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Clinical Trial Details (PDF Generation Date :- Tue, 28 Sep 2021 21:47:27 GMT)

CTRI Number CTRI/2019/05/019299 [Registered on: 23/05/2019] - Trial Registered Retrospectively Last Modified On 22/05/2019 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Physiotherapy (Not Including YOGA) Study Design Other Public Title of Study postpartum stress urinary incontinence Scientific Title of The Comparison of 90|90 bridge with ball and balloon exercise with kegel exercise on postpartun Study stress urinary incontinence - randomized clinical trial Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name roma patel Trial Coordinator (multi-center study) Designation 1st year MPT student Affiliation srinivas physiotherapy college Address 3rd floor,gynecology and obstetrics department, wenlock district hospital, hampankatta, , 575001. A-4, first floor, gynecology and obstetrics department,main building,tara hospital, Mangalore. Dakshina 575001 Phone 7383919577 Fax 08242426766 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Rajasheker Query) Designation principal at srinivas physiotherapy college Affiliation srinivas physiotherapy college Address srinivas musculoskeletal OPD, srinivas college of physiotherapy , president A Shama Rao Foundation, GHS road, Mangaluru, karnataka, KARNATAKA 575001 India Phone 9448156719 Fax 08242426766 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name roma patel Designation 1st year MPT student Affiliation srinivas physiotherapy college Address srinivas musculoskeletal OPD, srinivas college of physiotherapy , president A Shama Rao Foundation, GHS road, Mangaluru, karnataka, Dakshina Kannada KARNATAKA

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575001 India Phone 7383919577 Fax 08242426766 Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Srinivas College of Physiotherapy and Research Center, President A Shama Rao Foundation , GHS Road , Mangalore , Karnataka 575001 Primary Sponsor Primary Sponsor Details Name Srinivas College of Physiotherapy and Research Center Address Srinivas College of Physiotherapy and Research Center, President A Shama Rao Foundation , GHS Road , Mangalore , Karnataka 575001 Type of Sponsor Research institution and hospital Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Roma patel Tara hospital A-4, first floor, 7383919577 gynecology and obstetrics romapatel135.rp69@g department,main mail.com building,tara hospital, Mangalore. Dakshina Kannada KARNATAKA Roma aptel wenlock district hospital 3rd floor,gynecology 7383919577 and obstetrics department, wenlock romapatel135.rp69@g district hospital, mail.com hampankatta, mangalore, 575001. Dakshina Kannada KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? srinivas college of Approved 02/06/2018 Yes physiotherapy Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Bladder disorders in diseases classified elsewhere Patients stress urinary incontinence in post par-tum period. Intervention / Type Name Details Comparator Agent Intervention 90/90 bridge with ball and 90/90 bridge with ball and balloon exercise, kegel exercise balloon exercise is help to indirect contraction of pelvic floor muscle with active

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contraction of diaphragm and abdominal muscles. kegel exercise is a pelvic floor strengthening exercise. Comparator Agent Not applicable Not applicable Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 35.00 Year(s) Gender Female Details 1 Pre diagnosed cases of postpartum stress urinary incontinence by gynecologist
2 patient able to sqaut, coughing, running, sit to stand and able to pick object from ground.
3 healthy women- no medical or obstetric complain. Exclusion Criteria Exclusion Criteria Details 1 neurological involvement 2 previous gynecological surgery 3 urinary tract infection 4 concurrent treatment 5 uterine, vaginal, or rectal prolapse

Method of Generating Stratified block randomization Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints modified 20 pad test 2 time . at baseline data and after 4 week intervention. Secondary Outcome Outcome Timepoints kings health questionnaire. 4 time . at baseline data , after 4 week intervention, 6 month follow up and 12 month follow up. Target Sample Size Total Sample Size=60 Sample Size from India=60 Final Enrollment numbers achieved (Total)=60 Final Enrollment numbers achieved (India)=60 Phase of Trial N/A Date of First 01/08/2018 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details non yet

Brief Summary Stress urinary incontinence ( SUI) is common problem during and after pregnancy. postpartum stress urinary incontinence is more seen in younger women. kegel exercise is a type of pelvic floor muscle exercise have been shown effective means to prevent and treat stress urinary incontinence . the new literature has shown that co- ordination of abdominal muscle, diaphragm work and pelvic floor muscle results in a stronger pelvic floor muscle contraction. so 90/90 bridge with ball and balloon exercise is involve all muscle of abdominal, diaphragm, and pelvic floor and try to improve co-ordination of all this muscle. Therefore overall aim of the study is to compare

effect of 90/90 bridge with ball and balloon exercise with kegel exercise on postpartum SUI. Pre-diagnosed postpartum SUI subjects will be screened from gynecology and obstetrics hospital. the whole data collection will divided in group 1 and group 2 by black randomization. the group 1 will be given 90/90 bridge with

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ball and balloon exercise and group 2 will given kegel exercise and also collect the pre-intervention baseline data. this both group will have 4 week intervention period . after that post intervention baseline data will collect with 2 outcome measures

is modified 20 minutes pad test and kings health questionnaire . the follow up of both group will take after and 12 month of intervention.

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