Pelvic Organ Prolapse
Conditions
Keywords
pelvic organ prolapse, pessary, self-management
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.
Interventions
OTHERself-management
self-managing a pessary: removing, cleaning and inserting
Sponsors
Zuyderland Medisch Centrum
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Netherlands
Contacts
Primary ContactM Weemhoff, MD, PhD
Backup ContactResearch Nurses
Outcome results
None listed