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

Taipei Veterans General Hospital

Status: Enrolling

Conditions: Pelvic Floor Disorders; Stress Urinary Incontinence; Pelvic Organ Prolapse

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

Study type: Observational

Funder types: Other

Identifiers

NCT05778552

2022-10-004A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Home-based pelvic muscle training devices group

Description:

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

Treatment:

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

Traditional pelvic muscle training devices group

Description:

Patients underwent traditional pelvic muscle training at hospital

Treatment:

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