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Clinical Trial Summary

The goal of this multicenter observational study is to study self-management of pessary therapy in patients with pelvic organ prolapse. The primary question it aims to answer is: • how many patients succeed learning self-management if offered a standardized training? Secondary outcomes are: - how many patients are willing to learn self-management? - what patient factors contribute to successfully learning self-management and willingness to self-manage? - how satisfied are patients with pessary therapy and self-management? - the occurrence of side-effects - continuation and quitting of pessary therapy and self-management - cross-over to surgery - number of visits to doctor because of pessary therapy - healthcare costs Participants will be asked to fill in questionnaires three times during the study (upon inclusion, 6 weeks and 12 months after starting self-management or after starting pessary therapy with a correctly fitting pessary). Researchers will compare the self-managing patient to the non-self-managing patients.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05885711
Study type Observational [Patient Registry]
Source Zuyderland Medisch Centrum
Contact M Weemhoff, MD, PhD
Phone 088 4596146
Email zpp@zuyderland.nl
Status Recruiting
Phase
Start date January 9, 2023
Completion date March 1, 2025

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