Patient Satisfaction Study of Pessary Use for Symptomatic Genital Prolapse A 5-Year Observational Evaluation at University Hospital Caen

What this Trial Is About

Researchers are evaluating patient satisfaction with the use of pessaries for treating symptomatic genital prolapse. This observational study is conducted at the University Hospital of Caen and aims to understand satisfaction within the first year after pessary placement, as well as over a five-year period. The study also investigates the impact of factors such as age, menopausal status, weight, hysterectomy history, prolapse surgery history, and prolapse stage on pessary removal or expulsion. Participants will be offered pessary installation and asked to complete a series of validated questionnaires assessing symptoms, sexual function, quality of life, and satisfaction. These questionnaires include the PFDI-20, ICIQ-SF, USP, PISQ-12, PFIQ-7, BIS, and the PGI-I for satisfaction. Assessments take place before pessary placement, then at one month, six months, and annually for up to five years. During the study, participants will complete symptom and quality of life questionnaires multiple times to track changes and satisfaction with the pessary over time. Researchers will monitor complications and explore how patient characteristics affect pessary use. The primary outcome is patient satisfaction measured by the PGI-I score at one year, with additional annual assessments up to five years, allowing for long-term observation of outcomes and device performance.

Pessary Satisfaction Criteria for Urogenital Prolapse