NCT05618886

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

Recruiting now NA Last updated 9 July 2024

What this trial tests

NA trial testing Education in Urinary Incontinence in 136 participants. Currently enrolling.

Timeline

15 June 2023

Primary endpoint
15 June 2025

31 December 2026

Quick facts

Lead sponsor	Kathmandu University School of Medical Sciences
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	136
Start date	15 June 2023
Primary completion	15 June 2025
Estimated completion	31 December 2026
Sites	2 locations across Nepal

Drugs / interventions tested

• Education
• Education and PFMT

Conditions studied

• Urinary Incontinence — all drugs for Urinary Incontinence →

Sponsor

Kathmandu University School of Medical Sciences

Who can join

Adults 18 to 45, female only, with Urinary Incontinence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women.
   Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, et al · · 2024 · cited 7× · PMID 39704322 · DOI 10.1002/14651858.cd009508.pub2
2. Pelvic Floor Muscle Training for Stress Urinary Incontinence, Fecal Incontinence, and Pelvic Organ Prolapse: A Health Technology Assessment.
   Ontario Health (Quality) . · · 2024 · cited 1× · PMID 39279824