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Home , Enterocele, Pelvic organ prolapse, Pessary, Vaginal evisceration

SERIES

Pessary Care: Follow Up and Management of Complications

Katharine O’Dell and Shanna Atnip ESSARIES

P ven after a successful pes- sary fitting, a woman’s © 2012 Society of Urologic Nurses and Associates level of satisfaction and O’Dell, K., & Atnip, S. (2012). care: Follow up and management of com- duration of pessary use plications. Urologic Nursing, 32(3), 126-137, 145. Eare difficult to predict. In one qualitative study, successful pes- Successful use of vaginal support requires provider and patient under- ERIES ON sary use was described by partic- standing of expected symptom-relief, potential complications, self-care options, S and evaluation and treatment of pessary-related problems. This second article in ipants as a learning process, lead- a three-part series summarizes clinical recommendations and evidence related ing to increasing comfort and to pessary management. confidence (Storey, Ashton, Price, Irving, & Hemmens, 2009). Key Words: Pelvic organ , pessary, therapy, complications. PECIAL Women initially reported feel- S ings of isolation and embarrass- Objectives: ment about pessary use. How- 1. Describe complications that may arise in women who use pessaries. ever, through encouraging inter- actions with providers, most 2. Explain the course of pessary follow up, including instructions, intervals between office visits, and pessary surveillance. commonly the office nursing staff, positive attitudes toward 3. Discuss pessary management and prevention of pessary-related complica- wearing a pessary developed tions. during follow up, and visits became anticipated social out- Duration of Pessary Use ings for several users (Storey et The first article in this series al, 2009). (Atnip & O’Dell, 2012) discussed Because women use pessaries clinical issues related to initiating for different reasons (for example, support pessary use, including a to totally avoid or defer ), Katharine O’Dell, PhD, CNM, WHNP-BC, summary of evidence related to is an Assistant Professor of OB/GYN, the patient and pessary selection, and duration of pessary use can be Division of Pelvic Medicine and Re - the likelihood of symptom relief. expected to vary. Reported use constructive Surgery, UMass Memorial continuation rates range from Medical Center, Worcester, MA. This article summarizes evidence related to pessary use, follow up, 56% to 70% in up to three years Shanna Atnip, MSN, WHNP-BC, is a Nurse and complications; describes cur- of follow up (Clemons, Aguilar, Practitioner, the Division of rent recommendations for clini- Sokol, Jackson, & Myers, 2004; and Reconstructive Pelvic Surgery, Komesu et al., 2007). One long- Parkland Health & Hospital System, and the cal practice where data are not University of Texas Southwestern Medical available; and identifies potential term follow-up study concluded Center, Dallas TX. areas for future research. that women are more likely to

Note: Objectives and CNE Evaluation Form appear on page 137. Urologic Nursing Editorial Board Statements of Disclosure Statement of Disclosure: The authors In accordance with ANCC-COA governing rules Urologic Nursing Editorial Board state- reported no actual or potential conflict of ments of disclosure are published with each CNE offering. The statements of disclosure for interest in relation to this continuing nursing this offering are published below. education activity. Susanne A. Quallich, ANP-BC, NP-C, CUNP, disclosed that she is on the Consultants’ This learning activity was partially funded Bureau for Coloplast. by an unrestricted educational grant from All other Urologic Nursing Editorial Board members reported no actual or potential CooperSurgical, Inc. conflict of interest in relation to this continuing nursing education activity.

126 UROLOGIC NURSING / May-June 2012 / Volume 32 Number 3 continue pessary use if they are moval, bowel perforation and Bump, & Addison, 2000; Gorti, over 65 years or have comorbidi- sepsis, and uremia, urosepsis, Hudelist, & Simons, 2009; Pott- ties that increase surgical risk and/or kidney damage due to Grinstein & Newcomer, 2001). (Clemons, Aguilar, Sokol et al., and/or obstruction The following sections discuss 2004). In a case series of women (Arias, Ridgeway, & Barber, 2008). common self-care and provider seeing a single provider in Although these cases repre- care options. Australia (n = 273), 60% contin- sent severe morbidity and occa- ued pessary use for four weeks, sional mortality, only 39 of these Initial Instructions while 14% were continuing major complications were re- New pessary users are gener- users over an average follow up ported during a period of more ally instructed to note improve- of seven years (range: 2 to 14 than 50 years. Most cases oc - ment in symptoms and report S years) (Sarma, Ying, & Moore, curred in women with neglected new problems, such as or PECIAL 2009). During their period of fol- or forgotten pessaries, though discomfort, genital bleeding, low up, 44% of initial pessary two cases of vesicovaginal abnormal , sex- users opted to return to no inter- occurred in older adult women ual problems, and problems with vention, and 30% proceeded to who were obtaining regular care. elimination of urine or stool S surgery. These findings confirm The first was discovered two (Atnip, 2009). Optimal intervals ON ERIES that some, though not all, women hours after initial insertion of a for self-care have not been deter- can expect to experience an Ring pessary, suggesting a possi- mined, and recommendations extended period of satisfactory ble pre-existing, unidentified vary. For example, one pessary pessary use. vaginal wall abnormality. The manufacturer’s packet instruc-

second occurred in a woman tion states that in ideal circum- P

using a Gehrung (arch) pessary stances, users should be taught to ESSARIES Potential Complications During over a 12-year period. During remove all styles of pessary Pessary Use that time, she reportedly per- nightly for cleaning and reinser- The importance of on-going, formed daily self-removal, clean- tion (CooperSurgical, 2008). regular re-evaluation, even for ing, and re-insertion, and attend- Optional daily removal and women who are comfortable and ed regular follow-up visits. The cleaning are encouraged during asymptomatic during pessary latter case reminds providers the use of some pessaries, and use, must be emphasized to all and pessary-users that occasion- referred to as mandatory during providers and users. Because al serious complications may use of latex inflatable and Cube there is no centralized reporting occur even with the most dili- pessaries, the latter without refer- option, true pessary complica- gent care. ence to the presence or absence tion incidence is not known. Finally, in a recent case of drainage holes. In the 14-year follow-up of report, an 82-year-old woman For the newer silicone inflat- Australian Ring pessary users, experienced able pessary, manufacturer rec- 56% reportedly had some type of during initial fitting, causing dis- ommendations suggest removal complication, including genital placement of the pessary into the for cleansing every day or two bleeding, involuntary pessary abdomen, with resultant emer- (Panpac Medical Corporation, expulsion, unusual vaginal dis- gency (Rubin, Jones, 2010). When pessaries are re- charge, pain, and & Harmanli, 2010). While the moved, they can be washed with (Sarma et al., 2009). Un- scarcity of reports suggests an soap and water, rinsed thorough- fortunately, this study design overall low-risk of serious pes- ly, and re-inserted, or stored for does not help women compare sary complications, these publi- future use. While providers may risks of pessary use with risks of cations highlight the need for offer women optional teaching untreated prolapse. careful assessment prior to pes- related to self-removal and re- While mild and/or transient sary placement at each routine insertion, some may not be either symptoms appear to be fairly visit and whenever new symp- able or willing to perform self- common during pessary use, rare toms occur. care (Sarma et al., 2009). serious adverse effects can also In addition, women initiat- occur, particularly if pessary ing pessary use are likely to have Pessary Follow Up care is neglected. In a review of many questions related to how individual case studies pub- While it seems clear that reg- pessary use may affect their lished between 1950 and 2007, ular pessary follow up is impor- lifestyle and activities. Some serious adverse events related to tant, both appropriate intervals answers will require experience. pessary use included vesicovagi- for follow-up and interim self- For example, women who are of nal and rectovaginal , care recommendations continue reproductive age may need to impaction or entrapment of the to be largely based on expert experiment to identify their pref- pessary requiring surgical re- opinion (Cundiff, Weidner, Visco, erence for management of their

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Table 1. urine or stool likely to be reasons Self-Care Options for Women Using Vaginal Support Pessaries for emergent care. Recommendations for appro- Removal Intervals Between Visits: priate routine intervals for follow • Regularly (nightly, weekly, monthly) and re-insert post-cleansing up of women reporting comfort- • Regularly removed and leave out overnight able, effective pessary use also • Occasionally out (for intercourse, cleaning, temporary discomfort) vary, typically based on expert • Occasionally in (for increased activity or sporting event, as with opinion. For example, one manu- incontinence pessary) facturer’s product insert for a Pessary Cleaning variety of pessary types instructs providers to require women to • Remove, wash with soap and water, rinse, and re-insert return within 24 hours of initial Genital Cleansing fitting, again in 72 hours, and every few months, with schedule • With pessary in place, cleanse external genitals only with bath or shower variations based on clinical judg-

ESSARIES • With pessary in place, insert acidifying , , or prescribed medication ment (Cooper Surgical, 2008).

P • With pessary removed, insert acidifying douche, gel, or prescribed medication Another manufacturer’s package Enhancing Regular Follow Up insert for the Inflatable Donut pessary also provides a mix of • Develop an informed consent for patients to sign; retain a copy and give a very specific recommendations copy to the patient (for example, the device can only • Schedule follow-up visits before the patient leaves the office ERIES ON • Suggest use of a Med-alert bracelet for cognitively impaired women as a be prescribed by a physician, and S reminder to care providers fitting should be followed within 24 to 48 hours to rule out allergy to the product) with instructions that are more vague (for example,

PECIAL menses, either by pessary re - facturer. Finally, women often subsequent follow-up visits can

S moval through the entire menses, have questions about the implica- be planned to fit the needs of or by more frequent removal and tion of pessary use for security the patient) (Panpac Medical reinsertion after cleaning. As surveillance. While metal detec- Corporation, 2010). This review noted in the first article of this tors will not respond to silicone- of manufacturer concerns sug- series (Atnip & O’Dell, 2012), only pessaries, newer surveil- gests that allergic reactions to some pessaries, such as the Ring, lance technologies, including full- pessaries may have occurred, are expected to be more compati- body scanning, are likely to identi- and inclusion of the risk may be ble with use during intercourse; fy a pessary in place. Although the needed in informed consent dis- however, couples’ preferences utility is unclear, some clinicians cussions, even though cases have may vary. Well-fit pessaries are provide women with confirmation not appeared in the medical liter- expected to allow women to per- of pessary use via brochure, written ature. form a full range of physical prescription, or form letter on prac- When providers make fol- activities and exercise comfort- tice letterhead to help preclude low-up decisions that deviate ably, but experience may identify potential delay or embarrassment from manufacturers’ recommen- extreme activities that are not (Bradway, 2011). Table 1 presents dations, decisions should be pessary-compatible for an indi- additional provider-generated self- based on available evidence. vidual. Women may also express care options for women who use However, there is a dearth of concern about pessary use during pessaries. interval comparison trials. In medical testing, such as observational follow up, 104 colonoscopy and diagnostic Intervals Between Office women were successfully fitted imaging. Because preferences Follow Up with Ring pessaries with or with- may vary, women may be best Regardless of the follow-up out support membrane, and six advised to query the provider plan, if pessary users report with Cube pessaries, with the performing the endoscopic pro- warning symptoms between reg- presence or absence of drainage cedure or imaging regarding the ular return visits, they will need holes not reported (Wu, Farrell, need for pessary removal. to be triaged to emergent or Baskett, & Flowerdew, 1997). Women planning Magnetic urgent care related to the severity These women were followed ini- Resonance Imaging can usually be of symptoms. Triage options have tially at two weeks post-fitting, reassured that silicone pessaries not been well studied. Clinical then every three months for the do not include metal; however, judgment related to symptom first year, and every six months confirmation of this should be severity must be used with pain, thereafter in the absence of ero- sought through the pessary manu- bleeding, and acute retention of sion. The authors concluded that

128 UROLOGIC NURSING / May-June 2012 / Volume 32 Number 3 SERIES participants had no serious com- Table 2. plications, although 15 women Components of a Return Pessary Visit developed vaginal abrasions (all using Ring pessaries), eight Focused History of Interim Changes in Systemic and Pelvic Status developed vaginal erosions (five • Lower urinary tract symptoms with Cube pessaries and three • Bowel status with Rings, p < 0.001), and 10 • Abnormal discharge/bleeding/odor reported (three Cube- • Pelvic pressure/pain users and seven Ring-users). • Vaginal bulge beyond pessary Complication management was • Sexuality issues • Current self-care regimen not addressed in the Wu et al. S • Medication changes (1997) publication. PECIAL • Social changes (caregiver status, employment, exercise or weight management In a subsequent survey of regimens, new sexual partner) pessary providers, the most com- mon follow-up interval pattern Targeted Physical Examination was one week, one month, and • Regional lymphadenopathy or rashes S every three months thereafter, • Abdominal tenderness or masses ON ERIES with no variation specified relat- • External genital examination ed to type of pessary (Pott- Routine Pessary Care Grinstein & Newcomer, 2001). Standard practice recommenda- • Pessary removal and cleaning • Inspection for vaginal or cervical irritation or erosion tions are also published as inci- P • Replacement of stained or damaged pessary dental elements of broader dis- ESSARIES cussions. One case discussion Other Components Based on Findings suggests office-visit intervals varying from three to six months, • Vaginal microscopy (irritation, increased discharge or odor) with closer intervals for pessaries • Vaginal irrigation (suspected ) that are self-retaining or lack • Urinalysis (dysuria, change in continence status) drainage holes (Kaaki & Mahajan, 2007). Responding to a survey in the United Kingdom, providers aid difficult removals include clud ing the anterior vaginal wall, also reported intervals between tenaculum or Ring forceps, pes- cervical fornices, or pessary visits ranging from 3 to sary removers, or dental floss post-) is important 12 months with low complica- tied to the pessary as a loop prior for identifying mechanical injury tion rates, although patient char- to insertion. Tips for removal of of the vaginal epithelium. Typi- acteristics, self-care practice, and different shapes of pessaries are cal areas of injury that may result pessary type were not ascer- summarized in Table 3. from different styles of pessary tained (Gorti et al., 2009). These Once the pessary has been are illustrated in Figure 2. reports support the practice of removed, an appropriately sized Vaginal cleansing at pessary longer intervals between pessary vaginal speculum is used to aid follow-up visits or during routine removal and cleaning as safe, careful inspection of the vaginal self-care is not universally per- standard, and cost-effective care. epithelium for mechanical irrita- formed, and there is currently no tion (Kaaki & Mahajan, 2007). A evidence to support routine irriga- Pessary Surveillance proctology swab or other dis- tion. If excessive discharge is In the absence of a definitive placement device can be used to observed in the absence of identi- evidence base comparing surveil- increase visualization of cervical fiable pathogens, the can lance practices, standards of care fornices or the vaginal apex (see be cleansed in a variety of ways. at pessary return visits also rely Figure 1). Following complete One cleansing option is wiping of on expert opinion. These visits hysterectomy, the vaginal apex the vagina with a proctology swab generally include some combina- may be as thin as 2 to 4 mm moistened with water, saline, tion of focused history, pessary (Tulikangas, Walters, Brainard, & vaginal water-based lubricant, or a removal and cleaning, and vagi- Weber, 2001), increasing the risk mild antiseptic prepared nal inspection, with or without of life-threatening erosion into with diluted povidone-iodine or irrigation or topical treatment the peritoneum. Careful manipu- chlorhexidine gluconate. Similar (Atnip, 2009). Components of a lation of any folds of redundant may also be used for typical interim-focused history vaginal tissue, especially of areas vaginal lavage using a 10 to 60 cc are listed in Table 2. that may be more difficult to with size choice based on Removal techniques also visualize in standard lithotomy clinical determination of vaginal remain unstudied. Suggestions to or semi-Fowler’s position (in- diameter (Atnip, 2009). Lavage

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Table 3. fluid can be contained using Tips for Providers at Return Visits waterproof pads, toweling, and/or a collection vessel, such as an Lubricate the vaginal introitus for pessary removal. emesis basin. Clinicians should take care if Draw pessary down toward introitus for easier removal using a Ring forceps, vaginal cleansing products are tenaculum, the manufacturer’s loop, or an added loop of waxed dental tape. used. Both chlorhexidine and Consider 2% lidocaine gel application to the introitus 5 minutes prior to removal povidone-iodine have been stud- for women who report extreme sensitivity. ied for pre-operative and obstetric vaginal use in attempts to de - Consider ongoing treatment with vaginal estrogen if superficial fissures occur crease wound infection. While with pessary removal. chlorhexidine (4%) has been If lavage is indicated, collect water with towels/emesis basin; ask patient to identified as more effective than cough to expel residual before pessary reinsertion. povidone-iodine (10%) in reduc- ing vaginal wall bacteria within

ESSARIES Slight changes in pessary color and odor are common. five minutes (Vorherr, Vorherr, P Options to aid self-removal: Mehta, Ulrich, & Messer, 1984), this may not translate to de- • Add a dental tape loop. creased infection risk (Webster & • Try different positions (standing with foot on chair, lying back in Osborne, 2007), is off-label use Semi-Fowler’s, seated on toilet). (Van Wicklin, 2006), and may • Valsalva or cough during removal.

ERIES ON result in significant irritation, • Lubricate the vaginal opening again for reinsertion. S including acute desquamation of • Gently tilt or cork screw pessary diagonally to increase opening diameter and avoid sensitive urethral area. the vaginal epithelium (Shippey & • Try careful use of a pessary remover device (generally recommended for Malan, 2004). To avoid this risk, provider use only). providers may prefer to perform

PECIAL any pessary-related vaginal cleans-

S ing with simple saline or water and treat identified microbial Figure 1. as discussed below. Proctology Swab Used in Examination of Mechanical Vaginal Erosion Prevention of Pessary-Related Complications Although providers often advise routine use of vaginal products in conjunction with pessary use, the relative costs, preventive role, and comparative outcomes of these products have not been well-studied. Current evidence related to the role of three strategies is summarized below, including topical estrogen treatment of urogenital atrophy, vaginal moisturizers, and vaginal acidification. Vaginal Estrogens Urogenital atrophy due to low estrogen levels results in thinning of the epithelial lining, loss of elasticity, contraction of the introitus, and dryness due to decreased vascularity and tran- sudate (Freedman, 2008). Factors that contribute to urogenital atro- phy include post-menopausal status, (which increases

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Figure 2. estrogen metabolism), and use of Mechanical Injury from A) Ring, B) Gellhorn, and C) Cube Pessaries certain medications and breast cancer treatments, such as some selective estrogen receptor mod- ulators (Al-Baghdadi & Ewies, 2009). Atrophic changes can result in increased discomfort or tissue injury with pessary inser- tion and removal, and have been associated with higher rates of

mechanical vaginal erosion dur- S

ing pessary use (Arias et al., PECIAL 2008). It may be possible to mod- ify problems related to pessary use in the presence of vaginal

atrophy by modifying reversible S

risks (such as through smoking ON ERIES cessation). In the absence of com- parative evidence, provider pre- scription of vaginal estrogen con- tinues to vary and includes use

prior to initial pessary fitting as P

needed during ongoing pessary ESSARIES Table 4. follow up and/or continuously Options Approved by the FDA for Treatment of Moderate to Severe throughout pessary use (Arias et Vaginal Atrophy Using Vaginally Placed Estrogen al., 2008; Sarma et al., 2009). Estrogens used vaginally are Generic Estrogen more effective than systemic (Trade Name)* Dose* Use Instructions estrogens in relieving symptoms Estradiol (Estrace®) 0.1 mg/gram Use measured applicator. of urogenital atrophy (North Initial: 2 to 4 grams daily for 1 to 2 American Society weeks. Gradually reduce to 1 to 2 [NAMS], 2010). Vaginally ap - grams for 1 to 2 weeks. plied estrogen relieves vulvo- vaginal symptoms by promoting Maintenance: 1 gram one to three times epithelial cell growth and cellular a week; adjust dose as needed to control symptoms. maturation, fostering re-coloniza- tion with normal lactobacilli, Note: Attempt to taper or discontinue at enhancing vaginal blood flow, 3 to 6 month intervals. decreasing vaginal pH to pre- Conjugated equine 0.625 Initial: 0.5 gram daily for 21 days; off for menopausal levels, increasing estrogen mg/gram 7 days. May increase to 2 grams based vaginal wall thickness and elastic- (Premarin®) on clinical response. ity, and improving sexual re- sponse (Freedman, 2008). For : 0.5 grams twice a week continuously. Several options for low-dose or ultra-low-dose vaginal estro- Estradiol (Vagifem®) 10 mcg Insert to upper vagina using applicator. gen therapy are available and Initial: Once daily for 2 weeks. listed in Table 4. It is important for women to understand that Maintenance: Twice weekly. estrogens used vaginally do not Adjust dose as needed to control offer the same risks and benefits symptoms, attempt to taper or as systemic hormone therapy. discontinue periodically. For example, while topical estro-

® gen use can improve dyspareu- Estradiol (Estring ) 0.0075 mg/ Insert into the upper third of the vagina nia, recurrent urinary tract infec- 24 hours for 90 days, then remove. tion (UTI), and urinary urgency, Replace for additional therapy; attempt low doses do not improve vaso- to taper or discontinue at 3 to 6 month motor symptoms or osteoporosis, intervals. or affect breast cancer risk (NAMS, 2010). Source: Micromedex Healthcare Series, 2011.

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In addition, concomitant use reproductive age, vaginal acidifi- the product as non-perfumed, of progestogens is not required for cation has not been shown to and compatible with latex and endometrial protection in women decrease the risk of pathogenic silicone pessaries. The gel with intact uteri, although surveil- bacterial overgrowth (Holley, appears to be a low-risk interven- lance to confirm this recommen- Richter, Varner, Pair, & Schwebke, tion, which may im prove tempo- dation during intermittent use or 2004). Outcomes related to rary lubrication, comfort, and for use longer than 12 months is vaginal acidification in post- pessary satisfaction for sympto- still not available (NAMS, 2010). menopausal women are even less matic women who prefer a non- Although bioidentical hor- well studied. hormonal choice. mones (those that are chemically When vaginal acidification is identical to ovarian estrogens) are part of the follow-up plan, two Vaginal Moisturizers increasingly marketed, there is no options include douching with Vaginal moisturizers have evidence to support claims of vinegar and water, and using an also not been widely studied with their enhanced safety or efficacy acidifying gel. Generally, vaginal pessary use but offer another over- (NAMS, 2010). douching remains contra-indicat- the-counter option to counter-act

ESSARIES Generally, the lowest effec- ed in pre-menopausal women symptoms associated with atro- P tive estrogen dose needed to because of concerns of altered phic vaginal changes. Unlike decrease symptoms is recom- vaginal flora and increased risk more temporary vaginal lubri- mended (NAMS, 2010). One new of vaginal and upper genital tract cants, they affect epithelial cells option, an ultra-low-dose vaginal infections (Cottrell, 2010). These directly. For example, some mois- containing 10 micrograms concerns may have little applica- turizers contain the negatively

ERIES ON of estrogen, has been shown to tion to post-menopausal pessary charged polymer,

S result in serum estradiol levels users with atrophy-related ab- polycarbophil (Fiorilli, Molteni, that are 50% lower than prior sence of normal vaginal flora, or & Milani, 2005). This polymer 25 microgram vaginal tablets to women who have undergone has both acidifying and water- (Eugster-Hausmann, Waitsinger, & hysterectomy and/or bilateral carrying qualities, and adheres to

PECIAL Lehnick, 2010). However, because salpingo-. In those the superficial cells of the vaginal

S ultra-low-dose products have not cases, clinicians may be best epithelial tissue until they are been tested in pessary users, it is advised to review potential risks normally shed in two to three not yet clear if they provide suffi- and benefits, allow women to days. This adherence is thought cient estrogenic effect to improve make their own choice and help to temporarily increase intracel- comfort or decrease complica- them evaluate their individual lular electrolyte and water vol- tions during pessary use, or what symptom outcomes during sub- ume, and may have a vasodilating the optimum dose interval and sequent visits. If douching is cho- effect, increasing blood flow. duration will be. sen because optimal solutions, Polycarbophil products have intervals, and outcome expecta- been shown to lower vaginal pH, Vaginal Acidification tions are understudied, specific improving signs of bacterial over- The normal vaginal pH in practice is based on expert opin- growth seen with bacterial vagin - women who are of reproductive ion and preferences of the indi- osis (Fiorilli et al., 2005; Wu, age is typically 3.5 to 4.5 but rises vidual pessary user. One suggest- Fielding, & Fiscella, 2007). On the to greater than 4.5 within 12 ed option involves weekly use of other hand, non-polymer-based months of becoming hypoestro- a solution of one-fourth cup of moisturizers, such as those with genic (Freedman, 2008). This vinegar mixed in one cup of a pectin base, may offer similar alkaline environment is thought warm water (Atnip, 2009). temporary symptom relief (Caswell to be a risk factor for atypical bac- A non-prescription acidifying & Kane, 2002). In comparison tri- terial over-growth. Some women gel recommended to pessary users als with estrogen-products, poly- report increased discharge or odor contains triethanolamine, hydroxy - carbophil-based moisturizers pro- during pessary use, and acidifica- quinolone sulfate, and sodium vided only transient symptom tion of the vagina has been sug- lauryl sulfate in a glycerin base improvement, and did not pro- gested as a potential deterrent or (Trimosan™) (CooperSurgical, vide the sustained subjective and remedy. One pessary manufactur- 2006). It is recommended for use objective changes seen with the er in cludes an acidifying gel for two to three times per week, use of vaginal estrogen products use with all their pessaries reportedly to adjust and maintain (Biglia et al., 2010). With regular (CooperSurgical, 2006). While a vaginal pH of 4.0, and lubricate use, vaginal moisturizers may some pessary users report a posi- the vaginal walls, reducing odor- limit vaginal discharge, odor, and tive clinical response to vaginal causing bacteria (CooperSurgical, dyspareunia for pessary users, acidification, there appears to be 2008). While no specific support- but are unlikely to prevent ongo- little data to support a universal ive references are provided, the ing atrophic change or associated recommendation. In woman of pessary manufacturer describes mechanical irritation and ero-

132 UROLOGIC NURSING / May-June 2012 / Volume 32 Number 3 SERIES sion. Pending conclusive data, Table 5. helping women extrapolate re- Clinical Management Options for Common search results such as these may Pessary-Related Problems also help them evaluate the costs and benefits of various self-care Symptom or Sign Management Options products. Increased pelvic Pessary removal, with re-fitting, or decision to proceed pressure, pain, or to alternate treatment (observation or surgery). obstruction of Management of Pessary elimination Complications (urine or feces)

Complications can occur Bleeding, mechanical Evaluate need for . S even in women who initially PECIAL irritation, or erosion of Consider initiation of vaginal estrogen use if report satisfactory pessary-relat- the vaginal epithelium appropriate. ed symptom relief and comfort. Problems may present as genital Consider biopsy of erosions or lesions that persist despite intervention. bleeding, unusual vaginal dis- S charge, pain or pressure, and/or AND ON ERIES defecatory complaints, or may Remove pessary and re-evaluate in 2 to 4 weeks. only be identified on routine OR vaginal examination (Sarma et al., 2009; Wu et al., 1997). Some Remove pessary and re-fit with alternate shape or size of pessary to moderate points of pressure.

pelvic symptoms, including con- P stipation, urinary frequency, Vaginal odor or Rule out erosion. ESSARIES dysuria due to UTI, and incom- unusual discharge Decrease intervals between pessary removal and plete or difficult bladder empty- cleansing. ing, are also common in post- Acidify the vagina (using appropriate vaginal menopausal women without pes- moisturizers or topical estrogen). saries, and the relative rate of Treat any identified specific vaginal infection. symptoms in users and non-users is not well studied. Although Consider replacing or sterilizing pessary. management of these common problems is beyond the scope of this article, when they occur in pessary users, the pessary’s common pessary-related prob- epithelial abrasion when com- potential role as an aggravating lems – mechanical injury of the pared to the other two groups or mitigating factor should be vaginal epithelium and abnormal (range = 0% to 18%; p ≤ 0.05), carefully evaluated. In addition, discharge – is presented in greater and abrasion occurrence was all clinicians providing pessary depth below. more common in Cube versus care must consider their own Ring pessary users (83% versus knowledge base and scope of Mechanical Injury of the 3%, p ≤ 0.001). There was no cor- practice, the resources available Vaginal Epithelium relation related to oral estrogen in their office setting, and the Vaginal inspection at regular use. These findings support cur- general health or frailty of each visits detects early signs of signif- rent recommendations for more pessary user in deciding which icant mechanical injury, allowing frequent return visits for users of complications to manage and for alterations in the clinical plan self-retaining pessaries (such as which to refer to specialty care. to avoid serious sequelae, such as Cubes) and for the use of vaginal Generally, when clinical assess- fistula formation. To determine estrogens for treatment of atro- ment of any complication sug gests which women were at higher risk phy. pessary use as an etiology, manage- of mechanical epithelial injury, Description and management ment options include refitting for Wu and colleagues (1997) as- of epithelial pressure injury has pessary size and shape, temporary signed study participants to visu- not been as well studied as cuta- or permanent removal of the pes- ally determine categories using neous pressure wounds (National sary, treatment of any active infec- assessment criteria not extrapo- Pressure Ulcer Advisory Panel, tion, and/or modifying the vaginal lated in the text. Women were 2010). When mechanical erosion environment with acidifying prod- described as having epithelium is identified, follow-up planning ucts or vaginal estrogen. Table 5 that was normal thickness (n = is based on clinical factors (such describes general clinical sugges- 14), moderate thickness (n = 28), as the location and depth of the tions for common pessary-related or atrophic (n = 33). Atrophic tis- injury related to fistula risk, fri- problems. Management of two sue was more likely to develop ability and use of anticoagulants

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related to bleeding risk, degree of prolapse might be mitigated Management strategies for atrophy and potential benefits of through use of intermittent sup- abnormal discharge in pessary vaginal estrogen use, evidence of port of the anterior vaginal wall users may include a variety of treatable infection, and risk of co- digitally or with a device such as options: the woman can opt for existing pathology, such as can- a proctology swab, which can temporary or permanent removal cers of the vagina, , or straighten the and allow of the pessary; pessary drainage ) (Kaaki & Mahajan, voiding. If this is unsuccessful, holes can be added to limit pool- 2007; Kenton, 2003). Temporary intermittent self-catheterization ing of vaginal exudate, a potential pessary removal to eliminate or temporary use of an in - medium for growth of odor-pro- mechanical pressure is often rec- dwelling urinary catheter may be ducing micro-organisms; atrophy ommended (Wu et al., 1997). necessary. or vaginal infections can be treat- Typical practice then includes a When erosions do not ed; or acidifying products may be recheck in two to four weeks, resolve within one month, biop- used (see also “Vaginal Acidi- depending upon the extent of the sy is indicated because occasion- fication” and “Vaginal Moisturi- epithelial injury (Atnip, 2009; al cases of vaginal and cervical zers” sections above). If an over-

ESSARIES Sarma et al., 2009). During that cancer in pessary users have growth of yeast or bacterial P time, any exposed vaginal been reported (Schraub et al., pathogens is suspected, treat- epithelium is typically protected 1992). In addition, recurring or ment options include the use of from dryness and chaffing on poorly healing mechanical injur- antimicrobials in regimens extra- clothing or pads. Potential treat- ies may make pessary use im - polated generally from vaginitis ment products, including vaginal practical, suggesting the need to treatment guidelines.

ERIES ON acidifiers, moisturizers, vaginal re-examine benefits and risks of Use of antimicrobials. Com -

S estrogens, and/or oral or vaginal alternate treatments, such as sur- parisons of the typical vaginal antimicrobials, are described in gery. microscopy findings in symptom- more depth elsewhere in this atic and asymptomatic pessary article, although their compara- Abnormal Discharge users have not been described,

PECIAL tive effectiveness has not been Typical complaints related to and implications in clinical prac-

S studied. Once repeat vaginal vaginal discharge during pessary tice are not known. One study inspection confirms epithelial use include changes in discharge reported higher rates of gram health, a follow-up routine is re- amount, color, or odor. Some stain findings consistent with initiated, typically including pes- temporary increase in vaginal (BV) in pes- sary re-fitting, with or without discharge is commonly reported sary users than in controls (32% modifications in size or shape by new pessary users, which may versus 10%, relative risk of and/or ongoing use of treatments, be reassuring for some women to developing BV 4.37, 95% confi- such as vaginal estrogen. hear. When bothersome symp- dence interval, 2.15 to 9.32) Although temporary pessary toms continue, treatment plan- (Alnaif & Drutz, 2000). Although removal can be expected to ning is generally based on extrap- it is not clear whether the pessary quickly relieve mechanical pres- olation of data from other con- users were symptomatic, the sure and facilitate healing, some texts and on expert opinion. authors hypothesized that pes- women experience serious, acute Initial assessment of changes sary removal 10 days pre-opera- symptoms during pessary re - in discharge should include very tively might normalize vaginal moval. These can include acute careful inspection of the vaginal flora and decrease risk of vaginal prolapse recurrence, pain, uri- epithelium in its entirety, looking cuff . There is no direct nary retention, UTI, and bowel for mechanical injury. Vaginal pH evidence that treatment of pes- dysfunction. For these women, a and microscopy can be assessed, sary users with findings consis- trial of other options may be ben- although little is known about the tent with BV is beneficial related eficial. For example, use of a dif- implications of typical changes to decreasing vaginal discharge ferent shape or size of pessary seen in post-menopausal pessary symptoms, prevention of upper may alter the area of mechanical users (Alnaif & Drutz, 2000). tract infection, or protection of pressure enough to allow heal- Vaginal culture is typically not vaginal epithelium from future ing. Another unstudied option helpful unless otherwise uniden- injury. might be temporary use of an tified yeast organisms are sus- If overgrowth of abnormal inflatable Donut pessary that is pected. If is microbes, such as bacteria or removed nightly. If an alternate present, an endometrial biopsy yeast, is suspected from clinical pessary does not seem safe or should be considered even when signs, symptomatic relief is the practical, other options must be vaginal erosion is identified to treatment goal. If yeast is identi- formulated. For example, acute rule out co-existing problems, fied, any available over-the-count- urinary retention due to recur- such as er or oral anti-fungals may be help- rence of anterior compartment or cancer. ful. It is not known whether pes-

134 UROLOGIC NURSING / May-June 2012 / Volume 32 Number 3 SERIES sary removal during treatment For pessaries in particular, develop and activity levels would improve outcomes. If bacte- the comparative costs and opti- decrease. rial infection is suspected, oral mal intervals for self- and clini- Prevention and treatment of treatment options recommended cian-provided care options, espe- vaginal atrophy relates both to in the United States include cially as they relate to different symptom improvement and metronidazole, , or pessary types (for example, pes- potential pessary complications. tinidazole (Centers for Disease saries that are retained by an Emerging treatments, including Control and Prevention [CDC], intact introitus versus those that selective estrogen receptor mod- 2010). Recommended topical are self-retaining) are also need- ulators (Bachmann, Komi, & the vaginal antimicrobials include ed. Further studies of pelvic Ospemifene Study Group, 2010), creams containing clindamycin function in the presence of pes- and the estrogen precursor S

(CleocinTM) or metronidazole sary-support may be aided dehydroepiandrosterone (DHEA) PECIAL (MetrogelTM) (CDC, 2010). Out - through the use of real-time (Labrie, 2010) are demonstrating come studies in pessary users ultrasound (Fox, 2009). Inno - efficacy in treatment of genital have not been reported. Asso - vations in pessary design contin- atrophy. Alternatives such as ciated options, such as pessary ue to be described (Jones & these may become important as S sterilization, replacement, or tem- Harmanli, 2010). Advances in non-estrogenic treatment options ON ERIES porary removal during treatment, material and biomedical sciences to improve outcomes for pessary can be considered but have not may offer opportunities for clini- users. been studied. cal partnerships to develop addi- tional alternatives for pessary Conclusion

shape and content, devices to aid P Areas for Future Research

pessary self-care, and agents to As the population ages and ESSARIES As this article has illustrated, protect and rapidly heal dam- rates of increase, increas- many recommendations for pes- aged epithelium. ing numbers of women will need sary follow up and complication The role of pessaries in pre- care for dysfunc- management are based on expert venting prolapse progression is tions, including urinary and fecal opinion or extrapolation from not well understood. Initial incontinence and pelvic organ research done in other areas of research suggests that pessary prolapse (Nygaard et al., 2008). women’s health. This emphasizes use may improve prolapse, at Because vaginal support pes- the need and opportunity for least temporarily, in some saries offer a satisfying, low-risk ongoing research. For example, women (Handa & Jones, 2002). option for symptom management there is a need for further research However, it is not clear whether for many women, a pessary trial related to prolapse treatment in pessaries significantly change should be offered even to women general. The overall comparative stress or strain on pelvic support who present with a pre-existing safety and cost-effectiveness of all tissue, or whether some degree of desire for surgery (Clemons, prolapse treatment options, pelvic tissue support can regen- Aguilar, Tillinghast, Jackson, & including observation, pessary, erate under supported condi- Myers, 2004). To optimize safe physical therapy, or surgery at tions. In addition, while women pessary use, providers must be each life stage, remains unclear. may question whether earlier ini- knowledgeable of pessary-related Pelvic floor muscle training tiation of pessary use might slow risks and benefits, vigilant in pes- can also decrease symptoms, or prevent symptomatic prolapse sary follow up, and prepared to such as (Bø, progression, there is little evi- appropriately refer women with 2004), and prolapse-related feel- dence to inform this area of deci- pessary-related problems that ings of bulging and vaginal heav- sion-making. exceed their scope of practice. In iness (Braekken, Majida, Engh, & The needs of an aging popu- a safe and supported environ- Bø, 2010); however, the potential lation require additional research ment, women’s satisfaction with enhanced effect of pessary use in in several areas related to pessary pessary use can also be enhanced combination with regimens of use. For example, there may be by clarifying goals of treatment, pelvic muscle strengthening has increasing opportunity to under- optimizing individual regimens not been well studied. Pessaries stand normal aging of the geni- for use and follow up, and evalu- may be able to play a larger role talia in very old women (over age ating outcomes based on those in surgical outcome prediction 85) and to collect data for very goals. for symptoms such as low back- long-term pessary use (20 years While the evidence base to ache that may not be improved or more), where advancing atro- support successful pessary use by prolapse treatment (Heit, phy may result either in increas- has expanded in recent years, Culligan, Rosenquist, & Shott, ing prolapse as support weakens, much remains to be studied. This 2002), and further inquiry in this or decreasing pessary need as includes the comparative safety of area is suggested. vaginal strictures and adhesions follow-up recommendations and

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the cost-effectiveness of support Braekken, I.H., Majida, M., Engh, M.E., & Fox, W. (2009). Does real-time ultrasound pessaries versus other prolapse Bø, K. (2010). Can pelvic floor muscle play a role in assessing functional training reverse improvement with pessary in place? treatment strategies (Adams, and reduce prolapse symptoms? An Physical Therapy for Pelvic Floor Thomson, Maher, & Hagen, 2004). assessor-blinded, randomized con- Dysfunction. Medicine and Health/ Currently, pessary providers are trolled trial. American Journal of Rhode Island, 92, 1. encouraged to combine their best & Gynecology, 203(2), Freedman, M.A. (2008). Vaginal pH, estro- clinical knowledge and judgment 170.e1-7. doi:10.1016/j.ajog.2010.02. gen, and genital atrophy. Menopause 037 Management, 17(4), 9-13. with informed patient preference Caswell, M., & Kane, M. (2002). Com - Gorti, M., Hudelist, G., & Simons, A. and expert recommendation to parison of the moisturization efficacy (2009). Evaluation of vaginal pessary maximize treatment satisfaction of two vaginal moisturizers: Pectin management: A UK-based survey. with these simple, effective pelvic versus polycarbophil technologies. Journal of Obstetrics & , Journal of Cosmetic Science, 53(2), 81- 29(2),129-131. doi:10.1080/01443610 support devices. 87. 902719813 Centers for Disease Control and Prevention Handa, V.L., & Jones, M. (2002). Do pes- References (CDC). (2010). Sexually transmitted saries prevent the progression of Adams, E., Thomson, A., Maher, C., & diseases treatment guidelines 2010. pelvic organ prolapse? International Hagen, S. (2004). Mechanical devices Retrieved from http://www.cdc.gov/ Urogynecology Journal, 13, 349-352. ESSARIES for pelvic organ prolapse in women. std/treatment/2010/STD-Treatment- doi:10.1007/s001920200078 P Cochrane Database System Review, 2010-RR5912.pdf Heit, M., Culligan, P., Rosenquist C., & 2, CD004010. doi:10.1002/14651858. Clemons, J.L., Aguilar, V.C., Sokol, E.R., Shott, S. (2002). Is pelvic organ pro- CD004010.pub2 Jackson, N.D., & Myers, D.L. (2004). lapse a cause of pelvic or low back Al-Baghdadi, O., & Ewies, A.A. (2009). Patient characteristics that are associ- pain? Obstetrics & Gynecology, 99(1), Topical estrogen therapy in the man- ated with continued pessary use ver- 23-28. doi:10.1016/S0029-7844(01) agement of postmenopausal vaginal sus surgery after 1 year. American 01626-X

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136 UROLOGIC NURSING / May-June 2012 / Volume 32 Number 3 Pessary Care C. (1992). Cervical and vaginal cancers (Replens) on bacterial vaginosis: A associated with pessary use. Cancer, pilot study. European Journal of continued from page 136 69(10), 2505-2509. doi:10.1002/1097- Obstetrics, Gynecology, & Reproduc- 0142(19920515)69:10<2505::AID- tive Biology, 130(1), 132-136. doi:10. National Pressure Ulcer Advisory Panel. CNCR2820691020>3.0.CO;2-O 1016/j.ejogrb.2006.01.007 (2010). Mucosal pressure ulcers: A Shippey, S.H., & Malan, T.K. (2004). Wu, V., Farrell, S.A., Baskett, T.F., & NPUAP position statement. Re - Desquamating vaginal mucosa from Flowerdew, G. (1997). A simplified trieved from http://www.npuap.org/ chlorhexidine gluconate. Obstetrics protocol for pessary management. Mucosal_Pressure_Ulcer_Position_ & Gynecology, 103(5, Pt. 2), 1048- Obstetrics & Gynecology, 90(6), 990- Statement_final.pdf 1050. doi:10.1097/01.AOG.0000121 994. Nygaard, I., Barber, M.D., Burgio, K.L., 834.67077.03 Kenton, K., Meikle, S., Schaffer, J., … Storey, S., Ashton, M., Price, S., Irving, L., the Pelvic Floor Disorders Network. & Hemmens, E. (2009). Women’s (2008). Prevalence of symptomatic experiences with vaginal pessary use. pelvic floor disorders in U.S. women. Advanced Nursing, 65(11), 2350- Journal of the American Medical 2357. doi:10.1111/j.13652648.2009. Association, 300(2), 1311-1316. 05095.x doi:10.1001/jama.300.11.1311 Tulikangas, P.K., Walters, M.D., Brainard, Panpac Medical Corporation. (2010). J.A., & Weber AM. (2001). : Bioteque Inflatable Donut Pessary. Is there a histologic defect? Obstetrics Retrieved from http://www.bioteque. & Gynecology, 98(4), 634-637. com/downloads/files/bioteque_users doi:10.1016/S0029-7844(01)01524-1 _manual-inflatable_donut_pessary- Van Wicklin, S.A. (2006). Preoperative version2.0-finished_version.pdf vaginal preps with chlorhexidine glu- Pott-Grinstein, E., & Newcomer, J.R. conate solution – Letter to the editor. (2001). Gynecologists’ patterns of pre- American Journal of Obstetrics & scribing pessaries. Journal of Gynecology,195(2), 624. doi:10.1016/ Reproductive Medicine, 46(3), 205- j.ajog.2005.11.002 208. Vorherr, H., Vorherr, U.F., Mehta, P., Ulrich, Rubin, R., Jones, K.A., & Harmanli, O.H. J.A., & Messer, R.H. (1984). Anti- (2010). Vaginal evisceration during microbial effects of chlorhexidine and pessary fitting and treatment with povidone-iodine on vaginal bacteria. immediate colpocleisis. Obstetrics & Journal of Infection, 8, 195-199. Gynecology, 116(Suppl. 2), 496-498. doi:10.1016/S0163-4453(84)93811-8 doi:10.1097/AOG.0b013e3181da371d Webster, J., & Osborne, S. (2007). Sarma, S., Ying, T., & Moore, K.H. (2009). Preoperative bathing or showering Long-term pessary use: with skin antiseptics to prevent surgi- Discontinuation rates and adverse cal site infection. Cochrane Database events. British Journal of Obstetrics of Systematic Reviews, 18(2). and Gynecology, 116(13), 1715-1721. CD004985. doi:10.1002/14651858. doi:10.1111/j.14710528.2009.02380.x CD004985.pub3 Schraub, S., Sun, X.S., Maingo, P., Horiot, Wu, J.P., Fielding, S.L., & Fiscella, K. (2007). J.C., Daly, N., Keiling, R., … Vrousos, The effect of polycarbophil gel

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