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Effect of Pessary Use on Genital Hiatus Measurements in Women With Pelvic Organ Prolapse

Jones, Keisha MD1; Yang, Linda MD2; Lowder, Jerry L. MD1; Meyn, Leslie MS3; Ellison, Rennique1; Zyczynski, Halina M. MD1; Moalli, Pamela MD, PhD1; Lee, Ted MD2

doi: 10.1097/AOG.0b013e318181879f
Original Research
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OBJECTIVE: To compare the size of the genital hiatus in women wearing a pessary for pelvic organ prolapse after consistent pessary use, describe characteristics of patients who continue use, and assess change in pelvic floor symptoms.

METHODS: This was an observational cohort study of 90 women seeking nonsurgical management of symptomatic prolapse. Our primary outcome was change in genital hiatus (in centimeters) after 3 months of consistent pessary use. Pelvic floor symptoms were assessed with the Pelvic Floor Distress Inventory. Change in genital hiatus measurements and Pelvic Floor Distress Inventory scores were assessed using a paired Student t test. Between-group differences were evaluated using the Student t, Mann Whitney U, and Fisher exact tests, where appropriate. Logistic regression was used to assess baseline characteristics predictive of continued pessary use.

RESULTS: The average (±standard deviation) age of participants enrolled was 62.8 ±13.2 years. Median parity was 3, and 87.7% were postmenopausal. Forty-two (47%) continued pessary use at 3 months. After 2 weeks, there was a decrease in the size of the genital hiatus measured with strain from 4.8±1.6 cm to 4.1±1.2 cm, P<.001, which persisted at 3 months (3.9±1.1 cm, P<.001). The greatest change occurred with the Gellhorn pessary. Baseline Pelvic Organ Prolapse Quantification system point Aa was positively associated with continued pessary use at 3 months, and perineal body at rest was negatively associated.

CONCLUSION: After 3 months of pessary use, genital hiatus size decreased significantly. Pessary use results in significant anatomic changes to the genital hiatus in patients with pelvic organ prolapse.

LEVEL OF EVIDENCE: III

After 3 months of pessary use, genital hiatus size decreased significantly.

From the 1Division of Female Pelvic Medicine and Reconstructive Surgery, and 2Division of Gynecologic Specialties, Minimally Invasive Surgery, Department of Obstetrics & Gynecology and Reproductive Sciences, and 3Division of Obstetrics & Gynecology and Reproductive Sciences, Magee-Womens Hospital, University of Pittsburgh, Pennsylvania.

Corresponding author: Pamela Moalli, MD PhD, Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics & Gynecology and Reproductive Sciences, 300 Halket Street, Pittsburgh, PA 15213; e-mail: pmoalli@mail.magee.edu.

Financial Disclosure Dr. Zyczynski performed research under contract with Ethicon Women’s Health and Urology (Livingston, UK). The other authors have no potential conflicts of interest to disclose.

Vaginal pessaries are a useful alternative to surgery in the management of symptomatic pelvic organ prolapse. Specifically, pessaries are an excellent treatment option for patients who are poor surgical candidates, have not completed child bearing, or do not desire surgical correction. A survey of pessary use by members of the American Urogynecologic Society indicated that 77% of the respondents used pessaries as first-line therapy for pelvic organ prolapse.1 Despite their routine use, few quantitative data are available regarding efficacy in treating anatomic changes that occur with symptomatic pelvic organ prolapse.2

The genital hiatus is the measurement obtained on the pelvic organ prolapse quantification examination, defined as the distance in centimeters from the external urethral meatus to the posterior fourchette.3 A widened genital hiatus is frequently observed in women with prolapse.4 Many reconstructive pelvic surgeons perform a perineorrhaphy or levator myorrhaphy at the time of prolapse repair in an attempt to reduce the size of the genital hiatus, presumably to minimize the risk of recurrence.5 Previous studies have suggested that the genital hiatus is smaller in women with successful outcomes after surgical repair as compared with women who failed corrective surgery.6

Intuitively, it seems likely that a smaller genital hiatus, whether surgically altered or due to pessary use, would be associated with a better outcome in terms of symptoms, recurrence, and progression of prolapse; however, this has not been shown scientifically. In addition, it is unclear if symptom improvement correlates with a reduction in the size of the genital hiatus. The aim of this study was to better understand the effect of prolapse reduction using a pessary. Specifically, we assessed the effect of pessary use on genital hiatus size. Additionally, we evaluated the changes that occurred in pelvic floor symptoms related to bother after consistent pessary use and the patient characteristics that were associated with continued pessary use.

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MATERIALS AND METHODS

Between September 2002 and November 2006, we conducted a prospective, observational cohort study of pessary use in women with symptomatic pelvic organ prolapse. Women with symptomatic pelvic organ prolapse interested in nonsurgical treatment were enrolled from the Center for Continence and Pelvic Floors Disorders at the University of Pittsburgh Medical Center Magee-Womens Hospital. Women were excluded from the study if they were already using a pessary or had any of the following contraindications to pessary use: active infections of the vagina or pelvis including vaginitis or pelvis inflammatory disease, undiagnosed vaginal bleeding, vaginal erosions, or severe dementia. This protocol was approved by the University of Pittsburgh Institutional Review Board, and all participants provided informed consent before participating.

Baseline demographic data, coexisting medical conditions, medication use, menopausal status, use of hormone replacement, gravidity, parity, and history of prior pelvic surgery were recorded. Each woman underwent a physical examination that included the Pelvic Organ Prolapse Quantification (POP-Q) system as described by the International Continence Society.3 In addition, genital hiatus and perineal body with maximal Valsalva were measured.7 The Pelvic Floor Distress Inventory questionnaire was completed by each participant at baseline and at follow-up visits. The Pelvic Floor Distress Inventory is a validated, self-reported, 43-item pelvic floor dysfunction–specific quality-of-life questionnaire with three scales addressing 1) urinary symptoms (Urinary Distress Inventory); 2) prolapse symptoms (Pelvic Organ Prolapse Distress Inventory); and 3) colorectal symptoms (Colorectal Distress Inventory). The Pelvic Floor Distress Inventory uses a Likert scale to measure the presence and bother of symptoms, with higher scores representing more bother. Pelvic Floor Distress Inventory scores range from 0–1,000.8

After completion of the baseline Pelvic Floor Distress Inventory, physical examination, and baseline data collection, each participant was fitted with a pessary using a standardized protocol. First, an appropriately sized ring pessary was inserted. An incontinence ring was fitted when both prolapse and incontinence was present on examination. If the participant did not comfortably retain the pessary, an alternative pessary type was selected at the discretion of the examining physician. Women who were successfully fitted with a pessary were asked to wear the pessary for a minimum of 3 months, with follow-up visits at 2 weeks and 3 months.

Once participants were fitted with a pessary they were instructed to return in two weeks for pessary removal and cleaning, vaginal inspection, and completion of the Pelvic Floor Distress Inventory. Participants were instructed to leave the pessary in place continuously until the 2-week visit. If participants expressed interest in learning removal, reinsertion, and care of the pessary, they were instructed to do so at the 2-week follow-up visit. Otherwise, the pessary was kept in place until their 3-month follow-up visit. Our standard practice is to recommend removal at least once weekly and for intercourse, if necessary, for patients managing their own pessaries. Genital hiatus and perineal body measurements at rest and with strain, with and without pessary in place, and the Pelvic Floor Distress Inventory was administered at each visit.

If the first pessary was an unsuccessful fit (expulsion, discomfort, or inadequate relief of symptoms) the participant returned for refitting with a new pessary. If the second pessary was successfully retained, the participant returned to the office for evaluation at 2 weeks and 3 months after the second pessary insertion. This algorithm was repeated until a satisfactory fit was achieved or the participant elected different or no treatment. All participants who discontinued pessary use were asked to select the most important and second most important reasons for discontinuing pessary use: 1) inadequate relief of symptoms; 2) caused pain; 3) decided to have surgical treatment; 4) difficulty urinating; 5) difficulty moving bowels; 6) fell out; 7) odor; 8) discharge; and 9) other.

Continuation was defined as participants who were fitted with a pessary and had successfully continued use at the 3-month visit. Discontinuation was defined as any participant who either 1) was lost to follow-up; or 2) discontinued pessary use before 3 months. For the final analysis, participants who maintained continued pessary use at 3 months were compared with those participants who discontinued pessary use. Our primary outcome was change in genital hiatus, calculated as baseline genital hiatus minus 3-month genital hiatus in centimeters. At each visit measurements were obtained with and without the pessary in place. The measurements used in the analyses and reported in this article refer to those taken without the pessary in place.

Previous studies using POP-Q measurements have reported a mean genital hiatus of 3.5 cm in women with uncorrected prolapse.7 We defined a clinically significant change in the genital hiatus before and after pessary use as 1 cm or more. It was estimated that a sample size of 18 would have 90% power to detect at least a 1-cm difference in genital hiatus measured before and after pessary use based on a paired Student t test evaluated at the two-tailed 0.05 significance level and an assumed variance of 1.5. A secondary aim was to determine whether the amount of change in the genital hiatus before and after pessary use differed between women with stage I/II pelvic organ prolapse and stage III/IV pelvic organ prolapse, based on baseline POP-Q measurements. A sample size of 18 in each group (stage I/II and stage III/IV) would have 80% power to detect at least a 1-cm difference in genital hiatus measured before and after pessary use based on a two-sample Student t test. To account for a 20% percent loss to follow-up we planned to enroll 22 patients in each group. However, due to an unexpected high discontinuation and lost to follow-up rate, we expanded our sample size to a total of 90 patients.

Between-group differences were evaluated using Student t tests for normally distributed continuous variables and Mann-Whitney U tests for those variables that a graphical display of the data and the values of the skewness and kurtosis statistics indicated a significant departure from symmetry. Categorical variables were analyzed using Fisher exact tests. For the continuation group, differences for Pelvic Floor Distress Inventory scores, genital hiatus, and perineal body measured before and after pessary use were compared using a paired Student t test. Multivariable stepwise logistic regression was used to assess baseline characteristics predictive of continued pessary use. Pearson’s correlation coefficient was used to evaluate the association between change in genital hiatus and change in Pelvic Floor Distress Inventory scores.

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RESULTS

Between September 2002 and November 2006, 90 women electing nonsurgical management of prolapse were enrolled in the study and fitted with pessaries according to the study protocol. All eligible participants were included in the study. The average age (±standard deviation) of all participants enrolled was 62.8±13.2 years, median parity was 3, and 87.7% were postmenopausal. Forty-two patients (47%) had continued pessary use at 3 months, whereas 48 patients (53%) discontinued their pessary. Sixteen patients (18%) were lost to follow-up and were included in the discontinued pessary use group. Baseline demographic information for all 90 participants enrolled in the study is outlined in Table 1. We found no significant differences in participants who continued pessary use and those who discontinued pessary use with respect to menopausal status, age, prolapse severity, or previous hysterectomy. There was no significant difference in the number of pessaries fitted for each group. There were significant differences in the baseline perineal body at rest, point Aa, and point D between these groups (Table 2).

Table 1

Table 1

Table 2

Table 2

In those continuing pessary use, at final pessary fitting, 23 patients (55%) were fit successfully with a ring pessary with platform, 8 (19%) with a Gellhorn, 3 (7%) with an incontinence ring with knob, and 4 (10%) with an oval pessary. No patient required more than three fittings. In patients who discontinued pessary use, the most important reason given for stopping pessary use was repetitive expulsion of pessary (34%) and inadequate relief of symptoms (28%). Additionally, 44% of the women who discontinued pessary use decided to proceed with surgical correction of their prolapse.

In the continued pessary use group, genital hiatus at rest was significantly smaller at 3 months compared with baseline (2.9±1.0 cm compared with 3.4±1.2 cm, (P=.019). There was not a significant difference at the 2-week assessment in genital hiatus size at rest (3.2±1.2 cm compared with 3.4±1.2 cm, (P=.131). We also assessed genital hiatus with strain, which was significantly smaller at both the 2-week (4.1±1.2 cm) and 3-month visit (3.9±1.1 cm) compared with baseline 4.8±1.6 cm, (P<.001). Perineal body at rest was not significantly larger at 3 months compared with baseline (3.6±0.8 cm compared with 3.3±0.6 cm, P=.102). There was a statistically significant difference in the perineal body with strain at 3 months compared with baseline (3.8±0.8 cm compared with 3.4±0.8 cm, P=.025).

Although there was not a difference in the genital hiatus at rest measured at enrollment between women with stage I/II prolapse and women with stage III/IV prolapse (2.9±0.8 cm and 3.5±1.2 cm, respectively, P=.218), there was a difference in genital hiatus with strain (3.8±1.0 cm and 5.1±1.6 cm, respectively, P=.031). However, there was no difference between these two groups of women in the change in genital hiatus at rest from baseline to 3 months (0.2±0.7 cm for stage I/II and 0.5±1.2 cm for stage III/IV, P=.470), or with strain (0.5±0.8 cm for stage I/II and 1.0±1.2 cm for stage III/IV, P=.244).

Using the mean baseline genital hiatus at rest of 3.4 cm as a cutpoint, we divided participants who continued pessary use into two groups: 3.4 cm or more and less than 3.4 cm baseline genital hiatus at rest. At 3 months, participants with 3.4 cm or more baseline genital hiatus at rest were noted to have a significantly greater change in genital hiatus at rest (1.0±1.0 cm compared with –0.2±0.9 cm, P=.002) and with strain (1.4±1.2 cm compared with 0.4±1.0 cm, P=.005), compared with those participants with less than 3.4 cm baseline genital hiatus at rest. The negative value obtained for change in genital at rest may be interpreted as essentially no clinically appreciable change with pessary use. This small negative value probably represents interobserver variability rather than a true increase in genital hiatus. Similarly, this may be due to the genital hiatus being slightly larger at the 3-month visit.

To determine which independent variables were predictive of continued pessary use, univariable analyses were performed. There were no statistically significant differences in age, parity, previous hysterectomy, menopausal status, pessary type, predominant compartment (leading edge of prolapse), genital hiatus, perineal body with strain, and total vaginal length between participants who continued and discontinued pessary use (Table 1). Statistically significant differences were noted in perineal body at rest, and POP-Q points Aa and Ba. However, from a multivariable logistic regression analysis, perineal body at rest and point Aa were the only independent predictors of continued use. Each 1-cm increase in baseline point Aa was associated with a 26% decrease in the likelihood of a participant discontinuing pessary use (odds ratio 0.743 P=.015, 95% confidence interval 0.584–0.945), indicating that women with larger baseline point Aa measurements were more likely to continue pessary use than women with smaller baseline measurements. Each 1-cm increase in baseline perineal body (at rest) was associated with a 92% increased risk of discontinuing pessary use (odds ratio 1.921, 95% confidence interval 1.055–3.496, P=.033), indicating that women with larger baseline measurements were more likely to discontinue pessary use than women with smaller baseline measurements.

The greatest change in the genital hiatus was noted with use of the Gellhorn (Table 3). After 3 months of consistent pessary use, there was on average a 0.3±1.0 cm and 1.1±1.2 cm (P=.056) decrease in genital hiatus at rest with the ring and Gellhorn, respectively. Similarly, the average decrease in genital hiatus with strain was 0.4±0.9 cm with the ring and 1.8±1.3 cm with the Gellhorn (P=.003). The ring pessary resulted in a smaller improvement in the size of the genital hiatus. The magnitude of this change was larger with strain measurements. There was no statistically significant change in the genital hiatus when the incontinence ring was used.

Table 3

Table 3

Changes in Pelvic Floor Distress Inventory questionnaire scores for participants continuing pessary use at 2 weeks and 3 months follow-up visits are depicted in Table 4. There was no significant difference in baseline Pelvic Organ Prolapse Distress Inventory for participants who continued (74±49) compared with those who discontinued pessary use (87±62, P=.284). There was a significant difference from baseline in overall Pelvic Floor Distress Inventory scores after 2 weeks and 3 months of consistent pessary use. There was a significant difference in all subscales with the exception of Colorectal Distress Inventory at these follow-up intervals. Participants with milder prolapse did not experience early subjective urinary and prolapse symptom relief comparable to women with severe prolapse. The 2-week Urinary Distress Inventory and Pelvic Organ Prolapse Distress Inventory scores were higher in stage I/II than those with stage III/IV prolapse (P<.05). The decrease in 2-week Pelvic Organ Prolapse Distress Inventory score was only 15±32 for participants with stage I/II prolapse and 42±52 for participants with stage III/IV prolapse, P=.053. This decrease in Pelvic Organ Prolapse Distress Inventory score was observed regardless of pessary continuation status.

Table 4

Table 4

There was no correlation between change in genital hiatus at rest and with strain and overall change in Pelvic Floor Distress Inventory score from baseline to 3 months (r=0.171, P=.284 (rest) and r=0.186, P=.238 (strain). Interestingly, there was a correlation between decrease in genital hiatus (from baseline to 3 months) with strain and decrease in Pelvic Organ Prolapse Distress Inventory scores (r=0 .308, P=.047). This positive correlation suggests that participants achieved more symptom relief with larger decreases in genital hiatus with strain (from 3 months to baseline).

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DISCUSSION

Previous studies have shown that long-term pessary use is a safe, effective option for treatment of patients with pelvic organ prolapse,6–10 resulting in significant improvement in symptoms.10 Successful pessary fitting rates range from 41–73%.9,11,12 Factors associated with unsuccessful fitting include shortened total vaginal length (less than 6 cm) and wide vaginal introitus (four finger breadths or more).12 Similarly, successful retention of a pessary has been associated with hormone use13 and sexual activity.14

In this study, we found no significant differences in the participants who continued pessary use and those that discontinued pessary use with respect to menopausal status, age, prolapse severity, previous hysterectomy, or number of pessaries fitted. Participants electing surgery were slightly older than those choosing to continue pessary use.

There was an improvement (or decrease) in genital hiatus at rest and with strain measurements using the POP-Q after 3 months of pessary use. Furthermore, patients with a larger genital hiatus size at baseline had a larger improvement with continued pessary use. For patients with a baseline genital hiatus at rest 3.4 cm or more, the mean of our study population, there were significantly greater improvements at the 3-month endpoint for genital hiatus measurements, both at rest and with strain, when compared with the less than 3.4 cm group. With respect to pessary type, the greatest difference in genital hiatus size, at both rest and strain, occurred in patients wearing a Gellhorn pessary. This may be a result of the improved load support provided by the Gellhorn pessary. Interestingly, more women that were fitted with incontinence ring discontinued pessary use. One could speculate that the presence and possibly the incomplete relief of one or both symptoms, was an incentive to pursue surgery.

Pelvic Organ Prolapse Quantification system point Aa was positively associated with continued pessary use. This may be explained by the observation that anterior-predominant vaginal prolapse is more easily addressed with a pessary as compared with posterior-predominant prolapse. An increase in the size of the perineal body was associated with discontinued use. We speculate that with detachment of the perineal body from the rectovaginal septum resulting in a larger perineal body, anatomically, patients are less likely to retain pessaries or may experience more discomfort from pessary use.

We expected to find a relationship between genital hiatus size and continued pessary use; however, we did not find the size of the genital hiatus to be an independent predictor of success. The size of the genital hiatus has been previously shown in the literature not to affect success of pessary fitting.11 One may postulate that the size of the hiatus would correlate with increased levator injury, and the magnitude of this injury should influence the success of reduction of prolapse with pessary use. However, previous studies have shown that levator ani strength, as assessed by the Oxford scale, does not correlate with short-term success of continued pessary use.11

Similar to a recent study by Cundiff et al,10 we found a significant difference in symptoms related to bother assessed by the Pelvic Floor Distress Inventory, after three months of pessary use. The results of this study will allow clinicians to better counsel patients regarding expectations regarding prolapse symptom relief. Patients may experience immediate symptom relief and consistent pessary use may effect lasting anatomical change that varies with pessary type.

Our study has both strengths and weaknesses. The main strength of our study is that we prospectively followed women choosing pessary therapy over a 3-month period with standardized questionnaires and the POP-Q examination. Thus, we were able to assess within-subject change in symptoms and POP-Q measurements between time points. We found a significant difference in the size of the genital hiatus in patients using the Gellhorn compared with the ring pessary, even though this study was not originally designed or powered to detect a difference by pessary type. The actual difference in genital hiatus with strain was roughly 1 cm after 3 months of pessary use. Previous literature has shown that interobserver variability for the POP-Q varies from .04 to .40 cm. Similarly, intraobserver variability was found to be 0.20 cm and 0.60 cm.15 The difference found in the genital hiatus in this study was larger than the variability between and within examiners, as previously documented in the literature. We believe the change in genital hiatus found in this study is significant and worth reporting. The weakness of our study is that the results are based on a small number of patients who may not be representative of all women with prolapse. In our study, stratification by prolapse severity did not result in any significant differences between moderate and severe prolapse patients with respect to the change in genital hiatus measurements; however, we acknowledge that the necessary sample size (n=18) was not achieved. In addition, we did not correlate specific changes in the levator ani with changes in the genital hiatus because imaging studies were not part of this protocol. Our results suggest that continued pessary use may result in some degree of recovery of the levator ani and hence a decrease in the size of the genital hiatus in women with prolapse. It is not clear whether this represents a long-term tissue remodeling effect due to the absence of mechanical stresses associated with prolapse or simply a physical effect in which the muscles are relieved of the structure (prolapse) contributing to widening of the levator hiatus. Either way, it is likely that pessaries reduce the load of the prolapsed vagina/pelvic organs on the levator ani muscles and perineum, allowing for tissue recovery resulting in a smaller genital hiatus.

It has been shown that continued pessary use can slow progression of prolapse and may aid in halting the progression of the disease.6 Perhaps a pessary can be thought of as a device that may be worn prophylactically to slow progression of disease. In our study, the genital hiatus is size was significantly reduced, suggesting a possible mechanism to halt or slow progression of prolapse. Clinicians may be able to use this information to encourage continued pessary use in treatment of and, possibly prevention of, pelvic organ prolapse progression. In addition, this study adds more information to the literature confirming pelvic floor symptoms improvement with pessary use.

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© 2008 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.