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.
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.
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).
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.
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