Clinical trial NCT05618886: The Effect of Pelvic Floor Muscle Training for Urinary Incontinence in Nepalese Women
Official title: The Effect of Pelvic Floor Muscle Training for Urinary Incontinence in Nepalese Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Incontinence
Keywords: Nepali women, PFMT, intervention study
Lead sponsor: Kathmandu University School of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2022-11-16
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: Baseline, 12 week , 6month,12 month
Secondary outcomes:
measure: 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 .
timeFrame: Baseline, 12 weeks, 6 months, 12 months
measure: The presence of contraction will be determined through the Rating Scale of contraction and also with A manometer from Camtech AS (Norway)
timeFrame: Baseline,12 weeks
Other outcomes:
measure: Baseline and knowledge questionnaire
timeFrame: baseline, 12months
Locations:
city: Dhulikhel
country: Nepal
facility: Dhulikhel Hospital
state: Kavrepalanchok District- 3
city: Kathmandu
country: Nepal
facility: Bimika Khadgi
Study officials:
affiliation: KUSMS
name: Ranjeeta Acharya, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo
name: Britt Stuge, PhD
role: STUDY_DIRECTOR
affiliation: WITS
name: Corlia Brandt
role: STUDY_DIRECTOR
References:
citation: 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.