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

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.

Study Overview

• Status: Recruiting
• Conditions: Urinary Incontinence
• Intervention / Treatment: Other: Education; Other: Education and PFMT

Detailed Description

Urinary Incontinence (UI) is a widespread condition among women of all ages. UI is defined as involuntary urine leakage and categorized into three subcategories; the most common type Stress UI (SUI) concerns urine leakage associated with physical exertion, coughing and sneezing; Urge UI (UUI) involves a sudden urge to pass urine which is preceded or accompanied by urine leakage while mixed UI involves both SUI and UUI. UI has a negative impact on quality of life. It can cause social problems by creating embarrassment and negative self-perception, can reduce social interaction and physical activities, and also affect sexual relationship leading to anxiety and depression.

Population studies from numerous countries have reported that the prevalence of UI ranges from approximately 5%-70%, with most studies reporting a prevalence of UI to be between 25-45%. Few studies have examined UI in Nepal. One study among women with gynecological disorders in eastern Nepal reported a prevalence of UI to be as high as 50%. A large community based survey among 14,469 women in rural Nepal, found the prevalence of SUI and UUI to be 24% and 14%, respectively.

The large variation of prevalence between studies could be because of methodological differences, such as different data collection procedures with use of different questionnaires. The International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is however the recommended subjective measure of severity of urinary loss and quality of life for those with UI. The questionnaire has been used in many studies for the assessment of UI and is available in different languages with good reliability and validity. So far, there is a lack of a Nepali version of the ICIQ-UI SF. Hence, it is a need to translate and cross-culturally adapt the ICIQ-UI SF into Nepali.

A recent Cochrane review showed that pelvic floor muscle training (PFMT) is effective for women with SUI, UUI, or mixed UI and is recommended as a first line conservative treatment over at least 3 months duration. The efficacy of PFMT is well established in national and international guidelines but to our knowledge no previous studies have assessed the effectiveness of PFMT for UI among Nepalese women.

• Study Type: Interventional
• Enrollment (Estimated): 136
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bimika Khadgi, MPT; Phone Number: +9779849264211; Email: bimikakhadgi@kusms.edu.np
• Study Contact Backup: Name: Ann-Katrin Stensdotter

Study Locations

• Nepal
  • Kathmandu, Nepal, 44600
    • Not yet recruiting
    • Bimika Khadgi
    • Contact: Bimika khadgi; Phone Number: +9779849264211; Email: bimikakhadgi@kusms.edu.np
    • Principal Investigator: Ranjeeta Acharya, PhD
    • Sub-Investigator: Ann-Katrin Stensdotter, PhD
    • Sub-Investigator: Britt Stuge, PhD
    • Sub-Investigator: Corolia Brandt, PhD
  • Kavrepalanchok District- 3
    • Dhulikhel, Kavrepalanchok District- 3, Nepal, 45210
      • Recruiting
      • Dhulikhel Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Between age of 18-45 years
• ICIQ grading above 3
• Understand Nepali language
• Willing to be included in the study
• Phone availability

Exclusion Criteria:

• Pregnant
• Planning for pregnancy within a 6 months period
• Waiting for gynaecological surgery
• History of bladder, renal, or uterine cancer
• Menopause
• Stage IV pelvic organ prolapse
• Cognitive or mental disorders
• Illness to mother or family members, not making exercising possible

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; Education given to all participants included before randomization. Information about UI, PFM and PFMT, together with lifestyle advices such as using the 'knack' (pre-contracting the PFM before coughing and sneezing), maintaining healthy weight, toilet habits, and reducing constipation and intra-abdominal pressure. The education session will last 30 minutes, and include a video (https://www.youtube.com/watch?v=XsDpfq10JMI) and a leaflet containing the information given.	Other: Education; The education about urinary incontinence, PFM and PFMT together with lifestyle behavior modifications such as using the knack, maintaining healthy weight, toilet habits, and reducing constipation and intra-abdominal pressure will be provided along with the PFMT instruction.
Experimental: intervention group; Along with education session, twelve weekly face-to-face sessions of PFMT with exercises individually or in groups with the women's health physiotherapist will be offered. PFMT will be taught on the basis of observation, vaginal palpation and camtech manometry, and will be individualized initially to suit each participant's ability within a protocol encouraging 10 close-to-maximum contractions and 6-8-second hold with a 10-second rest between contractions. During the first two appointments, participant will be instructed to perform two sessions with rest in between and thereafter three times 10 contractions if possible during each visit. The participants will be encouraged to perform daily PFMT (10 contraction x 3 10times, 3 sets) at home and will be asked to record their PFMT in an exercise diary	Other: Education and PFMT; Along with education twelve weekly face-to-face sessions of PFMT with exercises individually or in groups with the women's health physiotherapist will be offered. PFMT will be taught on the basis of observation, vaginal palpation and camtech manometry, and will be individualized initially to suit each participant's ability within a protocol encouraging 10 close-to-maximum contractions and 6-8-second hold with a 10-second rest between contractions. During the first two appointments, participant's will be instructed to perform two sessions with rest in between and thereafter three times 10 contractions if possible during each visit. The participant's will be encouraged to perform daily PFMT (10 contraction x 3 10times, 3 sets) at home and will be asked to record their PFMT in an exercise diary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) will be used as primary outcome tool as it is recommended as self-reported patient outcome measure for UI.	The ICIQ-UI SF consists of four items which evaluate the frequency, amount of leakage, overall impact of UI and self-diagnostic item. The overall score ranges from 0 to 21, with greater values indicating increased severity. The difference in change from baseline of ICIQ-UI SF scores of patients after intervention will report the effect of the intervention.	Baseline, 12 week , 6month,12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-Efficacy Scale for Practicing Pelvic Floor muscle Exercise (SESPPFE) will be used to measure the self efficacy of PFMT as it is a valid and reliable outcome tool .	SESPPFE is 17 items tool to measure self-efficacy of practicing PFM exercises with two components: self-efficacy score of 13 and outcome expectation score of 4. The interpretation will be done as higher scores means better self-efficacy or outcome expectation. The scores higher than 70% will be interpreted as relatively good self-efficacy.	Baseline, 12 weeks, 6 months, 12 months
The presence of contraction will be determined through the Rating Scale of contraction and also with A manometer from Camtech AS (Norway)	To ensure valid measurements, only PFM contractions with simultaneous visible inward movement of the perineum and a manometer will be used. Through the manometer resting tone will be calculated as the difference between atmospheric pressure and the mean vaginal pressure at rest before and between the PFM contractions (cmH2O). Maximum volumetric contraction (MVC) will be calculated as a mean of three MVCs (cmH2O). PFM endurance will be recorded as a sustained maximal contraction for 10 seconds, quantified as the area under the curve (cmH2Osec)	Baseline,12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline and knowledge questionnaire	The baseline questionnaire will be containing socio-demographic variables and questions related to knowledge of UI PFM and experience with PFMT will also be recorded.	baseline, 12months

Collaborators and Investigators

• Sponsor: Kathmandu University School of Medical Sciences
• Collaborators: Norwegian University of Science and Technology
• Investigators: Principal Investigator: Ranjeeta Acharya, PhD, KUSMS; Study Director: Britt Stuge, PhD, Oslo; Study Director: Corlia Brandt, WITS

Publications and helpful links

General Publications

• Shijagurumayum Acharya R, Tveter AT, Grotle M, Khadgi B, Braekken IH, Stuge B. Pelvic floor muscle training programme in pregnant Nepalese women-a feasibility study. Int Urogynecol J. 2020 Aug;31(8):1609-1619. doi: 10.1007/s00192-019-04053-1. Epub 2019 Jul 25.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 31, 2022
• First Submitted That Met QC Criteria: November 9, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 7, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Nepali women, PFMT, intervention study
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Incontinence; Enuresis
• Other Study ID Numbers: KUSMS PT (WH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No