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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05778552
Enrollment
200
Registered
2023-03-21
Start date
2023-04-01
Completion date
2026-12-31
Last updated
2023-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Floor Disorders, Pelvic Organ Prolapse, Stress Urinary Incontinence

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.

Detailed description

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.

Interventions

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

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

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The satisfication of pelvic muscle training (UDI-6)up to 2 yearsThe total score ranges from 0 to 18, with a higher score indicating that the patient experiences a greater degree of urinary distress.
The satisfication of pelvic muscle training (ICIQ-SF)up to 2 yearsThe total score ranges from 0 to 21, with a higher score indicating that the patient experiences a greater degree of urinary distress.
The satisfication of pelvic muscle training (IIQ-7)up to 2 yearsThe total score ranges from 0 to 21, with a higher score indicating that the patient experiences a greater degree of urinary distress.
The satisfication of pelvic muscle training (POPDI-6)up to 2 yearsPOPDI-6 scores range from 0 to 24 and higher scores indicate worse bulging symptoms
The satisfication of pelvic muscle training (PISQ-IR)up to 2 yearsThe PISQ-IR is a validated questionnaire in research for assessment of female sexual function. A higher score indicates a greater negative impact on sexual function.

Countries

Taiwan

Contacts

Primary ContactHuann-Cheng Horng
hchorng@vghtpe.gov.tw886-(2) 2875-7826

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026