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CTRI Number  CTRI/2022/08/044575 [Registered on: 02/08/2022] Trial Registered Prospectively
Last Modified On: 29/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study To Evaluate The Association Of Respiration And Abdominal Muscle Strength In Women with Urinary Incontinence  
Scientific Title of Study   A Study To Investigate The Correlation Of Respiratory Function And Abdominal Muscle Strength In Women With Urinary Incontinence 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Preeta Mohan Pyati 
Designation  Post Graduate Student 
Affiliation  SDM College Of Physiotherapy 
Address  SDM College Of Physiotherapy Manjushree Nagar Sattur Dharwad Karnataka 580009 India

Dharwad
KARNATAKA
580009
India 
Phone  8884587764  
Fax    
Email  preetapyati14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Preeta Mohan Pyati 
Designation  Post Graduate Student 
Affiliation  SDM College Of Physiotherapy 
Address  SDM College Of Physiotherapy Manjushree Nagar Sattur Dharwad Karnataka 580009 India

Dharwad
KARNATAKA
580009
India 
Phone  8884587764  
Fax    
Email  preetapyati14@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Salima Bijapuri 
Designation  Associate Professor PG Guide 
Affiliation  SDM College Of Physiotherapy 
Address  SDM College Of Physiotherapy Manjushree Nagar Sattur Dharwad Karnataka 580009 India

Dharwad
KARNATAKA
580009
India 
Phone  7760580737  
Fax    
Email  drsalimamulla@gmail.com  
 
Source of Monetary or Material Support  
SDM College Of Physiotherapy 
 
Primary Sponsor  
Name  Preeta Mohan Pyati 
Address  SDM College Of Physiotherapy Manjushree Nagar Sattur Dharwad Karnataka 580009 India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Preeta Mohan Pyati  SDM College Of Medical Sciences And Hospital  Department Of Community Physiotherapy OPD No.13 Manjushree Nagar Sattur Dharwad Karnataka 580009
Dharwad
KARNATAKA 
8884587764

preetapyati14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDM College Of Medical Sciences And Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Urinary Incontinence 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  - Women diagnosed with urinary incontinence
- Women between the age group of 40-60 years
- Able to understand the instructions and follow the
commands
- Consent to participate in the study 
 
ExclusionCriteria 
Details  - Pregnant women
- Women with acute illness
- Obstructive and Restrictive lung diseases
- Recent abdominal surgery within 6 months
- Orthopedic surgery to lower limbs (e.g., amputations, total hip and knee surgeries, fractures) past 6 months
- Neurological disorders
- Terminal disease (e.g., Cancer)
- Inability to answer/understand the question and perform the tests
- Women not willing to participate 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Questionnaire For Female Urinary Incontinence Diagnosis  1 day 
 
Secondary Outcome  
Outcome  TimePoints 
Abdominal Strength Test Board  1 day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/08/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Study not yet started. Waiting for CTRI Registration 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The role of the pelvic floor is essential for the synergy of the diaphragm and abdominal muscles in the maintenance of intra-abdominal pressure. There is mounting evidence that the abdominal, respiratory, and PFM systems all play different roles in expiratory function. It has been hypothesised that diaphragm and abdominal muscle training (DMT and AMT), as well as direct PFM training (PFMT), may have effects on pelvic floor muscle strength (PFMS) and pelvic floor muscle endurance (PFME) that are similar to those of direct PFM training (PFMT), in accordance with physiological functional relationships. If this theory is accurate, the weaknesses of the current data could be addressed, including the ease with which diaphragm and abdominal muscle training can be taught and controlled in terms of intensity, ensuring quality control; measuring muscle strength and endurance, on how various training programmes affect the PFMs, and how this correlates with UI. We propose that expiratory manoeuvres are related to a link between PFM function (as clinically assessed) and expiratory parameters because of the postulated synergistic coactivation of PFM and anterolateral abdominal muscles (as determined by spirometry). 
Therefore, the purpose of this study is to ascertain whether abdominal muscular strength and pulmonary function are related to urinary incontinence in females.
 
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