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

NCT ID: NCT05778552

Last Updated: 2023-03-21

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-01

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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The investigators will enroll participants with SUI or POP and allocate them into either the home-based pelvic floor muscle training (PFMT) group or traditional PFMT group. Participant satisfaction will be evaluated using a questionnaire score.

Conditions

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Pelvic Floor Disorders Pelvic Organ Prolapse Stress Urinary Incontinence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Home-based pelvic muscle training devices group

Patients underwent pelvic muscle training by home-based device and at home.

Home-based pelvic muscle training devices or traditional PFMT at hospital

Intervention Type DEVICE

Performed home-based pelvic muscle training devices at home or traditional PFMT at hospital

Traditional pelvic muscle training devices group

Patients underwent traditional pelvic muscle training at hospital

Home-based pelvic muscle training devices or traditional PFMT at hospital

Intervention Type DEVICE

Performed home-based pelvic muscle training devices at home or traditional PFMT at hospital

Interventions

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Home-based pelvic muscle training devices or traditional PFMT at hospital

Performed home-based pelvic muscle training devices at home or traditional PFMT at hospital

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Huann-Cheng Horng

Role: PRINCIPAL_INVESTIGATOR

Taipei Veterans General Hospital, Taiwan

Locations

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Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Huann-Cheng Horng

Role: CONTACT

[email protected]
886-(2) 2875-7826

Facility Contacts

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Huann-Cheng Horng, MD, PhD

Role: primary

[email protected]
886-(2) 2875-7826

Other Identifiers

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2022-10-004A

Identifier Type: -

Identifier Source: org_study_id

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