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NCT05778552 Clinical Trial

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

Pelvic Organ Prolapse Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05778552
Other study ID # 2022-10-004A
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date December 31, 2026

Study information
Verified date March 2023
Source Taipei Veterans General Hospital, Taiwan
Contact Huann-Cheng Horng
Phone 886-(2) 2875-7826
Email hchorng@vghtpe.gov.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 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

Locations
Country Name City State
Taiwan Taipei Veterans General Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary The satisfication of pelvic muscle training (UDI-6) The total score ranges from 0 to 18, with a higher score indicating that the patient experiences a greater degree of urinary distress. up to 2 years
Primary The satisfication of pelvic muscle training (ICIQ-SF) The total score ranges from 0 to 21, with a higher score indicating that the patient experiences a greater degree of urinary distress. up to 2 years
Primary The satisfication of pelvic muscle training (IIQ-7) The total score ranges from 0 to 21, with a higher score indicating that the patient experiences a greater degree of urinary distress. up to 2 years
Primary The satisfication of pelvic muscle training (POPDI-6) POPDI-6 scores range from 0 to 24 and higher scores indicate worse bulging symptoms up to 2 years
Primary The satisfication of pelvic muscle training (PISQ-IR) The 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. up to 2 years
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