Self-management Pessary Project

Recruiting

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT05885711
• Lead Sponsor: Zuyderland Medisch Centrum

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-09
• Status Verified: 2023-05
• Study First Submitted: 2023-05-11
• Study First Submitted QC: 2023-06-01
• Last Update Submitted: 2023-06-01
• Study First Posted: 2023-06-02
• Last Update Posted: 2023-06-02
• Primary Completion: 2025-01-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 288

Inclusion Criteria

• fitted a ring, sieve of knob pessary
• above 18 years old
• able to understand patient information

Exclusion Criteria

• fitted a new pessary to replace an old one (continuing former pessary therapy)
• fitted a new pessary after they experienced adverse effects of a former pessary

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients that succeed in learning self-management of the pessary	immediately after self-management training, it is determined whether patients can remove and insert their pessary	Patients were offered self-management training, after explanation they were asked to remove and insert their pessary twice. Succes was defined as removing and inserting the pessary completely independent the second time.

Trial Locations

Locations (1)

Zuyderland Medisch Centrum; 🇳🇱 Heerlen, Netherlands