The Intermediate and Long-term Follow up of Home Based Pelvic Muscle Training
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Home-based pelvic muscle training devices group Patients underwent pelvic muscle training by home-based device and at home. |
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
|
| Traditional pelvic muscle training devices group Patients underwent traditional pelvic muscle training at hospital |
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
|
Outcome Measures
Primary Outcome Measures
- The satisfication of pelvic muscle training (UDI-6) [up to 2 years]
The 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 years]
The 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 years]
The 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 years]
POPDI-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 years]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Taipei Veterans General Hospital | Taipei | Taiwan | 112 |
Sponsors and Collaborators
- Taipei Veterans General Hospital, Taiwan
Investigators
- Principal Investigator: Huann-Cheng Horng, Taipei Veterans General Hospital, Taiwan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-10-004A