[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486808":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":42,"locations":50,"responsibleParty":85,"collaborators":88,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":25,"eligibilityCriteria":96,"healthyVolunteers":93,"sex":97,"minAge":98,"maxAge":99,"enrollmentInfo":100,"targetDuration":25,"studyType":103,"phases":104,"briefSummary":106,"conditions":107,"keywords":109,"overallStatus":53,"whyStopped":25,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Kathmandu University School of Medical Sciences","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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:\u002F\u002Fwww.youtube.com\u002Fwatch?v=XsDpfq10JMI) and a leaflet containing the information given.",[13],"Other: Education",{"label":15,"type":16,"description":17,"interventionNames":18},"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",[19],"Other: Education and PFMT",[21,26],{"type":6,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"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.",[9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"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.",[15],[31,35,39],{"name":32,"affiliation":33,"role":34},"Ranjeeta Acharya, PhD","KUSMS","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":38},"Britt Stuge, PhD","Oslo","STUDY_DIRECTOR",{"name":40,"affiliation":41,"role":38},"Corlia Brandt","WITS",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":25,"email":47},"Bimika Khadgi, MPT","CONTACT","+9779849264211","bimikakhadgi@kusms.edu.np",{"name":49,"role":45,"phone":25,"phoneExt":25,"email":25},"Ann-Katrin Stensdotter",[51,65],{"facility":52,"status":53,"city":54,"state":55,"zip":56,"country":57,"countryCode":58,"cosmosGeoPoint":59,"geoPoint":64,"contacts":25},"Dhulikhel Hospital","RECRUITING","Dhulikhel","Kavrepalanchok District- 3","45210","Nepal","NP",{"type":60,"coordinates":61},"Point",[62,63],85.54281,27.6221,{"lat":63,"lon":62},{"facility":66,"status":67,"city":68,"state":25,"zip":69,"country":57,"countryCode":58,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Bimika Khadgi","NOT_YET_RECRUITING","Kathmandu","44600",{"type":60,"coordinates":71},[72,73],85.3206,27.70169,{"lat":73,"lon":72},[76,78,79,82,83],{"name":77,"role":45,"phone":46,"phoneExt":25,"email":47},"Bimika khadgi",{"name":32,"role":34,"phone":25,"phoneExt":25,"email":25},{"name":80,"role":81,"phone":25,"phoneExt":25,"email":25},"Ann-Katrin Stensdotter, PhD","SUB_INVESTIGATOR",{"name":36,"role":81,"phone":25,"phoneExt":25,"email":25},{"name":84,"role":81,"phone":25,"phoneExt":25,"email":25},"Corolia Brandt, PhD",{"type":34,"investigatorFullName":86,"investigatorTitle":87,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Bimika Khadgi, PT","Associate Professor, PhD candidate",[89],{"name":90,"class":6},"Norwegian University of Science and Technology","100486808","the-effect-of-pelvic-floor-muscle-training-for-urinary-incontinence-in-nepalese-women-100486808",false,"NCT05618886","The Effect of Pelvic Floor Muscle Training for Urinary Incontinence in Nepalese Women","Inclusion Criteria:\n\n* Between age of 18-45 years\n* ICIQ grading above 3\n* Understand Nepali language\n* Willing to be included in the study\n* Phone availability\n\nExclusion Criteria:\n\n* Pregnant\n* Planning for pregnancy within a 6 months period\n* Waiting for gynaecological surgery\n* History of bladder, renal, or uterine cancer\n* Menopause\n* Stage IV pelvic organ prolapse\n* Cognitive or mental disorders\n* Illness to mother or family members, not making exercising possible","FEMALE","18 Years","45 Years",{"count":101,"type":102},136,"ESTIMATED","INTERVENTIONAL",[105],"NA","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.",[108],"Urinary Incontinence",[110],"Nepali women, PFMT, intervention study","2024-07-07",{"date":113,"type":114},"2024-07-09","ACTUAL",{"date":116,"type":114},"2023-06-15",{"date":118,"type":102},"2026-12-31",{"name":5,"class":6},2]