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

NCT05618886 | Recruiting DMC

• 1 other identifier: KUSMS PT (WH)
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Urinary Incontinence

Keywords

Nepali women, PFMT, intervention study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 .

  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)

  Baseline,12 weeks

Other Outcomes (1)

• Baseline and knowledge questionnaire

  baseline, 12months

Study Arms (2)

control group

ACTIVE COMPARATOR

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

intervention group

EXPERIMENTAL

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

Interventions

Education OTHER

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.

control group

Education and PFMT OTHER

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.

intervention group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: women with UI
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kathmandu University School of Medical Sciences: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (2)

Dhulikhel Hospital

Dhulikhel, Kavrepalanchok District- 3, 45210, Nepal

RECRUITING

Bimika Khadgi

Kathmandu, 44600, Nepal

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 31346671 RESULT

• Hay-Smith EJC, Starzec-Proserpio M, Moller B, Aldabe D, Cacciari L, Pitangui ACR, Vesentini G, Woodley SJ, Dumoulin C, Frawley HC, Jorge CH, Morin M, Wallace SA, Weatherall M. Comparisons of approaches to pelvic floor muscle training for urinary incontinence in women. Cochrane Database Syst Rev. 2024 Dec 20;12(12):CD009508. doi: 10.1002/14651858.CD009508.pub2.

  PMID: 39704322 DERIVED

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Ranjeeta Acharya, PhD

  KUSMS

  PRINCIPAL INVESTIGATOR

• Britt Stuge, PhD

  Oslo

  STUDY DIRECTOR

• Corlia Brandt

  WITS

  STUDY DIRECTOR

Central Study Contacts

Bimika Khadgi, MPT

CONTACT

+9779849264211; bimikakhadgi@kusms.edu.np

Ann-Katrin Stensdotter

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A research assistant(assessor) will use a Samsung tablet with open data kit software to collect and record baseline questionnaire data containing socio-demographic variables and questions related to knowledge of UI (describe UI, the causes and treatment options and how participant's learnt about it), PFM and experience with PFMT of all the subjects. Assessor will not have any idea about the participant's in the treatment group and the control group. Assessor will be assessing through the patient reported questionnaire tool.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, PhD candidate

Model Details: The participants will be randomize 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

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 16, 2022
• Study Start: June 15, 2023
• Primary Completion: June 15, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NE (2)