Pessary or surgery for a symptomatic pelvic organ prolapse: the PEOPLE study, a multicentre prospective cohort study

Abstract

Objective To compare the 24‐month efficacy of pessary or surgery as the primary treatment for symptomatic pelvic organ prolapse (POP). Design Multicentre prospective comparative cohort study. Setting Twenty‐two Dutch hospitals. Population Women referred with symptomatic POP of stage ≥2 and moderate‐to‐severe POP symptoms. Methods The primary outcome was subjective improvement at the 24‐month follow‐up according to the Patient Global Impression of Improvement (PGI‐I) scale. Secondary outcomes included improvement in prolapse‐related symptoms measured with the Pelvic Floor Distress Inventory (PFDI‐20), improvement in subjective severeness of symptoms according to the Patient Global Impression of Severity (PGI‐S) scale and crossover between therapies. The primary safety outcome was the occurrence of adverse events. Main outcome measure PGI‐I at 24 months. Results We included 539 women, with 335 women (62.2%) in the pessary arm and 204 women (37.8%) in the surgery arm. After 24 months, subjective improvement was reported by 134 women (83.8%) in the surgery group compared with 180 women (74.4%) in the pessary group (risk difference 9.4%, 95% CI 1.4–17.3%, P < 0.01). Seventy‐nine women (23.6%) switched from pessary to surgery and 22 women (10.8%) in the surgery group underwent additional treatment. Both groups showed a significant reduction in bothersome POP symptoms (P ≤ 0.01) and a reduction in the perceived severity of symptoms (P ≤ 0.001) compared with the baseline. Conclusions Significantly more women in the surgery group reported a subjective improvement after 24 months. Both therapies, however, showed a clinically significant improvement of prolapse symptoms. Tweetable abstract Pessary treatment and vaginal surgery are both efficacious in reducing the presence and severity of prolapse symptoms, although the chance of significant improvement is higher following surgery.

The Role of Self-Management in Pessary Therapy for Pelvic Organ Prolapse—A retrospective cohort study

“…This outcome can be attributed to the exclusion of patients with unsuccessful pessary fitting in our results. The prevalence of side effects in pessary treatment was similar to those found by Van der Vaart et al [3]. The number of patients with one or more side effects differed 13% between the PSM and CM groups, but in our sample size this difference was not significant.…”

“…Pessary fitting was successful in 75% of patients, which corresponds to several studies reporting pessary-fitting success rates at 77% and 71% [3,11]. The prevalence of PSM instructions and ability to perform PSM was also in line with previous research [11][12][13][14].…”

The Role of Self-Management in Pessary Therapy for Pelvic Organ Prolapse—A retrospective cohort study

“…This outcome can be attributed to the exclusion of patients with unsuccessful pessary fitting in our results. The prevalence of side effects in pessary treatment was similar to those found by Van der Vaart et al [3]. The number of patients with one or more side effects differed 13% between the PSM and CM groups, but in our sample size this difference was not significant.…”

“…Pessary fitting was successful in 75% of patients, which corresponds to several studies reporting pessary-fitting success rates at 77% and 71% [3,11]. The prevalence of PSM instructions and ability to perform PSM was also in line with previous research [11][12][13][14].…”

Quality of Life after Treatment for Pelvic Organ Prolapse in Real-World Study: Recommendations, Vaginal Pessary, and Surgery

“…The continuation rate at 24 months was 63.6% in the pessary group and 48% in the recommendations group. These findings are consistent with other studies, where the continuation of pessary treatment varies from 51-63% to 76-78.2% of women within 12 to 24 months [11,[13][14][15]26]. Overall, 14.3% of women from the recommendations group and 12.1% from the pessary group switched to another treatment (pessary or surgery) within 24 months, while the rest of the study participants discontinued the initial treatment without opting for any other POP treatment method.…”

“…However, women who continued primary pessary treatment reported a high PGI-I success rate of 90.5% at 24 months, which was similar to the PGI-I success rate in the surgery group (89.6%) and consistent with the results of some other studies [14,16]. The proportion of women indicating a subjective improvement with continued pessary use varied from 87.4% at 6 months to 74.4% at 24 months [14,16]. The differences among studies may be attributed to the characteristics of the women involved and the stage of prolapse.…”

“…The most common reasons for discontinuation or switching to another treatment method were inadequate symptom relief and a mismatch of expectations in the recommendations group, followed by excessive vaginal discharge, vaginal pain, discomfort, preference for surgery, and pessary expulsion in the pessary group, which are consistent with other studies [6,10,14,19,22,27]. In our study, we did not undertake follow-up visits with the women; this is why we could not encourage them to carry out further pelvic floor muscle training or adhere to lifestyle changes.…”

The Role of Self-Management in Pessary Therapy for Pelvic Organ Prolapse—A retrospective cohort study

“…This outcome can be attributed to the exclusion of patients with unsuccessful pessary fitting in our results. The prevalence of side effects in pessary treatment was similar to those found by Van der Vaart et al [3]. The number of patients with one or more side effects differed 13% between the PSM and CM groups, but in our sample size this difference was not significant.…”

“…Pessary fitting was successful in 75% of patients, which corresponds to several studies reporting pessary-fitting success rates at 77% and 71% [3,11]. The prevalence of PSM instructions and ability to perform PSM was also in line with previous research [11][12][13][14].…”

Quality of Life after Treatment for Pelvic Organ Prolapse in Real-World Study: Recommendations, Vaginal Pessary, and Surgery

“…The continuation rate at 24 months was 63.6% in the pessary group and 48% in the recommendations group. These findings are consistent with other studies, where the continuation of pessary treatment varies from 51-63% to 76-78.2% of women within 12 to 24 months [11,[13][14][15]26]. Overall, 14.3% of women from the recommendations group and 12.1% from the pessary group switched to another treatment (pessary or surgery) within 24 months, while the rest of the study participants discontinued the initial treatment without opting for any other POP treatment method.…”

“…However, women who continued primary pessary treatment reported a high PGI-I success rate of 90.5% at 24 months, which was similar to the PGI-I success rate in the surgery group (89.6%) and consistent with the results of some other studies [14,16]. The proportion of women indicating a subjective improvement with continued pessary use varied from 87.4% at 6 months to 74.4% at 24 months [14,16]. The differences among studies may be attributed to the characteristics of the women involved and the stage of prolapse.…”

“…The most common reasons for discontinuation or switching to another treatment method were inadequate symptom relief and a mismatch of expectations in the recommendations group, followed by excessive vaginal discharge, vaginal pain, discomfort, preference for surgery, and pessary expulsion in the pessary group, which are consistent with other studies [6,10,14,19,22,27]. In our study, we did not undertake follow-up visits with the women; this is why we could not encourage them to carry out further pelvic floor muscle training or adhere to lifestyle changes.…”

The Role of Self-Management in Pessary Therapy for Pelvic Organ Prolapse—A retrospective cohort study

“…This outcome can be attributed to the exclusion of patients with unsuccessful pessary fitting in our results. The prevalence of side effects in pessary treatment was similar to those found by Van der Vaart et al [3]. The number of patients with one or more side effects differed 13% between the PSM and CM groups, but in our sample size this difference was not significant.…”

“…Pessary fitting was successful in 75% of patients, which corresponds to several studies reporting pessary-fitting success rates at 77% and 71% [3,11]. The prevalence of PSM instructions and ability to perform PSM was also in line with previous research [11][12][13][14].…”

Quality of Life after Treatment for Pelvic Organ Prolapse in Real-World Study: Recommendations, Vaginal Pessary, and Surgery

“…The continuation rate at 24 months was 63.6% in the pessary group and 48% in the recommendations group. These findings are consistent with other studies, where the continuation of pessary treatment varies from 51-63% to 76-78.2% of women within 12 to 24 months [11,[13][14][15]26]. Overall, 14.3% of women from the recommendations group and 12.1% from the pessary group switched to another treatment (pessary or surgery) within 24 months, while the rest of the study participants discontinued the initial treatment without opting for any other POP treatment method.…”

“…However, women who continued primary pessary treatment reported a high PGI-I success rate of 90.5% at 24 months, which was similar to the PGI-I success rate in the surgery group (89.6%) and consistent with the results of some other studies [14,16]. The proportion of women indicating a subjective improvement with continued pessary use varied from 87.4% at 6 months to 74.4% at 24 months [14,16]. The differences among studies may be attributed to the characteristics of the women involved and the stage of prolapse.…”

“…The most common reasons for discontinuation or switching to another treatment method were inadequate symptom relief and a mismatch of expectations in the recommendations group, followed by excessive vaginal discharge, vaginal pain, discomfort, preference for surgery, and pessary expulsion in the pessary group, which are consistent with other studies [6,10,14,19,22,27]. In our study, we did not undertake follow-up visits with the women; this is why we could not encourage them to carry out further pelvic floor muscle training or adhere to lifestyle changes.…”