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

Recruiting

• Conditions: Pelvic Floor Disorders; Pelvic Organ Prolapse; Stress Urinary Incontinence
• Interventions: Device: Home-based pelvic muscle training devices or traditional PFMT at hospital

• Registration Number: NCT05778552
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study First Submitted: 2023-02-20
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-09
• Last Update Submitted: 2023-03-09
• Study First Posted: 2023-03-21
• Last Update Posted: 2023-03-21
• Study Start: 2023-04-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Home-based pelvic muscle training devices group	Home-based pelvic muscle training devices or traditional PFMT at hospital	Patients underwent pelvic muscle training by home-based device and at home.
Traditional pelvic muscle training devices group	Home-based pelvic muscle training devices or traditional PFMT at hospital	Patients underwent traditional pelvic muscle training at hospital

Primary Outcome Measures

Name	Time	Method
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.
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 (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 (POPDI-6)	up to 2 years	POPDI-6 scores range from 0 to 24 and higher scores indicate worse bulging symptoms

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan