Self-management Pessary Project

Pelvic Organ Prolapse Clinical Trial

— ZPP  

Official title:

Dutch Title: Zelfmanagement Pessarium Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05885711
• Other study ID #: Z2022098
• Status: Recruiting
• Start date: January 9, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: May 2023
• Source: Zuyderland Medisch Centrum
• Contact: M Weemhoff, MD, PhD
• Phone: 088 4596146
• Email: zpp[@]zuyderland.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 288
• Est. completion date: March 1, 2025
• Est. primary completion date: January 1, 2025
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Other:
• self-management
self-managing a pessary: removing, cleaning and inserting

Locations

Country	Name	City	State
Netherlands	Zuyderland Medisch Centrum	Heerlen

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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