MedTrace Logo

Self-management Pessary Project

NCT05885711 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 288

Last updated 2023-06-02

No results posted yet for this study

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

OTHER

self-management

self-managing a pessary: removing, cleaning and inserting

Sponsors & Collaborators

  • Zuyderland Medisch Centrum

    lead OTHER

Principal Investigators

  • M Weemhoff · Zuyderland Medisch Centrum

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-09
Primary Completion
2025-01-01
Completion
2025-03-01

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05885711 on ClinicalTrials.gov