NCT05885711

Self-management Pessary Project

Dutch Title: Zelfmanagement Pessarium Project

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 288 (estimated)
• Sponsor: Zuyderland Medisch Centrum · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

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.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
OTHER	self-management	self-managing a pessary: removing, cleaning and inserting

Timeline

• Start date: 2023-01-09
• Primary completion: 2025-01-01
• Completion: 2025-03-01
• First posted: 2023-06-02
• Last updated: 2023-06-02

Locations

1 site across 1 country: Netherlands