The Intermediate and Long-term Follow up of Home Based Pelvic Muscle Training
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorTaipei Veterans General Hospital, Taiwan
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age > 18-year-old, non-pregnancy, SUI, bladder capacity > 300ml, RU<150ml, pelvic organ prolapse
Disqualifiers
recurrent UTI, cancer patients, chronic pelvic pain, psychologic problems
Trial population
Women with SUI and Pelvic organ prolapse could be enrolled for study
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Home-based pelvic muscle training devices or traditional PFMT at hospital
DevicePerformed home-based pelvic muscle training devices at home or traditional PFMT at hospital
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Home-based pelvic muscle training devices group1 intervention
Group B: Traditional pelvic muscle training devices group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
up to 2 years2
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.
Time frame
up to 2 years3
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.
Time frame
up to 2 years4
The satisfication of pelvic muscle training (POPDI-6)
POPDI-6 scores range from 0 to 24 and higher scores indicate worse bulging symptoms
Time frame
up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov