| CTRI Number |
CTRI/2018/01/011488 [Registered on: 23/01/2018] Trial Registered Retrospectively |
| Last Modified On: |
20/01/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Electrical Stimulation In Urinary Incontinence In Women.
|
|
Scientific Title of Study
|
Transcutaneous Posterior Tibial Nerve Stimulation Versus Parasacral Stimulation For Management Of Overactive Bladder In Women:Randomized Controlled Trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shyam Krishnan |
| Designation |
Assistant Professor Senior Scale |
| Affiliation |
KMC Mangalore, Manipal Academy of Heigher Education |
| Address |
Department of Physiotherapy,Bejai KMC Mangalore, Manipal Academy of Heigher Education
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
980072564 |
| Fax |
|
| Email |
krish.shyam@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dolly Das |
| Designation |
Post graduate |
| Affiliation |
KMC Mangalore, Manipal Academy of Heigher Education |
| Address |
Department of Physiotherapy,Bejai KMC Mangalore, Manipal Academy of Heigher Education
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
8328906811 |
| Fax |
|
| Email |
sweetbarbie12may@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dolly Das |
| Designation |
Post graduate |
| Affiliation |
KMC Mangalore, Manipal Academy of Heigher Education |
| Address |
Department of Physiotherapy,Bejai KMC Mangalore, Manipal Academy of Heigher Education
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
8328906811 |
| Fax |
|
| Email |
sweetbarbie12may@gmail.com |
|
|
Source of Monetary or Material Support
|
| KMC ,Manipal Academy of Higher Education,Mangalore Karnataka, 575004 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Manipal Academy of Higher Education, Mangalore Karnataka, 575004 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Shyam Krishnan |
Kasturba Mediacal College |
Dept of Physiotherapy, KMC Mangalore, Manipal Academy of Higher Education
Dakshina Kannada
KARNATAKA |
9880072564
krish.shyam@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College,Mangaluru (Reg. No. ECR/541/Inst/KA/2014) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Overactive Bladder |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Parasacral Stimulation |
Using TENS |
| Intervention |
Posterior Tibial Nerve Stimulation |
Using TENS |
| Comparator Agent |
Sham |
Using TENS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
1)Women 18 years and above having symptoms of OAB.
|
|
| ExclusionCriteria |
| Details |
1)Women with previous history of continence surgery, or history of current bladder malignancy.
2)Pregnant women.
3)Women with any implantable devices.
4)Women with nerve damage that might affect either the Posterior Tibial Nerve or pelvic floor function.
5)Women with current urinary tract infection.
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|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bladder Diary |
Frequency of Urination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
International Consultation on Incontinence Questionnaire
|
Base Line , After 6 Days and at the End of the 12 day. |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
04/02/2017 |
| Date of Study Completion (India) |
15/01/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
AFTER RECRUITMENT TENS WILL BE GIVEN TO SEE ITS EFFECT IN OVERACTIVE BLADDER. FREQUENCY OF URINATION WILL BE SEEN BY THE BLADDER DAIRY ON DAILY BASIS AND ITS EFFECT ON THE QUALITY OF LIFE IN WOMEN WITH OVERACTIVE BLADDER. SITE OF APPLICATION OF TENS WILL BE COMPARED . ITS A PILOT STUDY .DATA ANALYSIS STILL TO BE DONE. |