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

NCT ID: NCT05618886

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-15
• Study Completion Date: 2026-12-31

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.

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.

Conditions

Urinary Incontinence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Education

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

Education and PFMT

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

Kathmandu University School of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Bimika Khadgi, PT

Associate Professor, PhD candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ranjeeta Acharya, PhD

Role: PRINCIPAL_INVESTIGATOR

KUSMS

Britt Stuge, PhD

Role: STUDY_DIRECTOR

Oslo

Corlia Brandt

Role: STUDY_DIRECTOR

WITS

Locations

Dhulikhel Hospital

Dhulikhel, Kavrepalanchok District- 3, Nepal

Site Status: RECRUITING

Bimika Khadgi

Kathmandu, , Nepal

Site Status: NOT_YET_RECRUITING

Countries

Nepal

Central Contacts

Bimika Khadgi, MPT

Role: CONTACT

bimikakhadgi@kusms.edu.np

+9779849264211

Ann-Katrin Stensdotter

Role: CONTACT

Facility Contacts

Bimika khadgi

Role: primary

bimikakhadgi@kusms.edu.np

+9779849264211

References

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.

Reference Type: RESULT

PMID: 31346671 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 39704322 (View on PubMed)

Other Identifiers

KUSMS PT (WH)

Identifier Type: -

Identifier Source: org_study_id