Recruiting NCT05778552

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

— Observational Pelvic Floor Disorders Pelvic Organ Prolapse Stress Urinary Incontinence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Home-based pelvic muscle training devices or traditional PFMT at hospital.
Who it may be relevant to: Registry conditions: Pelvic Floor Disorders, Pelvic Organ Prolapse, Stress Urinary Incontinence. Basic parameters: from 18 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Taiwan
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

The satisfication of pelvic muscle training (UDI-6) [Time frame: up to 2 years]
The satisfication of pelvic muscle training (ICIQ-SF) [Time frame: up to 2 years]
The satisfication of pelvic muscle training (IIQ-7) [Time frame: up to 2 years]
The satisfication of pelvic muscle training (POPDI-6) [Time frame: up to 2 years]
The satisfication of pelvic muscle training (PISQ-IR) [Time frame: up to 2 years]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model: Cohort

Study locations

Taiwan · 1 center

Taipei Veterans General Hospital — Taipei

Identifiers

NCT: NCT05778552 · 2022-10-004A

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗