Sexual and organ function in patients with symptomatic prolapse: are pessaries helpful?

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1 Sexual and organ function in patients with symptomatic prolapse: are pessaries helpful? Annette Kuhn, M.D., a Doris Bapst, a Werner Stadlmayr, M.D., a Kathleen Vits, b and Michael D. Mueller, M.D. a a Division of Urogynecology, Department of Gynecology, Inselspital and University of Bern, Bern, Switzerland; and b Princess Anne Hospital, Southampton, United Kingdom Objective: To evaluate quality of life and pelvic organ and sexual function and pessary use in patients with symptomatic pelvic organ prolapse and to determine reasons which lead to cessation of pessary use. Design: Prospective observational study. Setting: Tertiary referral center. Patient(s): Patients with symptomatic stage II or more prolapse of the anterior, posterior, or apical vaginal wall with or without uterus were included in this study. Intervention(s): We used the Female Sexual Function Index questionnaire and the Sheffield prolapse questionnaire. For quality of life we used the King s Health Questionnaire. Main Outcome Measure(s): Main outcome measures were quality of life and sexual and pelvic organ function. Result(s): A total of 73 women participated in this study; 31 were sexually active. Desire, lubrication, and sexual satisfaction showed statistically significant improvement, and orgasm remained unchanged. Statistically significant improvement in the feeling of bulge occurred, stool outlet problems were significantly improved, overactive bladder symptoms were significantly better, and pessaries did not significantly alter incontinence. Conclusion(s): Pessaries have been shown to be a viable noninvasive treatment for pelvic organ prolapse improving organ and sexual function as well as general wellbeing. (Fertil Steril Ò 2009;91: Ó2009 by American Society for Reproductive Medicine.) Key Words: Pessaries, FSFI, Sheffield prolapse questionnaire, sexual and pelvic organ function, quality of life, pelvic organ prolapse Pelvic organ prolapse affects approximately 50% of parous women over 50 years of age and has a lifetime risk of 30% 50% (1). Patients with clinically significant pelvic organ prolapse usually complain of a sensation of vaginal bulging which may be accompanied by symptoms of bladder, bowel, or sexual dysfunction. Some women do not seek medical advice, because of embarrassment or even fear that the prolapse might be urogenital cancer (2). Received January 17, 2008; revised and accepted February 21, 2008; published online April 12, A.K. has nothing to disclose. D.B. has nothing to disclose. W.S. has nothing to disclose. K.V. has nothing to disclose. M.M. has nothing to disclose. Presented in part at the Swiss Gynaecological Meeting (SGGG), Lugano, Switzerland, June 28 30, Reprint requests: Annette Kuhn, Frauenklinik, Effingerstr.102, CH-3010 Bern, Switzerland (FAX þ ; annette.kuhn@insel. ch). Conservative treatment options for pelvic organ prolapse include pelvic floor exercises (3) and vaginal pessaries usually in combination with local estrogens (4) and can be recommended surgery, particularly given the high rates of reoperation for prolapse of 20% 40% for the anterior compartment, 5% 20% for the posterior compartment, and up to 30% for the apical compartment (5). Pessaries can be used either temporarily while awaiting surgery or as a permanent for the medically unfit, those who have not completed their family, or women who decline surgery for other reasons (6). In Switzerland, pessaries are usually self-administered after a trained nurse has taught the women how to insert and remove the pessary. In this regime, the patient usually inserts the pessary herself in the morning and removes it in the evening or whenever sexual intercourse is intended. Pessaries may prevent prolapse progression after 1 year (7) and have few side effects when handled correctly (8). There is a paucity of data on the effects of pessaries on sexual function and pelvic organ-specific symptoms the treatment with pessaries. The aim of the present study was to evaluate bladder, bowel, and sexual function and pessary use in patients with symptomatic pelvic organ prolapse and to determine reasons which lead to cessation of pessary use. MATERIALS AND METHODS Between December 2005 and January 2006, all female patients with symptomatic stage II prolapse of the anterior, posterior, or apical vaginal wall with or without uterus who were treated in the urogynecologic outpatient department of the Frauenklinik, Inselspital, Bern, Switzerland, were approached to participate in the study. Consent of the local ethics committee was obtained (KEK Bern, 2005, Switzerland). Patients gave written and oral 1914 Fertility and Sterility â Vol. 91, No. 5, May /09/$36.00 Copyright ª2009 American Society for Reproductive Medicine, Published by Elsevier Inc. doi: /j.fertnstert

2 informed consent to participate in the study, as required by the ethics committee. Patients who were unable to communicate in the German language were excluded from the study. Also, patients with a current genital ulcer, a history of bothersome urinary incontinence, or any unexplained genital bleeding were excluded from the study. For sexual function, we used the Female Sexual Function Index (FSFI) questionnaire. The FSFI is a questionnaire consisting of 19 questions which refer to the domains desire, arousal, lubrication, orgasm, and satisfaction. For each question, there is a score range from 0 to 5 or 1 to 5 respectively as described in the FSFI scoring appendix (9). For organ-specific symptoms and quality of life, we used the Sheffield prolapse questionnaire, which includes 25 questions about pelvic organ specific symptoms and their severity, and for quality of life we used the King s Health Questionnaire. The King s Health Questionnaire consists of the domains general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, and severity measures with scores between 0 and 5 or 1 and 5; a change of at least 5 points is considered to be significant (10). All questionnaires are validated, and the latter is validated in German. For the FSFI and Sheffield questionnaires, we used translated versions which were not validated at the time of the study. We defined patients as sexually active who were having sexual activities of any kind, whether heterosexual, homosexual, or autoerotic. We did not enquire specifically about activity details. The general patients charts were used to note difficulties with pessary fitting and the reasons to cease pessary use. Patients were followed-up by telephone survey at 6 and 12 months to ascertain if they were still using the pessary. Questionnaires were filled in by the patients and 3 months after having started the use of pessaries including a local hormonal with estradiol valerate. We used cube pessaries (Sedia) size 1 5 depending on the patients anatomic findings. All patients received 1 hour of instruction with one of the specialist nurses including how to insert and remove the pessary. Patients were advised to insert the pessary in the morning and to remove the pessary in the evening or as required for sexual intercourse. Prolapse staging was performed using the International Continence Society Pelvic Organ Prolapse (ICS-POP) score. The ICS-POP score examination takes nine measures of the position of midline vaginal structures. All of the measurements are in centimeters relative to the hymeneal ring, which is used as the reference point because it is a fixed and easily identified landmark. Any vaginal structure that descends such that the leading edge is at or between 1 cm above and 1 cm past the hymeneal ring is stage II, and any structure or leading edge that descends beyond 1 cm is stage III. This system has excellent inter- and intraexaminer reliability, has gained international recognition as the gold standard of classifying pelvic organ prolapse, and is the first and only system which is recognized by most of the major societies that study pelvic organ prolapse: The ICS, the American Urogynecologic Society, and the Society of Gynecologic Surgeons (11). Statistics were performed using GraphPad Statmate 2.0; for power analysis, InStat for Windows version 4.0 and Prism version 5.0 for Windows were used. For power analysis, we calculated that 30 pairs would be necessary for a significance level of a¼.05 (two-tailed) and a power of 80% for a difference of D¼2.6 points per domain. RESULTS Of 102 patients, 73 were willing to participate in the study. Reasons to decline were not wanting to insert a foreign body into the vagina (n ¼ 14), refusal of conservative in general (n ¼ 12), and inability to fill in the questionnaires (n ¼ 3). Evaluation at 3 months for the questionnaires and at 6 and 12 months for telephone survey (pessary use only), produced 71 complete data sets; 2 patients were lost to follow-up. Median age was 70.3 years (range 45 89, 95% confidence interval [CI] ), BMI was 28.9 kg/m 2 (range , 95% CI ), and parity was 2 (range 0 4, 95% CI 1 3). Sixty-three patients were postmenopausal with systemic hormone replacement in 12 and local estrogen in three cases; five patients were perimenopausal, and five were premenopausal. Two patients were on antidepressants, seven patients were on warfarin owing to a history of pulmonary embolism or deep vein thrombosis, 18 patients used antihypertensive drugs, and nine patients were on regular pain medication for various reasons. Five patients had had prolapse surgery in the past (uterine descent, n ¼ 4; cystocele, n ¼ 1), and eight patients had had general gynaecologic surgery (n ¼ 5 hysterectomy for benign bleeding disorders; n ¼ 1 for cervical cancer; and n ¼ 2 for unknown reasons). Prolapse staging according to the ICS-POP score pessary use is shown in Table 1, which summarizes all descended compartments; because most of the patients suffered from more than one descended compartment, the combinations of descending compartments are summarized in Table 1. Sexual Function as Determined by FSFI is Shown in Table 2 Eight patients had de novo urinary incontinence with pessary use; 31 patients were sexually active. As determined by the Sheffield Prolapse questionnaire, improvement of bulging feeling was statistically significant (P<.001), stool outlet problems were significantly improved (P¼.0002), overactive bladder symptoms (OAB) were significantly better (P¼.0289), and incontinence Fertility and Sterility â 1915

3 TABLE 1 Clinical examination pessary. ICS-POP score (no. of patients). descent stage II descent stage III Cystocele stage II Cystocele stage III Rectocele stage II Rectocele stage III 12 * descent stage II * descent stage III Cystocele stage II * 3 0 Cystocele stage III 3 5 * Rectocele stage II * Rectocele stage III * 5 * Not applicable. was not significantly altered (P¼.832; all Student t test) by cube pessaries. Over time, pessary use was discontinued as determined by telephone survey: At 6 months, 33 patients continued to use their pessaries, and after 12 months pessary use remained stable with 32 patients still using the pessaries (Fig. 1). Surprisingly, most of the ongoing pessary users were sexually active (n ¼ 28). Reasons to cease pessary use were: loss of pessary daily activities or bowel emptying (n ¼ 10), the desire to solve the health issue by an operation (n ¼ 9), bothersome de novo stress urinary incontinence (n ¼ 7), inability to insert and/or remove the pessary (n ¼ 6), pain or feeling of discomfort (n ¼ 4), and unspecified reasons (n ¼ 5). DISCUSSION A survey of physicians, nurses, and patients found that subjective measures and improvement in quality of life were regarded by all groups as the most important outcomes in urogynecologic studies (12). In the present study, we used validated tools to estimate the effects of pessaries on sexuality, pelvic organ functions, and quality of life and found a significant improvement in almost all aspects of sexual function, pelvic organ specific prolapse symptoms, and quality of life. The FSFI and Sheffield prolapse questionnaires were not validated in German, because at the time of the study a validation in German was not available. Pelvic organ prolapse has a negative impact on sexual function (9). Although the number of sexually active patients was small in this study (n ¼ 31) desire, lubrification, and sexual satisfaction improved significantly. Desire and satisfaction may also be influenced by the improvement of general well-being, which may alter the patients self esteem. Lubrication is known to be positively influenced by local estrogen treatment (13); therefore, local estradiol valerate may also be responsible for the improvement in sexual function. The findings of the present study provide reassurance to patients that a vaginal pessary does not interfere negatively with sexual activity and may even improve sexual function. Most of those who continued using pessaries were patients who were sexually active; we cannot be sure if this is because pessary users were more compliant because of their improved sexual life or that sexually more active patients were possibly less reluctant to touch their genitals. The self-administered insertion and removal of pessaries supports sexuality, particularly with cube pessaries where intercourse is mechanically possible only after removal because the cube usually takes the whole vaginal space. We do not know if these results are applicable TABLE 2 Sexual function (Female Sexual Function Index) and pessary treatment (3 months data). Desire Desire Orgasm Orgasm Lubrication Lubrication Satisfaction Satisfaction Median Range % CI P value <.01 >.05 <.001 < Kuhn et al. Pessaries and sexual and pelvic organ function Vol. 91, No. 5, May 2009

4 FIGURE 1 Results of the King s Health Questionnaire. Left bars: pessary ; right bars: after (3 months data). 80 General Health, p< Role Limitations; p<0.01 Score 40 Physical Limitations; p< Social Limitations, p< Personal Relationships, p<0.01 Emotions, p=0.09 Incontinence impact; p<0.01 Sleep/Energy, p=1 Symptom Severity, p<0.01 to ring pessaries or Gelhorn pessaries but may assume that as long as the prolapse is well supported other pessaries may have a similar effect. The present study was nonrandomized and included no comparative nontreatment arm; a placebo control would obviously not be practical. Because patients undertaking any intervention could be hopeful of an improvement in functioning, this may result in a placebo effect which we have to take into consideration when discussing our results. Although several observational studies (14, 15) have evaluated prolapse-specific organ symptoms with pessary use, only two (2, 16) have reported a reduction in general pelvic organ prolapse symptoms, such as bulge, voiding dysfunction, and OAB symptoms. Clemons et al. (14) reported an incidence of urinary incontinence of 36% urge incontinence and 27% stress incontinence insertion of a pessary, Fernando (2) found 72% of urge incontinence and 66% of stress incontinence showed no significant improvement in incontinence after pessary use. We excluded patients with bothersome incontinence, because we used cube pessaries only, which are not designed to treat incontinence (17). They do not provide specific support to the bladder neck or suburethral area which suburethral pessaries do. The incontinence scores of the prolapse questionnaires were not altered and treatment. The OAB symptoms improved significantly with the use of pessaries in our study, which is also a possibility after reconstructive surgery for pelvic organ prolapse in up to 50% of cases (18, 19). As stated, the use of local estrogens may have influenced the improvement of OAB (20). The underlying pathology of OAB in patients with significant prolapse may be obstructive, owing to a distorted urethra which is resolved after restoring normal anatomy. In the present study, we did not perform urodynamics, because patients underwent conservative only and urodynamics would not have influenced the management of patients; therefore, we cannot comment on whether or not obstruction was a factor. After 12 months, 44% (n ¼ 32) were still using their pessary and were content with their situation. Maito et al. (21) analyzed predictors of successful pessary fitting in 120 women and found continuation rates of 89% for prolapse treatment and 81% for stress incontinence respectively. That retrospective study defined continuation as a successfully fitted patient who returned at least once after the initial fitting with the pessary still in use and identified severe posterior prolapse as an independent predictor of pessary discontinuation. In the present study, the main group of patients who discontinued pessary use were women where pessaries fell out (13.7%), those with de novo stress incontinence (12.3%), and patients who were unable to handle pessary insertion or Fertility and Sterility â 1917

5 removal themselves successfully (9.6%). Further adverse events, such as ulcerations or vaginal discharge, were not observed (22), which is probably owing to daily pessary removal and estrogen use. Problems retaining pessaries may be caused by a large hiatus and levator muscles which are wide apart and do not support the pessary sufficiently. Cube pessaries are not recommended to be left inside for days or weeks because the vacuum caused by the pessaries can significantly alter tissue qualities (23), so patients who are unfit to handle the pessaries themselves because of other medical reasons, such as immobility or obesity, should not be recommended to use cube pessaries. In these cases, different pessaries, such as Gelhorn or shelf pessaries, which are inserted and removed by medical staff can be suggested if conservative is desired. In conclusion, cube pessaries have been shown to be a viable noninvasive treatment for pelvic organ prolapse improving pelvic organ and sexual function as well as general well-being. Conservative is a valuable option, but the inability to retain pessaries, de novo stress incontinence, and inability of handling limit the use of pessaries. Acknowledgments: The authors thank Ursula Bosshard and Annette Frey, both specialist incontinence nurses, for their support, which enabled us to perform this study. REFERENCES 1. Subak LL, Waetjen LE, van den Eeden S, Thom DH, Vittinghoff E, Brown JS. Costs of pelvic organ prolapse surgery in the United States. Obstet Gynecol 2001;98: Fernando RJ, Thakar R, Sultan AH, Shah SM. Effect of vaginal pessaries on symptoms associated with pelvic organ prolapse. Obstet Gynecol 2006;108: Nygaard I. Prevention of exercise incontinence with mechanical devices. J Reprod Med 1995;40: Pott-Grinstein W, Newcomer JR. Gynecologists pattern of prescribing pessaries. 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