| CTRI Number |
CTRI/2019/08/020782 [Registered on: 20/08/2019] Trial Registered Prospectively |
| Last Modified On: |
02/03/2020 |
| 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 control trial to study the effect of Pelvic Floor exercises along with Transverse Abdominis exercise for girls with incontinence while laughing. |
|
Scientific Title of Study
|
Effectiveness of co- contraction of Transverse Abdominis and Pelvic Floor Muscle for Giggle Incontinence in school going girls -A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nadha Muhammad Sajid |
| Designation |
MPT student |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy, Derlakatte, Mangaluru
Department of Physiotherapy, Justice K.S Hegde Charitable Hospital, Derlakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9895082322 |
| Fax |
|
| Email |
nadhabpt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Suchetha P S |
| Designation |
Associate Professor |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy, Derlakatte, Mangaluru
Department of Physiotherapy, Justice K.S Hegde Charitable Hospital, Derlakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448441292 |
| Fax |
|
| Email |
suchetaps.bhat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nadha Muhammad Sajid |
| Designation |
MPT student |
| Affiliation |
Nitte Institute of Physiotherapy |
| Address |
Nitte Institute of Physiotherapy, Derlakatte, Mangaluru
Department of Physiotherapy, Justice K.S Hegde Charitable Hospital, Derlakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9895082322 |
| Fax |
|
| Email |
nadhabpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nadha Muhammad Sajid
Nitte Institute of Physiotherapy, Deralakatte, Mangaluru |
|
|
Primary Sponsor
|
| Name |
Nadha Muhammad Sajid |
| Address |
Nitte Institute of Physiotherapy, Derlakatte, Mangaluru |
| 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 |
| Nadha |
Kuthar Government School |
Thokottu, Mangaluru
Dakshina Kannada
KARNATAKA |
9895082322
nadhabpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N394||Other specified urinary incontinence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Co-contraction of Pelvic Floor Muscle and Transverse Abdominis Muscle |
Co-contraction of Pelvic Floor Muscle and Transverse Abdominis Muscle |
| Comparator Agent |
Knack Principle |
The participants in control group are asked to contract the Pelvic Floor Muscles when giggling. |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Female |
| Details |
Girls with incontinence while laughing or giggling
Urinary leakage while laughing at least twice monthly.
Girls who are willing to participate
|
|
| ExclusionCriteria |
| Details |
Incontinence due to any cause other than GI.
Undergoing treatment for incontinence
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The Dysfunctional Voiding and Incontinence Symptoms Score Questionnaire |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pediatric urinary incontinence QOL tool. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2019 |
| Date of Study Completion (India) |
27/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized control trial to study the effect of co- contraction of transverse abdominis and pelvic floor muscles in school going girls between the age of 8 to 15 years. . For group A one session of exercise 3 times per week is to be performed by the subjects. The subjects were also taught ‘Knack’ principle as a preventive measure. Group B the subjects were taught ‘Knack’ principle. No regular treatment was done for this group. |