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.
Between age of 18-45 years
ICIQ grading above 3
Understand Nepali language
Willing to be included in the study
Pregnant
Planning for pregnancy within a 6 months period
Waiting for gynaecological surgery
History of bladder, renal, or uterine cancer
Parallel
Education
Other interventionThe 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.
Education and PFMT
Other interventionAlong 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.
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.
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.
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 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.
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Kathmandu University School of Medical Sciences
Lead sponsor
Norwegian University of Science and Technology
Collaborator
