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Clinical Trial Summary

Genital prolapse is a common pathology with a prevalence ranging from 2.9 to 11.4% or 31.8% to 97.7%, depending on whether a questionnaire or clinical examination is used. The use of pessary in the treatment of prolapse remains discussed despite a satisfaction rate of 50 to 80% in the literature and a minimal complications rate. The main objective of this study is to assess the satisfaction of patients carrying a pessary in the first year after the laying.


Clinical Trial Description

This is a prospective observational cohort conducted at the Universitary hospital of Caen over a total period of 5 years. Patients with a symptomatic genital prolapse will all be offered the installation of a pessary. If they agree to participate in the study, they will be asked to respond to validated questionnaires: symptom questionnaires (PFDI-20, ICIQ-SF, USP), a sexuality questionnaire (PISQ-12), a quality of life questionnaire (PFIQ-7, BIS) and Satisfaction (PGI-I), several times: Before the installation of the pessary, at one month, at 6 months, then annually over 5 years ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03615872
Study type Observational [Patient Registry]
Source University Hospital, Caen
Contact Anne Cecile PIZZOFERRATO, MD
Phone +33231272723
Email acpizzofe@gmail.com
Status Recruiting
Phase
Start date June 20, 2018
Completion date June 2023

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