Surgery better than Pessary treatment for Symptomatic Pelvic Organ Prolapse: PEOPLE study
Symptomatic pelvic organ prolapse (POP), is a common problem in women, with an estimated prevalence of 8.3 - 12.1% and peak incidence in women aged 60-69. Although not life-threatening, POP negatively affects the quality of life due to micturition and defecatory symptoms, vaginal bulging and sexual disorders.
Several treatment options are available for POP, ranging from conservative measures like life-style advice, pelvic floor physiotherapy and pessary therapy, to surgery as a more invasive option. The choice between pessary and surgery depends on both doctor as well as patient preferences. A survey showed that 69% of gynaecologists always informed their patients about pessary therapy, 17% sometimes and 14% never.
Regarding treatment goals, women having surgery of pessary reported the same treatment goal, namely to improve prolapse symptoms. Beside the positive effects of both treatments in improving POP symptoms, either has disadvantages. Side-effects of surgery include de novo stress urinary incontinence, recurrence of POP, de novo dyspareunia and a reoperation rate. Adverse events of pessary treatment may occur in up to 54% of women and include pessary expulsion, discomfort, pressure ulcer, micturition disorders and vaginal discharge. After 24-months 24.5 – 36.0% of women stopped using a pessary.
The aim of multicentre prospective cohort study by Lisa R. van der Vaart and team with a 24-months follow-up, was to compare efficacy between pessary and surgery in women with symptomatic POP in terms of patient satisfaction.
The primary outcome was subjective improvement at 24-months 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 cross-over between therapies. The primary safety outcome was the occurrence of adverse events.
- Study included 539 women, 335 (62.2%) in the pessary arm and 204 (37.8%) in the surgery arm.
- After 24-months, subjective improvement was reported by 134 (83.8%) women in the surgery group as compared to 180 (74.4%) in the pessary group (risk difference 9.4%; p<0.01).
- Seventy-nine (23.6%) women switched from pessary to surgery and 22 (10.8%) women in the surgery group underwent additional treatment.
- Both groups showed a significant reduction in bothersome POP symptoms (p≤0.01) and reduction in the perceived severity of symptoms (p≤0.001) compared to baseline.
This study shows that surgery, in comparison to pessary treatment, resulted in statistically significant more women reporting subjective improvement. One out of five women switched from pessary to surgery within 24-months. However, both interventions showed significant reductions of presence and severity of prolapse symptoms. Surgery was more effective on secondary outcomes, as shown by significant reductions on the PGI-S and PFDI-20 scales.
Women opting for surgery are significantly younger, had a higher BMI and experience more bothersome symptoms at baseline. Apparently, women who experienced more bothersome symptoms are more likely to choose for surgery.
Women who opt for surgery, compared to pessary, improved better regarding their prolapse, bowel and urinary-distress symptoms and more often report a subjective improvement in quality of life. However, women should be counselled that approximately 1 out of 13 will undergo re-operation, which is in line with previous finding. Main reasons for re-operation are recurrence of prolapse and/or SUI. In order to make a well-balanced decision, it is important to emphasize that while pessary is less effective than surgery it does constitute an effective treatment option and should be proposed to women considering surgery.
With respect to the UDI-6 scale, the surgery group showed statistically significant more reduction on urinary symptoms. Focusing on the subscales of the UDI-6, the surgery group showed statistically significant more improvement on obstructive and irritative symptoms.
In case of predominant prolapse symptoms, both therapies showed a clinical important improvement and can be advised as primary treatment. In case bothersome micturition and/or defecation symptoms coexist, surgery is more effective. Women should be counselled that after 24-months, 73% of women who continued pessary therapy, reported successful improvement as compared to 84% when having surgery. One out of five women who started with pessary therapy switched to surgery within 24-months because of side effects or insufficient symptom relief.
Source: Lisa R. van der Vaart, Astrid Vollebregt, Alfredo L. Milani; International Journal of Gynecology & Obstetrics
doi:10.1111/1471-0528.16950
