ZPP: Self-management Pessary Project

Zuyderland Medisch Centrum (Other)
Overall Status
CT.gov ID

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: self-management

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
288 participants
Observational Model:
Time Perspective:
Official Title:
Dutch Title: Zelfmanagement Pessarium Project
Actual Study Start Date :
Jan 9, 2023
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Mar 1, 2025

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations


Site City State Country Postal Code
1 Zuyderland Medisch Centrum Heerlen Netherlands

Sponsors and Collaborators

  • Zuyderland Medisch Centrum


  • Principal Investigator: M Weemhoff, Zuyderland Medisch Centrum

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Zuyderland Medisch Centrum
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • Z2022098
First Posted:
Jun 2, 2023
Last Update Posted:
Jun 2, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Zuyderland Medisch Centrum
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 2, 2023