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RECRUITING
NCT04701047

Prospective Observational Prolapse Study

Sponsor: University Hospital, Ghent

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2021-09-03

Completion Date

2028-01

Last Updated

2025-01-15

Healthy Volunteers

No

Interventions

DEVICE

vaginal pessary

insertion and follow up of a vaginal pessary

PROCEDURE

Vaginal prolapse surgery

surgery and follow up after vaginal prolapse surgery

Locations (1)

Ghent University Hospital

Ghent, Belgium