Pelvic organ prolapse affects approximately 50% of parous women over 50 years of age, with a lifetime prevalence risk of 30–50%.1 Women with clinically significant pelvic organ prolapse usually complain of a sensation of a vaginal bulge that may be accompanied by symptoms of urinary, bowel, or sexual dysfunction. However, many of these women do not seek medical advice for a bulge in the vagina because of embarrassment or fear that it might be a cancer.2
Nonsurgical treatment modalities for pelvic organ prolapse include pelvic floor exercises (Jarvis SK, Hallam TK, Dietz HP. Pre- and postoperative physiotherapy intervention for gynaecology surgery: a single blind randomised controlled trial. Presented at the XIV Annual Scientific Meeting of the Australian Gynaecological Endoscopy Society, Brisbane, Australia, May 26–29, 2004)3,4 and vaginal pessaries.4,5 Pessaries are used either as a temporary measure to control symptoms while awaiting surgery or as a permanent alternative to surgery for those who are medically unfit, those who decline surgery, or those who may yet want to bear children.6 Pessaries have the added advantage that they can be changed in the primary care setting. Furthermore, it has been shown that pessaries may reverse the degree of prolapse after 1 year.7 Despite potential benefits, there is some reluctance to use pessaries as first-line management because they are perceived as inconvenient by both the patient and physician.8 Although there are prospective studies evaluating the effect of pessaries on pelvic organ function, none used validated questionnaires.9 Use of validated questionnaires is important because they are reproducible and reliable in assessing symptoms (Bradshaw HD, Hiller L, Radley S, Farkas AG, Radley SC. Development and psychometric testing of a symptom index for pelvic organ prolapse. J Obstet Gynaecol, in press). The aims of this study were to prospectively evaluate general, bladder, bowel, and sexual symptoms before pessary use and 4 months after use and to identify factors associated with failed pessary retention.
MATERIALS AND METHODS
All women referred to a specialist urogynecology unit in the United Kingdom between June 2002 and January 2005 with symptomatic pelvic organ prolapse who agreed to pessary treatment were included in this study. Women who elected surgical treatment at the first visit and those who were unable to respond to the questionnaire (non–English-speaking patients, those with learning difficulties, and patients with dementia) were excluded from the study. At the first visit demographic data were collected, and the validated Sheffield pelvic organ prolapse symptom questionnaire (Bradshaw et al, in press) was used to assess general, bladder, and bowel symptoms, as well as sexual function related to pelvic organ prolapse before pessary insertion (baseline). The Sheffield pelvic organ prolapse questionnaire addresses the impact of prolapse on bladder, bowel, and sexual function on a four-point ordinal response scale (Never, Occasionally, Most of the time, All of the time). The content validity, criterion validity, reliability, and responsiveness of the questionnaire have been proven to be a reliable and valid instrument for the assessment of symptoms related to uterovaginal prolapse. It has also been proven to be sensitive to change of symptoms. This questionnaire is now used in electronic pelvic floor symptom assessment.10
The questionnaire was completed by women before being seen by the urogynecologist in the outpatient clinic. All patients were examined, and the degree of pelvic organ prolapse was graded according to the Baden-Walker halfway vaginal profile.11 We assessed the grade of prolapse using the Baden-Walker halfway vaginal profile due to familiarity and its simplicity of use in the clinical setting. The pelvic organ prolapse quantification (POP-Q) system12 is difficult to learn and time-consuming in a clinical setting13 but has just as good interexaminer reliability as the Baden-Walker system.14 The ring pessary was the pessary of choice, and in some patients different sizes of pessaries were tried before comfortable retention was obtained. If the ring pessary was unsuccessful and the patient was sexually active, a cube pessary was used. We advised women to remove the cube pessary before sexual intercourse and to replace it afterward. If the ring pessary was unsuccessful and the patient was not sexually active, a Gellhorn or a doughnut pessary was inserted. The patient was allowed to leave if there was absence of expulsion on movement, squatting, and carrying out the Valsalva maneuver, but pessary placement was reviewed after 2 weeks. If the patient was comfortable and satisfied with the pessary, she was followed up in the dedicated pelvic organ prolapse clinic 4 months later. Pessary success was defined as one where there was reduction of prolapse without discomfort at the 2-week follow-up. Persistent inability to retain a pessary or the need for removal due to pain, discomfort, or bleeding at 2 weeks was considered as pessary failure. All women completed the Sheffield pelvic organ prolapse questionnaire again at the 4-month follow-up visit in the outpatient clinic before examination and change of pessary. The 4-month responses were compared with the baseline responses.
This questionnaire forms part of our normal evaluation of patients with pelvic organ prolapse. All patients gave written consent to use the data from questionnaires for scientific publications, and this was sanctioned by the Croydon Local Research and Development Committee.
Univariate and multivariate logistic regression analysis was carried out to identify the risk factors for failure to retain pessary using NCSS 2001 (Number Cruncher Statistical Systems, Hintze, Kaysville, UT) software. The Wilcoxon signed rank test was used to analyze the change of symptoms from baseline to 4 months after pessary insertion. The χ2 test was used to compare the proportions between the responders and nonresponders at 4 months, and the t test was used to compare the means. Statistical analysis was carried out with SPSS 11.5 (SPSS Inc, Chicago, IL).
Of the 203 patients with symptomatic pelvic organ prolapse (mean age 69 years, standard deviation 1.5; median parity 2, range 0–8) who fulfilled the inclusion criteria, 153 (75%) successfully retained the pessary at 2 weeks, and 97 (48%) completed the 4-month follow-up (Fig. 1). Table 1 shows the change of general, bladder, bowel, and sexual symptoms of the remaining 97 patients at baseline and 4 months after successful pessary insertion. There was no significant difference in the change of symptoms between different types of pessaries.
Reasons for failure to retain the pessary are shown in Figure 1. In the success group, three (3%) women complained of initial mild vaginal bleeding, and two (2%) complained of mild pain and discomfort. However, these symptoms resolved, and all continued with the pessary. Twenty (40%) patients in the failure groups were sexually active.
Of the 50 patients who failed to retain the pessary at 2 weeks, 13 (26%) subsequently had either vaginal hysterectomy, anterior colporrhaphy, and/or posterior colpoperineorrhaphy alone; 10 (20%) had either vaginal hysterectomy, anterior colporrhaphy, and/or posterior colpoperineorrhaphy combined with incontinence surgery; 4 (8%) had sacrocolpopexy; and 10 (20%) were awaiting surgery for pelvic organ prolapse. Another 13 (26%) patients declined any form of treatment for pelvic organ prolapse.
Both success and failure groups were comparable in age and ethnicity. Univariate logistic regression analysis showed that previous hysterectomy (odds ratio [OR] 6.67, 95% confidence interval [CI] 2.90–15.40, P = .001), previous pelvic floor repair (OR 4.33, 95% CI 1.67–11.20, P = .003), and increasing parity (OR 1.55, 95% CI 1.20–2.00, P = .001) were significantly associated with failure to retain a pessary (Table 2). However, when multivariate regression analysis was carried out, only previous hysterectomy (OR 4.57, 95% CI 1.71–12.24, P = .002), and increasing parity (OR 1.52, 95% CI 1.14–2.02, P = .004) were significantly associated with failure to retain a pessary (Table 3).
Fifty-eight (60%) women in the success group and 25 (50%) women in the failure group had a cystocele of grade 2 or more. There were 18 (19%) women in the success group and 15 (30%) women in the failure group who had a rectocele of grade 2 or more. Compared with the 25 women (26%) in the success group, 9 (18%) women in the failure group had grade 2 or more uterine descent. These differences regarding the degree and site of prolapse between success and failure groups were not statistically significant.
The women who responded to the 4-month questionnaire (mean age 72.2 years, standard deviation [SD] 12.6) were significantly older than those who did not respond to the questionnaire at 4 months (mean age 65.1, SD 14.4) (P = .002). The responders group had a significantly lower parity (median 2, range 0–6) compared with the nonresponders (median 3, range 0–7) (P = .004).
Although pessaries have been in use for several centuries,15 there are few prospective studies using a validated symptom questionnaire to evaluate the improvement of symptoms after successful pessary insertion. Our study shows a statistically significant improvement in general symptoms and urinary and defecatory symptoms. Although the majority of patients were not sexually active, a significant proportion of sexually active patients reported an increase in frequency of sexual activity and satisfaction. This prospective study confirms the widespread belief among urogynecologists16 that vaginal pessaries are an effective and simple method of alleviating symptoms of pelvic organ prolapse and associated pelvic organ dysfunction. In addition to improvement in bladder and bowel function, vaginal pessaries improve sexual function.
Although several observational studies9,17 have evaluated pelvic organ prolapse symptoms with pessary use, only Clemons et al9 reported a change in pelvic organ prolapse symptoms before and after successful pessary use. They evaluated 73 patients who successfully retained a pessary at 2 months and reported a reduction in general pelvic organ prolapse symptoms such as a bulge (90% to 3%), pressure (49% to 3%), and discharge (12% to 0%) before and 2 months after pessary use. In addition, they reported an improvement in voiding dysfunction (23% to 53%), stress urinary incontinence (27% to 45%), and urge urinary incontinence (26% to 46%). However, in contrast to our study, they did not use a validated questionnaire to assess the range of general, bladder, and bowel symptoms and sexual function. Furthermore, patients were asked direct questions by interview as opposed to being given a questionnaire. In our study we did not assess the quality of life because there were no validated quality-of-life assessment tools for pelvic organ prolapse at the commencement of our study. Such an assessment tool for pelvic organ prolapse did not become available until the one published by Digesu et al.18
Clemons et al9 reported a lower incidence of urinary incontinence (36% urinary urge incontinence and 27% stress urinary incontinence) before insertion of a pessary. However, we found that 72% of women had urge urinary incontinence and 66% had stress urinary incontinence before pessary insertion. This could be explained by the different methods used in the two studies to evaluate symptoms and highlights the importance of using validated tools for evaluation of symptoms. We did not find a significant improvement in stress urinary incontinence in patients who retained a pessary. It is possible that, although pessaries provide support and reduce pelvic organ prolapse, they may not be completely effective in correcting the underlying pathology, such as inadequate suburethral support. Moreover, we used pessaries primarily to correct pelvic organ prolapse, and none of these patients had an incontinence ring inserted. It has been reported that 40–50% of patients with severe pelvic organ prolapse also suffer from detrusor overactivity,19,20 and the likelihood of resolving detrusor overactivity after corrective surgery for pelvic organ prolapse is between 33% and 50%.21 It is therefore possible that the patients in the present study who reported an improvement in overactive bladder symptoms may have had secondary detrusor overactivity due to pelvic organ prolapse that was rectified by the vaginal pessary.19,20 However, we did not perform urodynamic studies in our patients to confirm detrusor overactivity because this would not have changed the management.
Pelvic organ prolapse is known to be associated with anatomical distortion of the urethra22 and may cause voiding difficulties. Gradual increase in the maximum urethral closure pressure with advancing pelvic organ prolapse23 and progressive decline in flow rates with increasing grades of pelvic organ prolapse19 have been previously reported. Therefore, the improvement in voiding symptoms with pessary use may be explained by restoration of the anatomy of bladder and urethra.
Pelvic organ prolapse is reported to have a negative impact on female sexual function.24,25 However, none of the previous studies have evaluated the effect of sexual function after pessary use for pelvic organ prolapse. Although the number of sexually active patients in this study was small (n = 26), it was interesting to note that there was a significant improvement in sexual function (both frequency and satisfaction) 4 months after pessary use (Table 1). Most women seen in our clinic were anxious about having sexual intercourse after insertion of the vaginal pessary. The findings of this study provide reassurance to women that a vaginal pessary may not interfere mechanically with sexual activity and may even improve sexual function.
The reported success rate of pessary use is between 56% and 74% at 2–3 months.7,9,17,26 Of these studies, Clemons et al9 reported the highest success rate of 73% at 2 months, similar to our success rate of 75% at 2 weeks. Sulak et al17 analyzed the reasons for discontinuing pessary use and found that 40% were due to inconvenience or inadequate relief of symptoms, 23% due to difficulty in removing the pessary, 13% due to discomfort, and 6% due to expulsion. By contrast, most of the failures in the present study were due to expulsion of pessary (78%) despite the use of different types of pessaries when the ring pessary failed. We avoided using a Gellhorn pessary if the patient was sexually active. Sulak et al17 used the Gellhorn pessary in 96% of their patients, which might explain the lower incidence of expulsion in their study. We could not use the Gellhorn pessary in 20 (40%) women in whom the ring pessary failed because they were sexually active.
We found that previous hysterectomy and increasing parity were risk factors associated with pessary failure. A possible explanation is that the protruding cervix may serve to stabilize the ring pessary. Furthermore, after hysterectomy there may be narrowing of the vaginal vault, resulting in expulsion of the pessary. Although Clemons et al27 did not identify previous hysterectomy as a risk factor, they found that failure to retain pessary was more likely with a short vaginal length and a wide vaginal introitus on POP-Q measurement. However, a recent retrospective case review of 407 patients by Mutone et al28 reported that failure to retain a pessary at 3 weeks was significantly associated with previous hysterectomy and reconstructive surgery for prolapse. We did not find a correlation between the type of hysterectomy and success or failure in retaining a pessary.
Similar to the studies by Clemons et al27 and Mutone et al,28 we also did not find a significant difference in age or ethnicity between failure and success groups. In addition, no significant difference in the degree and site of pelvic organ prolapse was found between success and failure groups. Mutone et al28 in their retrospective study, in which degree of pelvic organ prolapse was assessed by the POP-Q system, also did not find a correlation between degree of pelvic organ prolapse and failure to retain pessary at 3 weeks.
Although rare with proper use, complications with pessaries have been reported, namely, actinomycosis and bacterial vaginosis,29,30 bleeding, discomfort, pain, vaginal erosion, impaction, excoriation, and ulceration, especially with atrophic vaginitis.26 When neglected, more serious complications, such as peritonitis, fistula formation,22,29 erosion into the bowel or bladder and dense adherence to other pelvic structures,31 hydronephrosis,22,32 and vaginal cancer,32 have been reported. In our study among patients who successfully retained a pessary, only three (3%) patients complained of initial mild vaginal bleeding, and two (2%) complained of mild pain and discomfort, which later resolved. However, our study was restricted to a 4-month follow-up, but regular removal and replacement, including inspection of the vagina every 3–12 months, have been advocated to prevent impaction.6,26 Pessary use for pelvic organ prolapse is safe and avoids the complications of surgery. It is therefore justifiable to offer pessaries in the initial management of pelvic organ prolapse to all patients who opt for conservative management and also those awaiting surgery. This issue is particularly important with the increasing life expectancy of women.32
Given the difficulty in conducting a randomized controlled trial comparing pessary use and surgery, current evidence indicates a good success rate with initial pessary use. Furthermore, surgery is not without a risk of morbidity, and because 30% of women require repeated surgery for pelvic organ prolapse,33 pessaries should have an important place in its management. Indeed, Handa and Jones7 reported improvement in the degree of pelvic organ prolapse 1 year after pessary use. We are currently conducting a 1-year follow-up of these women to confirm whether the benefits of pessary use can be sustained.
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