Prospective Observational Study Comparing Vaginal Pessary and Surgery for Vaginal Prolapse with Patient-Reported Outcome Measures and Long-Term Follow-Up

What this Trial Is About

This research aims to evaluate the outcomes of treatments for vaginal prolapse in adult women. The study compares surgical prolapse repair with treatment using a vaginal pessary, focusing on the progression of symptoms and any problems or side effects related to pessary use. The study collects patient-reported outcome measures to better understand the impact of these treatments over time. Participants will either undergo vaginal prolapse surgery or have a vaginal pessary inserted and followed up. Questionnaires assessing pelvic floor distress, pelvic floor impact, sexual function, and specific experiences with pessary use will be completed before treatment, at 6 weeks, 1 year, 2 years, and 5 years after starting treatment. Women using pessaries will also complete additional questionnaires at 4 and 8 months. A clinical evaluation of prolapse severity will be done before treatment begins. Women taking part in the study will fill out several questionnaires at scheduled times, some by phone or email after surgery. The investigators will track changes in pelvic floor symptoms and sexual function using standardized questionnaires over five years. The study aims to enroll 100 women over 18 years old who have not previously been treated for vaginal prolapse and can give written consent. Safety and symptom changes will be monitored throughout the follow-up period.

Prospective Observational Prolapse Study