Urinary IncontinenceNCT05618886
The Effect of Pelvic Floor Muscle Training for Urinary Incontinence in Nepalese Women
A study testing Education and Education and PFMT in people with Urinary Incontinence, run by Kathmandu University School of Medical Sciences at 2 sites in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- Education and Education and PFMT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesNepal
- Study dates
- 15 Jun 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Between age of 18-45 years
- ICIQ grading above 3
- Understand Nepali language
- Willing to be included in the study
- Phone availability
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ann-Katrin Stensdotter contact
Nepal2 sites, 2 recruiting
- Recruiting
Dhulikhel Hospital
Dhulikhel, Kavrepalanchok District- 3, 45210
- Not yet recruiting
Bimika Khadgi
Kathmandu, 44600
Bimika khadgi, +9779849264211, bimikakhadgi@kusms.edu.np
Ranjeeta Acharya, PhD
About this study
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.
Read the 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
- Being tested
- Education, Education and PFMT
- Keywords
- Nepali women, PFMT, intervention study
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationOther
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.
Education and PFMTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Education and PFMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
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.
Measured: 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)
Measured: Baseline,12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2022
- Study start15 Jun 2023
- Primary completion15 Jun 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kathmandu University School of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Principal investigator, Bimika Khadgi, PT, Kathmandu University School of Medical Sciences
- Investigators
- Ranjeeta Acharya, PhD, Principal investigator, KUSMSBritt Stuge, PhD, Study director, OsloCorlia Brandt, Study director, WITS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05618886
- Sponsor's protocol ID
- KUSMS PT (WH)
- Status last verified
- Jul 2024
- First submitted
- 31 Oct 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31346671Hay-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.
PubMed 39704322
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pelvic Floor Muscle Training for Urinary Incontinence in Nepalese Women
- ClinicalTrials.gov ID
- NCT05618886
- Acronym / sponsor ID
- KUSMS PT (WH)
- Conditions
- Urinary Incontinence
- Keywords
- Nepali women, PFMT, intervention study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Kathmandu University School of Medical SciencesUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: EducationEducation 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. |
| intervention group | Experimental | Other: Education and PFMTAlong 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between age of 18-45 years
- ICIQ grading above 3
- Understand Nepali language
- Willing to be included in the study
- Phone availability
Key exclusion criteria (8 listed)
- Pregnant
- Planning for pregnancy within a 6 months period
- Waiting for gynaecological surgery
- History of bladder, renal, or uterine cancer
- Menopause
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationThe 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. | Other | control group |
| Education and PFMTAlong 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. | Other | intervention group |
Primary outcome
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.
Time frame: Baseline, 12 week , 6month,12 month
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.
2 secondary outcomes
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 .
Time frame: 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)
Time frame: Baseline,12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Results publication: PubMed 31346671Shijagurumayum 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.
- Derived from this study: PubMed 39704322Hay-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ann-Katrin Stensdotter contact
Ranjeeta Acharya, PhD principal investigator
KUSMS
Britt Stuge, PhD study director
Oslo
Corlia Brandt study director
WITS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Education and PFMT in people with Urinary Incontinence, run by Kathmandu University School of Medical Sciences at 2 sites in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bimika Khadgi, MPT (+9779849264211, bimikakhadgi@kusms.edu.np), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Baseline, 12 week , 6month,12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05618886, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.