Self-management Pessary Project
ZPP
Dutch Title: Zelfmanagement Pessarium Project
1 other identifier
observational
288
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 9, 2023
CompletedFirst Submitted
Initial submission to the registry
May 11, 2023
CompletedFirst Posted
Study publicly available on registry
June 2, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedJune 2, 2023
May 1, 2023
2 years
May 11, 2023
June 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients that succeed in learning self-management of the 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.
immediately after self-management training, it is determined whether patients can remove and insert their pessary
Interventions
self-managing a pessary: removing, cleaning and inserting
Eligibility Criteria
New patients that get fitted a pessary in second line (hospital)
You may qualify if:
- fitted a ring, sieve of knob pessary
- above 18 years old
- able to understand patient information
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zuyderland Medisch Centrum
Heerlen, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
M Weemhoff
Zuyderland Medisch Centrum
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2023
First Posted
June 2, 2023
Study Start
January 9, 2023
Primary Completion
January 1, 2025
Study Completion
March 1, 2025
Last Updated
June 2, 2023
Record last verified: 2023-05