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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pelvic Floor Disorders, Pelvic Organ Prolapse, Stress Urinary Incontinence

Intervention / Treatment
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* Device: Home-based pelvic muscle training devices or traditional PFMT at hospital


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Home-based pelvic muscle training devices group<br>Patients underwent pelvic muscle training by home-based device and at home. | Device: Home-based pelvic muscle training devices or traditional PFMT at hospital<br>* Performed home-based pelvic muscle training devices at home or traditional PFMT at hospital<br>|
| Traditional pelvic muscle training devices group<br>Patients underwent traditional pelvic muscle training at hospital | Device: Home-based pelvic muscle training devices or traditional PFMT at hospital<br>* Performed home-based pelvic muscle training devices at home or traditional PFMT at hospital<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 2 years | 
| 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. | up to 2 years | 
| 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. | up to 2 years | 
| The satisfication of pelvic muscle training (POPDI-6) | POPDI-6 scores range from 0 to 24 and higher scores indicate worse bulging symptoms | up to 2 years | 
| The satisfication of pelvic muscle training (PISQ-IR) | 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. | up to 2 years |