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Recruiting NCT05778552

NCT05778552 The Intermediate and Long-term Follow up of Home Based Pelvic Muscle Training

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Clinical Trial Summary
NCT ID NCT05778552
Status Recruiting
Phase
Sponsor Taipei Veterans General Hospital, Taiwan
Condition Pelvic Floor Disorders
Study Type OBSERVATIONAL
Enrollment 200 participants
Start Date 2023-04-01
Primary Completion 2025-12-31

Trial Parameters

Condition Pelvic Floor Disorders
Sponsor Taipei Veterans General Hospital, Taiwan
Study Type OBSERVATIONAL
Phase N/A
Enrollment 200
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2023-04-01
Completion 2025-12-31
Interventions
Home-based pelvic muscle training devices or traditional PFMT at hospital

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Brief Summary

When participants present with symptoms of pelvic organ prolapse (POP) and stress urinary incontinence (SUI), the investigators will perform a comprehensive evaluation and initially provide conservative treatment. If conservative treatment fails, invasive treatment will be considered. The investigators will arrange a pelvic muscle training course two to three times a week for a duration of 1.5 months per course. However, participants may complain about the inconvenience of traffic, which may lead to discontinuation of the pelvic training course. Therefore, the investigators propose the development of a home-based pelvic muscle training device and will collaborate with information engineering specialists at Tamkang University to invent the device for home-based pelvic muscle training.

Eligibility Criteria

Inclusion Criteria: * Age \> 18-year-old, non-pregnancy, SUI, bladder capacity \> 300ml, RU\<150ml, pelvic organ prolapse Exclusion Criteria: * recurrent UTI, cancer patients, chronic pelvic pain, psychologic problems

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