| CTRI Number |
CTRI/2024/08/071887 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
03/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effect of pelvic floor exercises on uroflowmetry parameters in women with stress and mixed urinary incontinence. |
|
Scientific Title of Study
|
Effect of pelvic floor rehabilitation on uroflowmetry parameters in women with stress and mixed urinary incontinence-An experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
vrinda desai |
| Designation |
MPT PG Student |
| Affiliation |
KLE institute of physiotherapy |
| Address |
Department of OBG physiotherapy KAHER institute of physiotherapy Belgaum Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9586745405 |
| Fax |
|
| Email |
vrinda.d2308@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arati Mahishale |
| Designation |
Professor and head of department OBG physio therapy |
| Affiliation |
KLE institute of physiotherapy |
| Address |
Department of OBG physiotherapy KAHER institute of physiotherapy Belgaum Karnataka 590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
9632822622 |
| Fax |
|
| Email |
mphysioarati@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Desai Vrinda Alpeshkumar |
| Designation |
MPT PG student |
| Affiliation |
KLE institute of physiotherapy |
| Address |
Department of OBG physiotherapy KAHER institute of physiotherapy Belgaum Karnataka 590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
09586745405 |
| Fax |
|
| Email |
vrinda.d2308@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Academy of higher education and research institute of physiotherapy Belagavi Karnataka-590010 |
|
|
Primary Sponsor
|
| Name |
vrinda desai |
| Address |
Department of OBG physiotherapy KAHER institute of physiotherapy Belgaum Karnataka 590010
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 |
| Dr vrinda Desai |
KLEs Dr Prabhakar kore hospital and medical research Centre |
Advanced physiotherapy Centre, room no.39sagar floor KLE Dr Prabhakar Kore hospital and MRC Belgaum Karnataka-590010
Belgaum
KARNATAKA |
09586745405
vrinda.d2308@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIPT institutional Research and Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
women with stress and mixed urinary incontinence |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
pelvic floor rehabilitation |
pelvic floor rehabilitation based on uroflowmetry analysis and perfect grading , duration of 1 session will be 30 minutes for 2 times a week for 3 weeks.
Rehabilitation would include- fast twitch contractions ,slow twitch contractions, pelvic clock exercise,pelvic tilts |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
women with stress and mixed incontinence |
|
| ExclusionCriteria |
| Details |
pregnant and lactating women
women undergone pelvic floor surgeries in last 6 months active infection
prevailing cancers neurological condition
grade 3 and 4 POP
medication affecting voiding |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ICIQ QUESTIONNARE AND BFLUTS QUESTIONNARE |
10 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| uroflowmetry analysis |
20 minutes |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
16/09/2024 |
| Date of Study Completion (India) |
06/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="11"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Women of 40-60 years will be asked to fill the ICIQ and BFLUTS questionnaire for severity then will undergo pre and post uroflowmetry analysis pelvic floor rehabilitation would be given |