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The Effect of Pelvic Floor Muscle Training for Urinary Incontinence in Nepalese Women

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated July 9, 2024 (before its estimated June 15, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Jun 15, 2024 to Jun 15, 2025v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Start date changed from estimate of May 15, 2023 to Jun 15, 2023
    v4
  3. Start date: Jan 15, 2023 to May 15, 2023v3
  4. Primary endpoint revised
    • Secondary endpoints revised (2)
    • Study description shortened, about 2 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of the study is to find the effectiveness of Pelvic floor muscle training (PFMT) for urinary incontinence (UI) among Nepalese women. After screening the women who meet the inclusion criteria will be included. Verbal and written consent will be taken from individual participants then the baseline questionnaire data containing socio-demographic variables and questions related to knowledge of UI, PFM and experience with PFMT and ICIQ UI SF will be collected. Then, a women's health physiotherapist will provide education about UI, PFM, PFMT and lifestyle advice. After the education session the randomisation of the participants into either education only (group A) or education plus PFMT (group B) 1:1 by concealed allocation (sealed envelope with A and B). After allocation, the participants will stay in their assigned intervention group for 1 year. After 12 weeks of the supervised intervention again ICIQ UI SF will be administered by a research assistant to both groups. In the 6th month again ICIQ UI SF will be administered by a research assistant to both groups. Finally, in the 12th month again ICIQ UI SF along with self-efficacy and knowledge questions will be assessed to find the effectiveness of the intervention. This data will help in the further development of the protocol or guideline for the Nepalese women.
Trial Details
NCT Number NCT05618886
Lead Sponsor Kathmandu University School of Medical Sciences
Collaborators: Norwegian University of Science and Technology
Conditions
(from sponsor)		 Urinary Incontinence
Related terms Urinary Incontinence
Enrollment 136 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov