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NCT Number: NCT05778552

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

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.

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Key information

Conditions

Pelvic Floor Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Pregnancy Complications Prolapse Signs and Symptoms Stress Urinary Incontinence Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Performed home-based pelvic muscle training devices at home or traditional PFMT at hospital

Primary outcomes

  1. The satisfication of pelvic muscle training (UDI-6)

    Time frame: 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.

  2. The satisfication of pelvic muscle training (ICIQ-SF)

    Time frame: 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.

  3. The satisfication of pelvic muscle training (IIQ-7)

    Time frame: 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.

  4. The satisfication of pelvic muscle training (POPDI-6)

    Time frame: up to 2 years

    POPDI-6 scores range from 0 to 24 and higher scores indicate worse bulging symptoms

  5. The satisfication of pelvic muscle training (PISQ-IR)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Huann-Cheng Horng

CONTACT

[email protected]

886-(2) 2875-7826

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 21, 2023
Registry last updated
Mar 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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