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

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

Inclusion Criteria2

  • women with a symptomatic vaginal prolapse
  • older than 18 years

Exclusion Criteria6

  • under 18 years old
  • undergone a previous treatment with a pessary or surgery for vaginal prolapse
  • contra-indications for surgery or pessary use
  • active or passive child wish
  • not able to understand the Dutch language
  • not able to give a written consent

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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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