including a © 2010 Society of Urologic Nurses and Associates urologist, gynecologist, geriatri- Urologic Nursing, pp. 276-287. cian, neurologist, expert, endocrinologist, and primary care provider. Each practitioner/spe- Key Words: Nocturia, , voided volume. cialty may approach patients from a different perspective. Therefore, it is important that some of the Objectives basic terms surrounding nocturia 1. Define nocturia. have specific definitions so each 2. Explain the impact of nocturia on sleep. individual provider refers to the 3. Discuss the evaluation of nocturia. same condition in his or her clin- ical evaluation and management. 4. Explain the treatment options currently being used for patients with nocturia.

Despite its impact, nocturia Prevalence of Nocturia has been poorly described and Historically, the definition of Paula Laureanno, RN, is a Staff Nurse, managed. In 2002, the Inter- nocturia has varied, making it dif- University Urological Associates, Providence, national Continence Society (ICS) ficult to arrive at a precise preva- RI. defined nocturia as the complaint lence figure. Furthermore, few epi- the individual has to wake at night Pamela Ellsworth, MD, FACS, FAAP, is an demiologic studies have been per- one or more times to void (Abrams Associate Professor of (), formed in the . Warren Alpert School of Medicine, Brown et al., 2003). The standardization Nocturia prevalence has been University, Providence, RI. subcommittee of the ICS further reported to be between 58% and defined the terminology related to Statements of Disclosure: Pamela 66% in women and men ages 50 nocturia so that colleagues in dif- Ellsworth, MD, FACS, FAAP, disclosed that to 59 years, and 72% and 91% she is on the consultant/presenter bureau for ferent specialties could communi- in women and men over 80 Novartis and , receives grant support cate effectively with respect to years, respectively (Middelkoop, from Novartis, and is on the advisory board nocturia. Developments in the for Pfizer and Allergan. She further disclosed Smilde- van den Doel, Neven, characterization of nocturia have that there is mention of off-label drug use in Kamphuisen, & Springer, 1996). In allowed for simplified and concise this article, stated as “not FDA-approved” in a more recent national survey con- the text. approaches to the evaluation of ducted by telephone of 5204 com- patients presenting with nocturia. munity-based adults with an aver- Paula Laureanno, RN, reported no actual or A greater understanding of the eti- potential conflict of interest in relation to this age age of 45.8 years, 31% report- ologies of nocturia has promoted continuing nursing education article. ed at least one void per night, and the development of more focused 14.2% reported at least two voids Note: Objectives and CNE Evaluation Form treatment strategies. appear on page 287. per night (Coyne et al., 2003).

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Studies in Japan and Austria, in Table 1. which nocturia was defined as Nocturia Terminology and Definitions two voids or more per night, found rates of 28.5% and 11.3%, Term Definition respectively (Schatzl et al., 2000; Night time The period of time between going to Yoshimura et al., 2004). with the intention of sleeping and waking with the intention of rising. Nocturia The number of voids recorded during a Impact of Nocturia night’s sleep. Each void is preceded and fol- The impact of nocturia is sig- lowed by sleep. nificant. A number of studies has Nocturnal volume Total volume of urine passed during the demonstrated that a high propor- night including the first morning void. tion (63% to 75%) of individuals with nocturia perceive it to be Rate of nocturnal urine production The nocturnal volume/time asleep (for troublesome (Jolleys, Donovan, example, night), measured in ml/minutes. Nanchahal, Peters, & Abrams, Nocturnal polyuria The production of an abnormally large vol- 1994; Scarpa, 2001; Swithinbank ume of urine during sleep – Should include et al., 1999). Nocturia has a signif- all urine produced after going to bed and icant impact on sleep, and accord- the first void after arising, nocturnal volume ing to Marschall-Kehrel (2004), greater than 20% to 30% of total 24-hour uninterrupted sleep is necessary urine volume (age dependent). for the maintenance of physical, mental, and emotional well-being. 24-hour voided volume Total volume of urine voided during a 24- In a Dutch cross-sectional epi- hour period (first void to be discarded; 24 hours begins at the time of the next void). demiologic study, nocturia was found to be one of the two most Polyuria 24-hour voided volume in excess of 2800 important causes of sleep distur- ml in a 70 kg person or more than 40 ml/kg. bance in adults over 50 years of age (Middelkoop et al., 1996). In Night time frequency The number of voids recorded from the time an elderly population in Sweden, the individual goes to bed with the intention of going to sleep, to the time the individual nocturia was found to be associat- wakes with the intention of rising. ed with an increased prevalence of sleep disorders, poorer quality First morning void The first void after waking with the intention sleep, and increased day time of rising. fatigue (Asplund & Aberg 1992). Maximum voided volume (MVV) The largest single voided volume measured This population experienced fre- in a 24-hour period. quent awakenings and a general feeling of insufficient and non- Nocturia index (Ni) Mean-measured nocturnal urine volume restorative sleep. In addition, nor- (NUV) divided by the functional bladder capacity (deduced from the frequency vol- mal somatic symptoms, such as ume chart). An Ni greater than 1 means that muscle cramps in the calves, leg nocturnal urine production is greater than tingling, and nocturnal sweating, the functional bladder capacity. are also increased in parallel with increasing number of voids Nocturnal polyuria index (NPi) Mean-measured nocturnal volume/24-hour (Asplund & Aberg 1992). The voided volume. NPi greater than 33% changes in sleep associated with implies nocturnal polyuria as opposed to diurnal polyuria. nocturnal voiding result in day time sleepiness and impaired per- Nocturia bladder capacity index The difference between the actual number ception and balance, which can (NBCi) of nocturnal voids (ANV) and the predicted also increase the risk of fall number of nocturnal voids (PNV). The injuries (Van Balen et al., 2001). In greater the NBCi, the more often nocturia is a study of night time falls in the occasioned by nocturnal voided volumes smaller than the MVV. elderly, it was found that the occurrence of two or more noctur- Predicted number of nocturnal voids Ni minus 1. nal voids was associated with a two-fold increase in falls com- Source: Abrams et al., 2003. pared with fewer than two voids (Stewart, Moore, May, Marks, & Hale, 1992).

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Nocturia is associated with an Table 2. increased mortality. In an epi- Causes of Polyuria demiologic study of over 6000 Mellitus Type 1 (IDDM) and Type 2 (NIDDM) men and women 65 years of age and older in northern Sweden, 190 men and 287 women reported Pituitary having three or more nocturnal Renal voids. Fifty-four deaths were noted among the men with three Secondary nephrogenic due to: or more nocturnal voids and 34 deaths among the women. The Electrolyte disturbances – Hypercalcemia, death rate was twice as high for Primary males and females, with three or more voids per night as all men Psychogenic and women in the study Dipsogenic (Asplund, 1999). Finally, there is Iatrogenic some evidence to suggest that may have an effect on the function of the Nocturnal Polyuria uria can be divided into those that immune system (Benca & Urine output normally de- cause a water or a solute/ Quintas, 1997) and that sleep is creases during the night. This water diuresis (see Table 3.). important in maintaining host appears to be related to a corre- Congestive , low defenses (Irwin et al., 1996). sponding increase in secretion of volume, venous stasis dis- hormone (ADH). As ease, and high intake of salt may Terminology Related to Nocturia ADH secretion increases, there is result in third spacing of fluid in increased resorption of water from the lower extremities, which can ICS has developed several the renal tubule, resulting in lower contribute to fluid retention asso- definitions for terms that apply to volumes of concentrated urine. ciated with nocturnal polyuria, as the evaluation and identification The urine output during sleep can can renal insufficiency (Weiss & of the cause of an individual’s be expressed as a percentage of the Blaivas, 2000, 2002). With certain nocturia (van Kerrebroeck et al., total urine output over 24 hours if respiratory conditions such as 2002). Weiss and colleagues have the 24-hour urine output is nor- , hypoxia in the lungs also identified several parameters mal. This value can vary consider- can lead to pulmonary vasocon- pertinent to the evaluation of noc- ably from person to person and striction and increased concentra- turia (Weiss, Blaivas, & Stember, normally increases with age. tions of peptides responsible for 1998). Table 1 lists terms and def- Healthy, young adults from 21 to the elimination of sodium in the initions with respect to nocturia. 35 years of age produce 14% + 4% urine. This can result in increased Adoption of these terms by health of their total urine output between secretion of water while the care professionals evaluating and the hours of 11:00 p.m. and 7:00 patient is sleeping (Krieger et al., managing nocturia will allow for a a.m. (95% confidence interval [CI] 1993). more efficient communication 10% to 19%) (Robertson et al., among providers/specialties. 1999), whereas older adults pro- Bladder Storage Problems – duce an average of 34% + Reduced Voided Volumes Types of Nocturia 15% (95% CI 30% to 36%) In both men and women, the (Rembratt, Robertson, Norgaard, & mean voided volumes at night are Nocturia may be related to a Andersson, 2000). on average one-third larger than variety of causes. These causes Nocturnal polyuria is defined those in the day time, irrespective can be divided into four cate- as a night time urine output of the number of nocturnal micturi- gories: polyuria, nocturnal poly- greater than 20% of the daily total tion episodes (Asplund, 1992). If uria, bladder storage problems, in young adults and 33% in older the individual’s actual number of and mixed nocturia. adults, with the value for middle night time voids (ANV) is greater Polyuria age somewhere in the middle of than the predicted number of night these two age extremes (Carter, time voids (PNV), then the night Polyuria is defined as a total 1992). Exceptions to this stratifica- time voids are occurring at volumes 24-hour urine volume greater than tion are individuals with diabetes less than the individual’s actual 40 ml/kg. Table 2 lists causes of insipidus and those whose sleep- bladder capacity. The greater the polyuria. ing patterns vary greatly from the difference between the predicted normal eight-hour night time sleep and actual numbers of nocturnal pattern. Causes of nocturnal poly- voids, the more the nocturia may

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Table 3. Evaluation of Nocturia Causes of Nocturnal Polyuria An important first step in the Secondary to Water Diuresis evaluation of nocturia is establish- ing whether the individual has Circadian defect in secretion or action of antidiuretic hormone awakened at night to void or • Primary (idiopathic) voids because the individual is • Secondary already awake. Health care ➞ providers need to be aware that Excessive intake of fluid, , alcohol there may be discrepancies ➞ CNS lesion from CVA which affects hypothalamic-pituitary axis between the actual causes of the Solute/Water Diuresis patient’s awakening and the rea- son given. In a per- Congestive heart failure formed by Pressman, Figueroa, Autonomic dysfunction Kendrick-Mohamed, Greenspon, and Peterson (1996), explanations Sleep apnea syndrome provided by patients as to the Renal insufficiency cause of their awakenings rarely Estrogen deficiency matched the “objective” findings from polysomnograms. An accu- rate history is crucial to determine Table 4. if there is a treatable underlying Bladder Storage Problems medical condition present as list- ed in Tables 2, 3, and 4. If the Decreased functional bladder capacity patient has risk factors for , further Bladder outlet obstruction with increased post-void residual evaluation with a specialist may Cancer of the bladder, , or be warranted (see Table 5). Decreased bladder contractility with increased post-void residual Eliciting any prior history of uri- nary complaints, treatments and Decreased nocturnal bladder capacity the patient’s medication usage, Detrusor over-activity the pattern of fluid intake is also Idiopathic () an important component. The voiding diary is the cornerstone of Secondary to neurogenic causes () the evaluation of nocturia. It pro- Bladder irritation vides important information regarding patterns of micturition, mean and total voided volume, /painful bladder syndrome and maximum voided volume. Bladder calculi The physical examination is use- ful to rule out a possible underly- Source: Weiss & Blaivas, 2002. ing neurologic condition, a dis- tended bladder secondary to increased post-void residual, and benign or malignant enlargement of the prostate, and to assess for be attributed to reduced voided Mixed Nocturia lower extremity edema and volumes secondary to an underly- Patients with nocturia may venous stasis . ing urologic disorder as opposed to have more than one etiology, such In patients with diurnal a medical disorder (Stember, as both nocturnal polyuria (NP) polyuria, an overnight water dep- Weiss, Lee, & Blaivas, 2007). and reduced voided volumes. In a rivation test (WDT) can distin- Problems with bladder storage study of 94 nocturic patients, noc- guish between diabetes insipidus may be related to decreased blad- turia was due to NP in 7%, and (Adam, der capacity, decreased nocturnal reduced voided volumes in 57%, 1997). If the osmolality of the first bladder capacity, detrusor over- diurnal polyuria in 23%, and a morning void is greater than 800 activity, and conditions that can mixture of NP and reduced void- mOsm/kg H2O, one can conclude cause bladder irritations (Weiss & ed volumes in 36% (Weiss et al, there is both normal secretion of Blaivas, 2002). Table 4 identifies 1998). ADH and renal response to ADH. factors that may affect bladder Polyuria with a normal WDT is storage. indicative of primary polydipsia.

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Table 5. Pharmacologic Therapy in the Risk Factors for Obstructive Sleep Apnea Management of Nocturia

Excessive weight Family history of sleep apnea There are no FDA-approved agents for the treatment of noc- Neck circumference greater than Use of alcohol, sedatives, or turia. However, depending on the 17.5 inches tranquilizers etiology of the nocturia, desmo- pressin and antimuscarinic agents Hypertension Smoking have been used to treat the noc- Narrowed airway – Naturally or Ethnicity – African Americans have turia. An oral “melt” secondary to enlarged tonsils or highest risk than any other ethnic group (Minirin, Ferring, DDAVP), an adenoids intranasal formulation of desmo- Male sex Diabetes mellitus pressin (SER-120®) (Serenity Pharmaceuticals and licensed by Postmenopausal GERD Allergan), is currently being evalu- Older age – 3 times more likely in Polycystic ovary syndrome – 3 times ated for nocturia in clinical trials. adults older than 65 years of age more likely Desmopressin (DDAVP) Desmopressin is a synthetic If the WDT is abnormal, then the In most individuals, the first analog of the antidiuretic hor- patient either has deficient pro- steps in treatment are lifestyle and mone arginine . Vaso- duction of ADH (central diabetes behavioral changes. Fluid intake pressin is secreted from the pitu- insipidus) or an inappropriate in the evening should be discon- itary gland in response to changes renal response to ADH (nephro- tinued, if possible, and alcohol in plasma osmotic pressure and genic diabetes insipidus). A renal and caffeine consumption re- increases water reabsorption from concentrating capacity test duced. For individuals with lower the . As an analog of argi- (RCCT) can distinguish between extremity edema and venous sta- nine vasopressin, desmopressin central and nephrogenic diabetes sis, the use of compression stock- increases urine osmolality and insipidus. This is accomplished ings and afternoon leg elevation decreases total urinary volume by administering demopressin may combat fluid retention before (Lose, Lalos, Freeman, van (Minirin®, Ferring®, DDAVP®) retiring at night. The use of nasal Kerrebroeck, & the Nocturia Study orally (0.4 mg) or intranasally (40 continuous positive airway pres- Group, 2003). The molecular mcg or 0.4 ml) after restricting sure can be used to treat sleep structural differences between water. The bladder is emptied, apnea, therefore reducing associ- desmopressin and arginine vaso- and a urine sample is collected ated nocturia (Appell & Sand, pressin give desmopressin a three to five hours later. A urine 2008). longer duration of action, an osmolality greater than 800 use is associated increase in antidiuretic activity, mOsm/kg demonstrates normal with a two-fold increase in noc- and a decrease in vasopressor renal concentrating ability indi- turia (Asplund, 2003). activity (Cvetkovic & Plosker, cating the patient has central dia- are generally taken in the morn- 2005). In healthy men aged 55 to betes insipidus. If the RCCT ing, which can lead to increased 70 years, oral desmopressin has a yields low urinary osmolality and increased fluid intake half-life of about three hours, with (< 500 mOsm/kg), polyuria is due later in the day, thereby increasing only minor differences between to nephrogenic diabetes insipidus nocturnal urine output (Asplund, day time and night time values. (Weiss, Weinberg, & Blaivas, 2007). If furosemide (Lasix®) is The median time required to 2008). taken six hours before going to reach the maximum serum con- bed, nocturnal diuresis may be centration is one-and-a-half hours reduced (Reynard, Cannon, Yang, regardless of administration time. Treatment of Nocturia & Abrams, 1998). In a random- The bioavailability of desmo- Once a patient has undergone ized, placebo-controlled trial com- pressin is low (8%) (Rembratt, an evaluation of nocturia and the paring night time doses of placebo Graugaard- Jensen, Senderovitz, etiology has been defined, treat- and bumetamide (Bumex®) 1 mg, Norgaard, & Djurhuus, 2004). The ment will then be tailored to the bumetamide treatment decreased gastrointestinal absorption of specific etiology. A formalized nocturia episodes by 25% com- desmopressin is decreased and diagnostic and treatment algorithm pared with placebo (Pedersen & delayed if it is administered may be useful in directing clinical Johansen, 1988). within one-and-a-half hours after care. An algorithm developed and a meal. However, there is no used in the authors’ clinical prac- observed effect of food on the tice is presented in Figure 1. pharmacodynamics of oral desmopressin. Urine volume is

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Figure 1. Clinical Algorithm for the Diagnosis and Treatment of Nocturia

Focused History and Physical

Are the symptoms disruptive to No treatment No Ye s the quality of life

Does the history and physical (H&P) reveal underlying medical condition, such as sleep apnea, which may contribute to symptoms of nocturia?

24-hour voiding diary No Ye s

Diagnosis Symptoms Persist Treat underlying cause and repeat clinical assessment

Symptoms No treatment resolved

On average, is the mean voided volume 24-hour urine *NPI > 35 **See foot note at night 1/3 larger than volume > 40 ml/kg that of day time?

Nocturnal Bladder storage Diurnal Mixed polyuria problem polyuria polyuria

Lifestyle and WDT Pharmacologic Evaluate symptoms behavioral for possible cause change therapy Diagnosis Diagnosis Diabetes insipidus Primary polydipsia

Desmopressin If OAB-related

RCCT Diagnosis Nephrogenic

Antimuscarinic Diagnosis * Age-dependant circadian agents Central diabetes Treat underlying cause – Fluids, correct pattern insipidus metabolic abnormalities, hydrochlorothiazide, ** Combination of symptoms and amiloride represented by micturation pattern, total volume, and maximum volume may represent a diagnosis of Fluid replacement, desmopressin mixed nocturia.

Alternatives to desmopressin: Synthetic vasopressin, chlorpropamide, carbamazepine, thiazide

UROLOGIC NURSING / September-October 2010 / Volume 30 Number 5 281 SERIES decreased, and urine osmolality and nocturnal polyuria have been taken. Desmopressin should be is increased to similar extents, noted with the lowest dose of discontinued if edema in the legs regardless of the timing of inges- desmopressin (0.1 mg) in individ- or other signs of fluid retention tion of food and intake of desmo- uals with pronounced symptoms occurs. If the antidiuretic effect pressin (Rittig, Jensen, Jensen, & (Asplund et al., 1998; Kuo, 2002). of desmopressin persists into the Pederson, 1998). In a study of 30 older adults (both day time, the dose may need to Desmopressin has been used men and women) (mean age 75.4 be reduced or the desmopressin since the 1960s for the treatment + 6.6 years) with three or more discontinued (Asplund, 2007). of diabetes insipidus and from the micturition episodes per night Adverse events associated early 1980s for the treatment of and nocturnal polyuria treated with desmopressin treatment nocturnal in children with oral desmopressin 0.1 mg at include headache, nausea, dizzi- (Asplund, 2007). The first reports for four weeks, nocturnal ness, and . The risk of the use of desmopressin for urine output decreased from a of hyponatremia with desmo- nocturia were published in 1993 mean of 955 + 255 ml to 522 + 210 pressin use appears to increase (Asplund & Aberg, 1993a, b). The ml (p < 0.0001). The mean num- with age and decreasing baseline recommended dose of desmo- ber of nocturnal voiding episodes serum sodium concentration pressin for nocturia is 0.1 mg to was also decreased from 5.20 + (Rembratt, Riis, & Norgaard, 0.4 mg orally at bedtime (Asplund, 1.16 to 2.24 + 1.12 per night (p < 2006). A systematic review of Sundberg, & Bengtsson, 1998). It is 0.0001) (Kuo, 2002). older adults treated with oral or recommended to start at the lowest Desmopressin use in nocturia nasal desmopressin showed an dose and assess the patient’s has been shown to improve sleep. incidence of 7.6% for hypona- response. Responders to treatment In a three-week study by tremia (Weatherall, 2004). Des- will in most cases note a reduc- Mattiasson and colleagues (2002), mopressin should be avoided in tion in nocturnal urine output and the mean duration of the first patients with primary polydipsia nocturnal voids after the first dose sleep period increased by 59% and related polyuria, cirrhosis of or at least after a few days (from 2.7 to 4.5 hours) in the the liver, renal failure, and con- (Asplund, 1992, 1995; Asplund et desmopressin group, compared gestive heart failure (Abrams, al., 1998). A good response from with an increase of 21% (from 2.5 Mattiasson, Lose, & Robertson, treatment is a nocturnal urine out- to 2.9 hours) in the placebo group 2002). put of 350 to 450 ml, including (p < 0.001). Another study evalu- the volume of the void in the ated the effects of 12 months of Treatment of Nocturia Related morning and one, possibly two, treatment in adult men and To Low Bladder Capacity nocturnal micturition episodes. If women with the optimal dose of this goal is not achieved, then the desmopressin (0.1 mg, 0.2 mg or dose of desmopressin can be 0.4 mg) or placebo (Lose et al., Pharmacologic Treatment increased within one week. 2004). The mean duration of the Few clinical trials have Serum sodium concentration first sleep period gradually specifically evaluated the use of should be assessed before and increased in both men (from 157 medications for treating nocturia three to four days after starting minutes to 288 minutes) and by improving bladder capacity. desmopressin, as well as three to women (from 142 minutes to 310 While the evidence base for use four days after each increase in minutes) from baseline to 12 of antimuscarinic agents to treat dose. months. The feeling of being well nocturia has not been estab- rested in the morning and better lished, these drugs have been Efficacy of Desmopressin day time performance improved investigated in studies of over- The efficacy of desmopressin in parallel with the sleep active bladder (OAB) syndrome, in treating nocturia has been eval- improvement. At follow up one of which nocturia is a common uated in different populations, month after treatment had been symptom. including men, women, and older discontinued, the mean duration (Enablex®). The adults, in both short-term and of the first sleep period had effects of darifenacin on nocturia long-term studies (Cannon, Carter, decreased, confirming that the are variable. Improvements in & McConnell, 1999; Lose et al., increase was a treatment-related weekly nocturia episodes were 2003; Mattiasson, Abrams, van effect (Lose et al., 2004). observed in one 12-week, placebo- Kerrebroeck, Walter, & Weiss, controlled trial (Hill, Khullar, 2002; Rembratt, Norgaard, & Safety and Tolerability Wyndaele, Lheritier, & the Dari - Andersson, 2003). The greater the Of Desmopressin fenacin Study Group, 2006), severity of a disorder of the vaso- When treating nocturics with while no improvement was seen pressin system, the higher the desmopressin, it is important in another trial of similar duration sensitivity to desmopressin, and that excess fluid intake be avoid- (Haab, Stewart, & Dwyer, 2004). In substantial reductions in nocturia ed after the medication has been a pooled analysis of three phase

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III studies to evaluate the efficacy, OAB and nocturia achieved relief however, significantly reduce tolerability, and safety of darife- of night time voiding symptoms OAB-related and severe OAB- nacin, the decrease in number of when treated with and related nocturnal micturitions nocturnal awakenings per week if having nocturnal polyuria compared to placebo. No effect caused by OAB was greater with affected the response was per- was reported on non-OAB mic- darifenacin than placebo, al- formed using pooled data from turitions (Rackley et al., 2006). though the between-group differ- four phase III clinical trials. The A six-month, open-label trial ence was not statistically signifi- first analysis looked at reductions in 43 men with BPH-related cant. The median change from in nocturia episodes after treat- symptoms who failed alpha- baseline for darifenacin 7.5 mg ment with solifenacin (5 mg or 10 blocker therapy was conducted. was -1.7 vs. -0.8 for placebo and mg), and a second analysis was These men were treated with -1.9 for darifencacin 15 mg versus performed in patients with and ER 4 mg and demon- -1.1 for placebo (Chapple et al., without nocturnal polyuria. strated a reduction in nocturnal 2005). In a two-year, non-compar- Patients were considered to have voids from 4.1 episodes per night ative, open-label extension study nocturnal polyuria if their noctur- to 2.9 episodes per night (Kaplan, with darifenacin 7.5 mg and 15 nal urinary volume was greater Walmsley, & Te, 2005). mg, the median change in noctur- than the percentage of hours in IR and nal awakenings at 24 months was the day asleep multiplied by the XR (Sanctura®). A multi-center, -1.5 (14.3% change) (Haab et al., 24-hour urine volume (Weiss & placebo-controlled trial involving 2006). Blaivas, 2000). Statistically signif- 134 men and 389 women with (Toviaz®). In a icant reductions in nocturia OAB and urge incontinence was randomized, placebo-controlled, episodes were noted in patients conducted. The sample was ran- double-blind multi-center trial treated with solifenacin. Median domized to receive either trospi- performed in the United States reductions were -35.5% for 5 mg um chloride 20 mg twice a day comparing fesoterodine 4 mg or 8 solifenacin and -36.4% for 10 mg (BID) or placebo for 12 weeks. The mg to placebo, fesoterodine 4 mg solifenacin compared to -15% for trospium chloride-treated pa tients showed significant improvement placebo (p = 0.021 and p < 0.001, showed a statistically significant in mean change from baseline respectively). In addition, signifi- decrease in the average number of compared to placebo for the num- cantly more patients treated nocturnal voids after week four (p ber of nocturnal micturitions (p < with solifenacin versus placebo < 0.001) and week 12 (p < 0.05), 0.05). The mean percent change achieved a median nocturic fre- but not at week one (Zinner et al., from baseline for placebo was quency of one episode/night or 2004). -25.5%, for fesoterodine (4 mg) it fewer. Solifenacin reduced noc- An analysis using pooled data was -33.3%, and for fesoterodine turia episodes only in patients from two identically designed (8 mg) it was -25% (Nitti et al, without nocturnal polyuria. In phase III trials involving males 2007). Several other clinical trials those patients treated with solife- and females compared trospium with fesoterodine have demon- nacin without nocturnal polyuria, chloride extended release to strated a decrease in nocturnal more than 60% achieved an aver- placebo. A significantly greater voids/24 hours. However, when age of one nocturic episode night- mean reduction from baseline in compared to placebo, the differ- ly or fewer by the end of the study nocturnal voids (0.8 vs. -0.6, p = ence was not statistically significant (Brubaker & Fitzgerald, 2007). 0.006) was noted. Reductions in (Chapple et al., 2007; Dmochowski Tolterodine (Detrol®). The nocturnal voids were accompa- et al., 2010; Hesrchorn et al., 2009). efficacy and tolerability of night nied by significant improvements (Ditropan®). Pub - time tolterodine dosing on in sleep-related quality-of-life lished data are limited regarding urgency-related micturitions in domains (Ginsberg, Oefelein, & the efficacy of oxybutynin for noc- patients with OAB and nocturia Ellsworth, 2009). turia. In a placebo-controlled trial were assessed. In this study, A subgroup analysis of male investigating the effects of behav- changes in the number of night patients from two large, phase III, ioral and drug therapy on nocturia time and 24-hour micturitions double-blind, randomized, place- in older incontinent women, oxy- were analyzed using a 5-point bo-controlled studies evaluated butynin decreased nocturia epi - urgency rating scale for each mic- tropsium chloride extended re- sodes significantly more than turtition, ranging from no urgency lease versus placebo. A greater placebo, though these effects were to severe urgency and urgency decrease from baseline with tro- less than those observed with . Tolterodine spium chloride extended release behavioral modification (Johnson, ER was noted to decrease the total compared to placebo was noted Burgio, Redden, Wright, & Goode, number of nocturnal micturitions, for nocturnal voids (-0.9 vs. -0.5, p 2005). compared to placebo, though the < 0.05) (MacDiarmid, Ellsworth, Solifenacin (Vesicare®). An difference was not statistically Ginsberg, Oefelein, & Sussman, analysis of whether patients with significant. Tolterodine ER did, 2009).

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Nocturia and Benign Prostatic in nocturnal voids. Mean nocturia problem, and mixed nocturia) Hyperplasia (BPH) was reduced at one year by 0.35, allows for a tailored treatment reg- Variable results have been 0.40, 0.54, and 0.58 for placebo, imen. Use of a diagnostic and demonstrated for the effects of finasteride, , and com- treatment algorithm can help alpha blockers and 5-alpha- bination groups, respectively. direct clinical decision making in reductase inhibitors on nocturia Similar results were seen at one nursing practice. Although behav- in men with benign prostatic year and four years (Johnson et al., ioral and lifestyle changes may hyperplasia (BPH). In the VA 2007). The clinical impact of this help the overall population suffer- cooperative study program trial, change on quality of life was not ing from nocturia, an individual- 1978 men with BPH had baseline assessed. istic approach identifying and nocturia of 2.5 episodes per treating medical conditions that night. They were randomized to 5-Alpha-Reductase Inhibitors cause nocturia with appropriate receive (Hytrin®), finas- Little data are available pharmacologic therapies may teride (Proscar®), terazosin plus regarding the effect of 5-alpha- have a significant impact on noc- finasteride, or placebo. Nocturia reductase inhibitors on nocturia. turia. episodes decreased to around Two studies have demonstrated Desmopressin has been two per night for all groups, no effect of finasteride monother- demonstrated to be effective in including placebo. No significant apy on nocturia (Johnson et al., those individuals suffering from difference was found among any 2003, 2007). In a prospective, nocturnal polyuria. Some im - treatment arms, including place- multi-center, open-label study provement in nocturnal voids bo (Johnson et al., 2003). evaluating the effect of dutas- and nocturnal OAB-related voids In an observational study eval- teride 0.5 mg/day on the symp- has been demonstrated with var- uating an extended release formu- toms of BPH, a decrease from ious antimuscarinic agents. In lation of (Uroxatral®) 10 baseline at 12 weeks and 24 males suffering from bladder out- mg/day, 144 of the males had more weeks with respect to Q7 of the let obstruction secondary to BPH, than two nightly voids at the start International Prostate Symptom reduction in nocturnal voids has of the study, and 51.4% improved Score (IPPS) was noted. Q7 of the been demonstrated in clinical tri- to two nightly voids or fewer after IPPS refers to how many times a als with both alpha-adrenergic nine days of treatment. At three person most typically gets up to receptor blockers as well as 5- months on treatment, 60.4% had urinate from bedtime until getting alpha-reductase inhibitors. Cur- two nightly voids or fewer up in the morning. Significant rently, there are no pharmacolog- (Roehrborn, van Kerrebroeck, & reductions of -0.5 and -0.6 noctur- ic therapies approved by the Nordling, 2003). A pooled analy- nal voids were also noted at 12 Food and Drug Administration sis of three double-blind studies weeks (p < 0.001 for each) for the treatment of nocturia; noted alfuzosin improved noc- (Desgrandchamps, Droupy, Irani, however, two formulations of turia in patients with BPH (Saad Saussine, & Comenducci, 2006). desmopressin are currently in et al., 2005). In a long-term study, clinical trials. the occurrence of three or more Summary References nocturnal voiding episodes was Abrams, P., Cardozo, L., Fall, M., Griffiths, decreased by two-thirds after Nocturia is a prevalent and D., Rosier, P., Ulmsten, U., ... Wein, A. three months of therapy with alfu- bothersome symptom that has sig- (2003). The standardization of termi- zosin, with these results being nificant impact on health and nology in lower urinary tract func- maintained at two years (Elhilali quality of life. Terminology has tion: Report from the standardization now been adopted that allows sub-committee of the International et al., 2006). Continence Society. Urology, 61, 37. The effectiveness of single or health care providers across all Abrams, P., Mattiasson, A., Lose, G.R., & combination drug therapy on noc- specialties to “speak the same lan- Robertson, G.L. (2002). The role of turia in men with lower urinary guage” as it pertains to nocturia. desmopressin treatment in adult noc- This will greatly facilitate the turia. British Journal of Urology tract symptoms suggestive of BPH International, 90, 32-36. was analyzed. The analysis evaluation and subsequent man- Adam, P. (1997). Evaluation and manage- included 2583 men with at least agement of nocturia. The voiding ment of diabetes insipidus. American one nocturnal void per night who diary is the cornerstone to the Family Physician, 55, 2146-2153. evaluation of a patient presenting Appell, R.A., & Sand, P.K. (2008). were randomized to receive doxa- Nocturia: Etiology, diagnosis and ® with nocturia, and the history and zosin (Cardura ) alone, finasteride treatment. Neurourology and alone, combination therapy, or physical examination allow for Urodynamics, 27, 34-39. placebo, and were followed for at further evaluation of treatable Asplund, R. (1992). Micturition habits and least 12 months of the four-year causes of nocturia. Classifying diuresis in relation to sleep and well- nocturia into one of four cate- being in elderly subjects with empha- study period. Doxazosin alone sis on antidiuretic hormone (thesis). and combination therapy led to a gories (diurnal polyuria, noctur- Stockholm: Karolinksa Institute. statistically significant reduction nal polyuria, bladder storage

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Asplund, R. (1995). The nocturnal Coyne, K.S., Zhou, Z., Bhattacharyya, S.K., of Pelvic Floor Dysfunction, 17, 239- polyuria syndrome (NPS). General Thompson, C.L., Dhawan, R., & Versi, 247. Pharmacology, 26, 1203-1209. E. (2003). The prevalence of nocturia Irwin, M., McClintick, H., Costlow, C., Asplund, R. (1999). Mortality in the elder- and its effect on health-related quali- Fortner, M., White, J., & Gillin, J.C. ly in relation to nocturnal micturi- ty of life and sleep in a community (1996). Partial night sleep deprivation tion. British Journal of Urology sample in the USA. British Journal of reduces natural killer and cellular International, 84(3), 297-301. Urology International, 92(9), 948-954. immune responses in humans. The Asplund, R. (2003). Nocturia in relation to Cvetkovic, R.S., & Plosker, G.L. (2005). Federation of American Societies for sleep, somatic and medical Desmopressin: in adults with noc- Experimental Biology, 10, 643-653. treatment in the elderly. 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Section Meeting of the AUA, Las Meeting, Finland, August 2000. lationships between occurrence, age, Vegas, 2009. Reynard, J.M., Cannon, A., Yang, Q., & and perceived impact. British Journal Marschall-Kehrel, D. (2004). Update on noc- Abrams, P. (1998). A novel therapy for General Practice, 49(448), 897-900. turia: The best of rest is sleep. Urology, nocturnal polyuria: A double- blind van Balen, R., Steyerberg, E.W., Polder, J.J., 64, 21-24. randomized trial of frusemide against Ribbers, T.L., Habbema, J.D., & Cools, Mattiasson, A., Abrams, P., van Kerrebroeck, placebo. British Journal of Urology, 81, H.J. (2001). Hip fracture in elderly P., Walter, S., & Weiss, J. (2002). 215-218. patients: Outcomes for function, quali- Efficacy of desmopressin in the treat- Rittig, S., Jensen, A.R., Jensen, K.T., & ty of life, and type of residence. ment of nocturia: A double-blind Pederson, E.B. (1998). 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Lower urinary tract Yoshimura, K., Terada, M., Matsui, Y., Terai, Archives Internal Medicine, 156, 545- symptoms: What are the implications A., Kinukawa, N., & Arai, Y. (2004). 550. for patients? European Urology, 40, 12- Prevalence of and risk factors for noc- Rackley, R., Weiss, J.P., Rovner, E.S., Wang, 20. turia: Analysis of a health screening J.T., Guan, Z., & the 037 Study Group. Schatzl, G., Temml, C., Schmidbauer, J., program. International Journal of (2006). Nighttime dosing with toltero- Dolezal, B., Haidinger, G., & Urology, 11, 282-287. dine reduces overactive bladder-relat- Madersbacher, S. (2000). Cross- sec- Zinner, N., Gittelman, M., Harris, R., Susset, ed nocturnal micturitions in patients tional study of nocturia in both sexes: J., Kanelos, A., Auerbach, S., & the with overactive bladder and nocturia. Analysis of a voluntary health screen- Trospium Study Group. (2004). Urology, 67(4), 731-736. ing project. Urology, 56, 71-75. Trospium chloride improves overac- Rembratt, A., Graugaard-Jensen, C. Stember, D.S., Weiss, J.P., Lee, C.L., & tive bladder symptoms: A multicenter Senderovitz, T., Norgaard, J.P., & Blaivas, J.G. (2007). Nocturia in men. phase III trial. Journal of Urology, 171, Djurhuus, J.C. (2004). Pharmaco- kinet- International Journal of Clinical 2311-2315. ics and pharmacodynamics of desmo- Practice, 61(Suppl., 155), 17-22. pressin administered orally versus Stewart, R.B., Moore, M.T., May, F.E., Marks, Additional Reading intravenously at daytime versus night- R.G., & Hale, W.E. (1992). Nocturia: A Weiss, J.P., Blaivas, J.G., Stember, D.S., & time in healthy men aged 55-70 years. risk factor for falls in the elderly. Chaikin, D.C. (1999). Evaluation of European Journal of Clinical Journal of the American Geriatric nocturia in men: The nocturia and noc- Pharmacology, 60, 397-402. Society, 40, 1217-1220. turnal bladder capacity indices. Rembratt, A., Norgaard, J.P., & Andersson, Swithinbank L.V., Donovan J.L., duHeaume Neurourology and Urodynamics, 18, K.E. (2003). Desmopressin in elderly J.C., Rogers C.A., James M.C., Yang Q., 559-565. patients with nocturia: Short-term safe- & Abrams, P. (1999). Urinary symp- ty and effects on urine output, sleep toms and incontinence in women: Re- and voiding patterns. British Journal of Urology International, 91, 642-646. Rembratt, A., Riis, A., & Norgaard, J.P. (2006). Desmopressin treatment in Urologic Nursing Editorial Board Statements of Disclosure nocturia: An analysis of risk factors for hyponatremia. Neurourology and In accordance with ANCC-COA governing rules Urologic Nursing Editorial Board state- Urodynamics, 25, 105-109. ments of disclosure are published with each CNE offering. The statements of disclosure for Rembratt, A., Robertson, G.L., Norgaard, J.P., this offering are published below. & Andersson, K.E. (2000). Pathogenic Susanne A. Quallich, ANP-BC, NP-C, CUNP, disclosed that she is on the Consultants’ aspects of nocturia in the elderly: Bureau for Coloplast. Differences between nocturics and nonnocturics. Presentation at the 30th All other Urologic Nursing Editorial Board members reported no actual or potential con- International Continence Society flict of interest in relation to this continuing nursing education article.

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