| CTRI Number |
CTRI/2017/08/009276 [Registered on: 04/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
06/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Pelvic Floor Muscle Exercise and Bladder Re-training Program on Urinary Incontinence |
|
Scientific Title of Study
|
Effectiveness of Pelvic Floor Muscle Exercise and Bladder Re-training Program on Symptoms and Quality of Life of Women with stress, urge and mixed Urinary Incontinence in Selected Tertiary Care Hospital at Mangalore |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suchithra BS |
| Designation |
Asst. Professor |
| Affiliation |
Nitte University |
| Address |
Nitte Usha Institute of Nursing Sciences,Nitte University, Paneer, Deralakatte, Kotekar beeri Road . Mangalore
K. S . Hegde charitable hospital ,
Deralakatte
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9980185750 |
| Fax |
0824-2203163 |
| Email |
suchithra@nitte.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Fatima D Silva |
| Designation |
Principal |
| Affiliation |
Nitte University |
| Address |
Nitte Usha Institute of Nursing Sciences,Nitte University, Paneer, Deralakatte, Kotekar beeri Road . Mangalore
KS Hegde Charitable hospital , Deralakatte
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9945064006 |
| Fax |
0824-2203163 |
| Email |
ftds_1970@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeev TP |
| Designation |
Hod dept. of Urology and Professor |
| Affiliation |
Nitte University |
| Address |
KS Hegde Charitable hospital
Deralakatte
Mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9986451908 |
| Fax |
|
| Email |
rajeevtp@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Justice K S Hegde Charitable hospital, Deralakatte, Mangalore . 575018
Deralakatte |
|
|
Primary Sponsor
|
| Name |
Suchithra BS |
| Address |
justice K S Headge Charitable hospital
Deralakatte
Mangalore
575018
|
| Type of Sponsor |
Other [self funded ] |
|
|
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 |
| Suchithra BS |
KSHEMA |
Dept. of Urology , K S Hegde Charitable hospital Deralakatte , Mangalore.575018
Dakshina Kannada
KARNATAKA |
9980185750
0824-2203163
suchithra@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee,Nitte University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patient with stress, Urge, or Mixed Urinary Incontinence , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Pelvic Floor Exercise , Bladder Retraining Programme , combined method. |
In Pelvic Floor Muscle Exercise the women will be taught exercises involving controlled contraction and release of the muscles at the base of the pelvis where the subject should hold the contraction for 10 seconds followed by 10 seconds of relaxation which should be performed 10 times for 3-5 times a day for 3 months.
In Bladder retraining program the schedule which is prepared by the investigator will be given to the subject and subject will be asked to follow as per the guideline.
In combined method both PFE and Bladder training programme will be taught. Bladder retraining program the schedule which is prepared by the investigator will be given to the subject and subject will be asked to follow as per the guideline and Pelvic Floor Muscle Exercise will be taught exercises involving controlled contraction and release of the muscles at the base of the pelvis where the subject should hold the contraction for 10 seconds followed by 10 seconds of relaxation which should be performed 10 times for 3-5 times a day for 3 months |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. Women diagnosed with urinary incontinence
2. Women who are likely to come for follow up.
2. Women who are able to practice the intervention as per the guideline.
|
|
| ExclusionCriteria |
| Details |
1. Women undergone surgical intervention for urinary incontinence
2. Women above 60 years of age
3. Women not attending follow up clinic
4. Women those who are suffering with severe medical illness and on treatment
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
There will be significant reduction in symptoms of Urinary incontinence among women after implementing Pelvic Floor Muscle Exercise and Bladder training program.
There will be significant difference in the Quality of life before and after the Pelvic Floor Muscle Exercise.
There will be significant difference in the Quality of life before and after Bladder retraining program. |
2 yrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The combined effect of Bladder retraining program and Pelvic Floor Muscle Exercise will be significantly greater than the individual intervention
There will be a significant association of Urinary incontinence with selected variables |
2 yrs |
|
|
Target Sample Size
|
Total Sample Size="196"
Sample Size from India="196"
Final Enrollment numbers achieved (Total)= "159"
Final Enrollment numbers achieved (India)="159" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
31/05/2017 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of this study is to identify the factors associated with Urinary incontinence, to find the effectiveness of pelvic floor exercise, bladder training programme to the patient with stress, urge and mixed urinary incontinence. This study also helps to know the quality of life of patient with Urinary Incontinence |