RecruitingNCT04701047

Prospective Observational Prolapse Study

Prospective Observational Study with Patient Reported Outcome Measures (PROM) for the Treatment of Vaginal Prolapse: Pessary Vs. Surgery

Sponsor

University Hospital, Ghent

Enrollment

200 participants

Start Date

Sep 3, 2021

Study Type

OBSERVATIONAL

Conditions

Vaginal prolapse

Summary

The rationale of the study is to investigate the results of a prolapse treatment in adult women with a vaginal prolapse. The investigators will investigate this by taking questionnaires in women undergoing a surgical prolapse repair and in women that are being treated by a vaginal pessary. The objective is to compare the results of the different methods with each other and to observe the evolution of the symptoms in patients undergoing surgery or pessary use. The investigators would also like to discover existing problems in pessary use and adverse effects.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Vaginal prolapse surgery and a medical device called vaginal pessary for people with vaginal prolapse. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEvaginal pessary

insertion and follow up of a vaginal pessary

PROCEDUREVaginal prolapse surgery

surgery and follow up after vaginal prolapse surgery

Locations(1)

Ghent University Hospital

Ghent, Belgium

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NCT04701047

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