| CTRI Number |
CTRI/2024/11/077161 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Impact Of Postpartum Physical Therapy Protocol On Urinary Incontinence In Women After Vaginal Birth Cases |
|
Scientific Title of Study
|
Effect of Postpartum Physical Therapy Protocol For Urinary Incontinence in Post Vaginal Birth Cases |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Megha Yadav |
| Designation |
Professor |
| Affiliation |
Galgotias University |
| Address |
Dr. Megha Yadav
Plot no.2 Sector 17A Yamuna Expressway Greater Noida Gautam Buddh Nagar
NA
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
09711147463 |
| Fax |
|
| Email |
meghayadav1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ayesha Siddique |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Plot no.2 Sector 17A Yamuna Expressway Greater Noida Gautam Buddh Nagar
NA
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9031873069 |
| Fax |
|
| Email |
dr.ayeshanaaz1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ayesha Siddique |
| Designation |
Student |
| Affiliation |
Galgotias University |
| Address |
Plot no.2 Sector 17A Yamuna Expressway Greater Noida Gautam Buddh Nagar Uttar Pradesh
Plot no.2 Sector 17A Yamuna Expressway Greater Noida Gautam Buddh Nagar Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
203201
India |
| Phone |
9031873069 |
| Fax |
|
| Email |
dr.ayeshanaaz1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Research and Developmental cell, Galgotias University, Plot no.2 Sector 17A Yamuna Expressway Greater Noida Gautam Buddh Nagar, Uttar Pradesh, Pincode-203201 |
|
|
Primary Sponsor
|
| Name |
GALGOTIAS UNIVERSITY |
| Address |
Plot no.2 Sector 17A Yamuna Expressway Greater Noida Gautam Buddh Nagar Uttar Pradesh India 203201 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Megha Yadav |
Galgotias University |
Plot No. 2, Yamuna Expy, opposite Buddha International Circuit, Sector 17A, Greater Noida, Uttar Pradesh 203201
Gautam Buddha Nagar
UTTAR PRADESH |
9711147463
meghayadav1987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Departmental Research Committee, Galgotias University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O758||Other specified complications of labor and delivery, (2) ICD-10 Condition: O100||Pre-existing essential hypertension complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Aerobic Exercises |
4 times a weeks for a period of 6 weeks. |
| Intervention |
Physical therapy |
4 times a weeks for a period of 6 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
1.Females with history of post vaginal delivery.
2.Occasional urinary incontinence, heaviness and pressure
3.Varying level of pain in their current Pregnancies. |
|
| ExclusionCriteria |
| Details |
Grade 4 Perineal tear during delivery
Females who had high risk Pregnancies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Episodes of Urine leak |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not Applicable |
Not Applicable |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/12/2024 |
| 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="3"
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
|
Urinary Incontinence is often known as involuntary urine leakage is a stresssful and socially restrictive disorder that affects approximately one in every three women .Many women who experinence urinary incontinence may not report their symptoms due to social embarrassment. urinary incontinence is dived into 3 types . 1. Stress urinary incontinence :- The most prevalent kind is concered with urine leakage related with physical activity,coughing and sneezing. 2. Uregency urinary incontinence:- It is defined as the sudden desire to pass .that is preceeded or accompained by incontinece and includes both stress and urgency urinary incontinence 3.Mixed urinary incontinence;- Stress and mixed urinary incontinence are currently treated with 3 months of regular and progressive pelvic floor muscle training ( PFMT).
Methdology:- .This study will include random allocation of participants in two groups. Group1;- Physical therapy group . This group will receive exercise session 4 times a week for aperiod of 6 weeeks. Group2:- Aerobic activity. Thia group will be doing any aerobic activity 4 times aweek for a period of 6 week.
|