Self-management Pessary Project (ZPP)

Zuyderland Medisch Centrum

Status: Enrolling

Conditions: Pelvic Organ Prolapse

Treatments: Other: self-management

Study type: Observational

Funder types: Other

Identifiers

NCT05885711

Z2022098

Details and patient eligibility

About

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.

Enrollment: 288 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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