| CTRI Number |
CTRI/2024/09/073662 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
27/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Participants with complaint of involuntary leakage of urine perform Kegel exercises with pressure probe |
|
Scientific Title of Study
|
Design and Development of Sensor Based Pressure Probe and Establishing its Efficacy in the Dosimetry of Kegel Exercises among Females with Urinary Incontinence |
| 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 Arushi Mishra |
| Designation |
Assistant Professor |
| Affiliation |
Department of Physiotherapy |
| Address |
Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan
Room Number 510 2nd Floor Maharishi Markandeshwar Medical College and Hospital
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8219368147 |
| Fax |
|
| Email |
arushimishra799@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amandeep Singh |
| Designation |
Professor |
| Affiliation |
Department of Physiotherapy |
| Address |
Chitkara School of Health Science Room number 102 Chitkara University Rajpura Punjab
Chitkara School of Health Science Room number 102 Chitkara University Rajpura Punjab
Patiala
PUNJAB
140401
India |
| Phone |
9780023845 |
| Fax |
|
| Email |
s.amandeep@chitkara.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arushi Mishra |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar Medical College and Hospital |
| Address |
Physiotherapy Outpatient department Room number 510 2nd Floor Maharishi Markandeshwar Medical College and Hospital
Department of Physiotherapy Room Number 510 2nd Floor
Solan
HIMACHAL PRADESH
173229
India |
| Phone |
8219368147 |
| Fax |
|
| Email |
arushimishra799@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan Himachal Pradesh Picofe 173229 |
|
|
Primary Sponsor
|
| Name |
Maharishi Markandeshwar University |
| Address |
Kumarhatti Solan Himachal Pradesh |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Amandeep Singh |
Chitkara University Rajpura Punjab |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arushi Mishra |
Maharishi Markandeshwar Medical college and Hospital |
Department of Physiotherapy
2nd floor
Room Number 510
Solan
HIMACHAL PRADESH |
8219368147
arushimishra799@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maharishi Markandeshwar Medical College and Hospital 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 |
Group1a |
A total of 29 Participants will perform Kegel exercise in supine crook lying position The pressure sensor probe will be inserted into vagina allowing the transmission of pressure reading of pelvic floor muscle along with duration of contraction Participants will be instructed to execute three sets of eight maximal contraction withhold time of the squeeze 6 to 8 seconds and rest interval of 6 seconds in between twice daily for a total duration of 3 months |
| Intervention |
Group1b |
A total of 29 participants will perform the Kegel exercise with sensor pressure probe withhold time of 5 seconds followed by rest interval of 15 seconds of 3 sets of 15 voluntary contraction two times a day for 3 months |
| Intervention |
Group1c |
A total of 29 participants will perform Kegel exercise with sensor pressure probe Participants will be instructed to perform 25 maximum contraction of 3 sets of Kegel exercise with 3 seconds of squeeze and 3 seconds of rest interval in between for two times a day for 3 months |
| Intervention |
Group1d |
A total of 29 participants will perform Kegel exercise with pressure sensor probe withhold time of 10 seconds and rest interval of 10 seconds of 3 sets of 10 maximum contraction for 3 months |
| Comparator Agent |
Group2a |
A total of 29 participants will perform Kegel exercise in supine position In this group participants will perform exercise through verbal instructions only Three sets of eight maximal contraction withhold time of 6 to 8 seconds rest interval of 6 seconds in between for a total duration of 3 months |
| Comparator Agent |
Group2b |
A total of 29 participants will perform Kegel exercise through verbal instruction only Participants will squeeze pelvic floor muscle for 5 seconds followed by rest interval of 15 seconds of 3 sets of 15 voluntary contraction two times a day for 3 months |
| Comparator Agent |
Group2c |
A total of 29 participants will perform Kegel exercise through verbal instructions only. Participants will instruct to perform to perform 25 maximum contractions of 3 sets of Kegel exercise with 3 seconds of squeeze and 3 seconds of rest interval in between for two times a day for 3 months |
| Comparator Agent |
Group2d |
A total of 29 participants will perform Kegel exercise through verbal instruction only Participants will squeeze pelvic floor muscle for 10 seconds with rest interval of 10 seconds of 3 sets of 10 maximum contraction for 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Females suffering from Urinary Incontinence as assessed by International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form
Only Married Females |
|
| ExclusionCriteria |
| Details |
Pregnancy
Nulliparous
Any neurological disorders like multiple sclerosis Muscular dystrophy
Refused to perform Kegel exercise
Any Urogenital infection
Vaginal inflammation
Any systemic disorders
Any history of trauma to lower abdominal area |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form |
Two point measurements
On Preintervention Day 1 and On Postintervention day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| International Consultation on Incontinence Questionnaire Lower Urinary Tracts Quality of life |
Two point measurements
On Preintervention Day 1 and On Postintervention day 90 |
|
|
Target Sample Size
|
Total Sample Size="230"
Sample Size from India="230"
Final Enrollment numbers achieved (Total)= "232"
Final Enrollment numbers achieved (India)="232" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
03/06/2025 |
| 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)
|
Completed |
| 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
|
The study will be designed as a single center study. Participants who will be satisfy the selection criteria will be made part of the study. A sensor-based pressure probe capable of measuring the strength and performance of the pelvic floor muscle will be prepared. The study will be carried on 230 females which will be allocated into 4 groups as Group A, Group B, Group C and Group D that is 58 in each group. Then in each group 58 participants is further divided into intervention group and control group so 29 participants in each group. In all intervention group participants will perform Kegel exercise with sensor based pressure probe whereas in control group participants will perform Kegel exercise through verbal instructions only. The pressure sensor probe will be inserted into vagina allowing the transmission of pressure reading of pelvic floor muscle along with duration of contraction. The inserted probe will be covered with a sterile latex sleeve for each female. So, this present study is aimed to find out the optimal dosage of Kegel exercises in terms of contract- relax time as well as number of repetitions using sensor based pressure probe. |