| CTRI Number |
CTRI/2024/08/072502 [Registered on: 14/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Study to know the Effect of Electromyographic Biofeedback with Home Based Pelvic Floor Exercise Program on Pelvic Floor Muscle Strength and Urinary Incontinence among Postpartum Women |
|
Scientific Title of Study
|
Effect of Electromyographic Biofeedback with Home Based
Pelvic Floor Exercise Program on Pelvic Floor Muscle
Strength and Urinary Incontinence Symptom Among
Postpartum Women |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kokila Kalaivani M |
| Designation |
Post Graduate Student |
| Affiliation |
SRM College Of Physiotherapy SRM Institute Of Science And Technology |
| Address |
Room No:PT33, 5th floor SRM College Of Physiotherapy SRM Medical College Hospital and Research Center SRM Nagar Potheri Kattankulathur Chengalpattu kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9840256319 |
| Fax |
|
| Email |
kokilakalaivanimahesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M Anbupriya |
| Designation |
Associate Professor |
| Affiliation |
SRM College Of Physiotherapy SRM Institute Of Science And Technology |
| Address |
Room No:PT33 5th floor SRM College OF Physiotherapy SRM Medical College Hospital and Research Center SRM Nagar Potheri Kattankulathur Chengalapattu Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9841549219 |
| Fax |
|
| Email |
anbuprim@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
M Anbupriya |
| Designation |
Associate Professor |
| Affiliation |
SRM College Of Physiotherapy SRM Institute Of Science And Technology |
| Address |
Room No:PT33 5th floor SRM College OF Physiotherapy SRM Medical College Hospital and Research Center SRM Nagar Potheri Kattankulathur Chengalapattu Kancheepuram
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9841549219 |
| Fax |
|
| Email |
anbuprim@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital And Research Center, SRM Nagar, Potheri, Kattankulathur, Chengalpattu, Kancheepuram, Tamil Nadu, India - 603203 |
|
|
Primary Sponsor
|
| Name |
Kokila Kalaivani M |
| Address |
Room No:PT33 5th floor SRM College OF Physiotherapy SRM Medical College Hospital and Research Center SRM Nagar Potheri Kattankulathur Chengalapattu Kancheepuram |
| 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 |
| Dr M Anbupriya MPT |
SRM Medical College Hospital and Research Center |
Room No:PT33 5th floor SRM College OF Physiotherapy SRM Medical College Hospital and Research Center SRM Nagar Potheri Kattankulathur Chengalapattu Kancheepuram
Kancheepuram
TAMIL NADU |
9841549219
anbuprim@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER, SRM NAGAR, POTHERI, KATTANKULATHUR, CHENGALPATTU - 603203 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R32||Unspecified urinary incontinence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
electomyographic biofeedback to pelvic floor muscles |
patient education, electrical stimulation to pelvic floor muscles will be given, a session will be 10 - 15 minutes performed 3 times a week for 8 weeks |
| Comparator Agent |
Home based exercise program |
patient education and home based exercise program will be taught using visual representation will be given |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Age 25 years to 35 years
6 weeks after delivery and 3 months postpartum vaginal delivery
Clinically diagnosed SUI or MUI as the primary problem identified using QUID
questionnaire |
|
| ExclusionCriteria |
| Details |
Urgency UI alone
POP Quantification stage more than 2
Third degree and fourth degree perineal tears
Presence of diastasis recti abdominis and chronic pelvic pain as the primary problem
needing treatment
A history of SUI before pregnancy
Previous pelvic surgery
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perineometer Reading EMG Biofeedback |
Pre Test
Post Test (after the duration of 8 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incontinence Severity Index |
Pre Test
Post Test (after the duration of 8 weeks) |
|
|
Target Sample Size
|
Total Sample Size="124"
Sample Size from India="124"
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)
|
24/08/2024 |
| 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="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Individuals will be selected for the study based on inclusion and exclusion criteria. The study will be clearly explained in patients words and an informed consent will be obtained. The subjects will be divided into experimental group(n.64) and control group (n.64). Both the groups will be asked to incontinence severity index questionnaire before and after the study. Experimental group will undergo 8 weeks of electromyographic biofeedback to pelvic floor muscles ( 3 day per week for 10 - 15 minutes), control group will receive home based exercise program to pelvic floor muscles and will be asked to continue. The EMG biofeedback reading will be noted and documented and compared after the completion of 8th week training. Home Based Exercise Program 1. tummy tuck with vaginal squeeze 2. cat and camel with vaginal squeeze 3. butterfly pose with vaginal squeeze 4. wall sit with vaginal squeeze
|