Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
288 participants
OBSERVATIONAL
2023-01-09
2025-03-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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self-management
self-managing a pessary: removing, cleaning and inserting
Eligibility Criteria
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Inclusion Criteria
* above 18 years old
* able to understand patient information
Exclusion Criteria
* fitted a new pessary after they experienced adverse effects of a former pessary
18 Years
FEMALE
No
Sponsors
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Zuyderland Medisch Centrum
OTHER
Responsible Party
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Principal Investigators
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M Weemhoff
Role: PRINCIPAL_INVESTIGATOR
Zuyderland Medisch Centrum
Locations
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Zuyderland Medisch Centrum
Heerlen, , Netherlands
Countries
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Central Contacts
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Research Nurses
Role: CONTACT
Facility Contacts
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Other Identifiers
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Z2022098
Identifier Type: -
Identifier Source: org_study_id
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