NCT03615872

Pessary Satisfaction Criteria for Urogenital Prolapse

Evaluation of Patient Satisfaction With Pessary in the Treatment of Genital Prolapse

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: University Hospital, Caen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Genital Prolapse
• Pessary
• Satisfaction

Interventions

Type	Name	Description
DEVICE	pessary use	evaluation of satisfaction of pessary use in case of symptomatic genital prolapse

Timeline

• Start date: 2018-06-20
• Primary completion: 2018-06-20
• Completion: 2025-06-01
• First posted: 2018-08-06
• Last updated: 2024-09-20

Locations

1 site across 1 country: France