| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Urinary Incontinence |
|
|
Intervention / Comparator Agent
|
|
|
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. |