| CTRI Number |
CTRI/2024/06/068688 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
03/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of combining Yoga therapy with Pelvic muscle training to treat inability to hold urine in women on outdoor basis. |
|
Scientific Title of Study
|
Effect of Medical Yoga therapy along with Pelvic Floor Muscle Training (PFMT) for Stress Urinary Incontinence (SUI) women attending tertiary care hospital OPD, West Bengal. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1295-8676 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mala Bhowmik |
| Designation |
Nursing Officer |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
HOD room, 5th floor, Urology department, Uro-Nephro building, SSKM Hospital, Acharya Jagadish Chandra Bose Rd, Bhowanipore, Kolkata
West Bengal
Kolkata
WEST BENGAL
700020
India |
| Phone |
9735913451 |
| Fax |
|
| Email |
bhowmikmala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mala Bhowmik |
| Designation |
Nursing Officer |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
HOD room, 5th floor, Urology department, Uro-Nephro building, SSKM Hospital, Acharya Jagadish Chandra Bose Rd, Bhowanipore, Kolkata
West Bengal
Kolkata
WEST BENGAL
700020
India |
| Phone |
9735913451 |
| Fax |
|
| Email |
bhowmikmala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeyadeepa R |
| Designation |
Principal |
| Affiliation |
IQ City Institute of Nursing Sciences |
| Address |
IQ City Road, Durgapur, West Bengal
Barddhaman
WEST BENGAL
713206
India |
| Phone |
08921698754 |
| Fax |
|
| Email |
r.jeyadeepa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Urology department.
Institute of Post Graduate Medical Education and Research and SSKM Hospital.
Acharya Jagadish Chandra Bose Rd, Bhowanipore, Kolkata, West Bengal 700020. |
|
|
Primary Sponsor
|
| Name |
Mala Bhowmik |
| Address |
5th floor, Urology building, IPGMER and SSKM Hospital, Acharya Jagadish Chandra Bose Rd, Bhowanipore, Kolkata, West Bengal 700020. |
| 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 Debansu Sarkar |
Institute of Post Graduate Medical Education and Research and SSKM Hospital |
Room no.-10,Ground floor, Uro-nephro building, Department of Urology. Acharya Jagadish Chandra Bose Rd, Bhowanipore, Kolkata, West Bengal 700020.
Kolkata
WEST BENGAL |
9830010826
drdebansu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME and R Research Oversight Committee (Institutional Ethics Committee, Institute of Post Graduate Medical Education and Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N393||Stress incontinence (female) (male), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Medical Yoga therapy along with Pelvic Floor Muscle Training (PFMT) |
Medical yoga: A set of unique 21 postures, one day (60 min duration) per week directly supervised session for 8 weeks along with daily practice of postures at home will be considered as Yoga in this study.
Pelvic Floor Muscle Training (PFMT): In this study The PFMT will be defined as pelvic floor muscle contractions (per contraction will be for 3 to 5 seconds,10 to 15 repetitions in one set, such minimum 3 sets daily for 8 weeks).
|
| Comparator Agent |
Pelvic Floor Muscle Training (PFMT) |
Pelvic Floor Muscle Training (PFMT): In this study The PFMT will be defined as pelvic floor muscle contractions (per contraction will be for 3 to 5 seconds,10 to 15 repetitions in one set, such minimum 3 sets daily for 8 weeks). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
i. Ambulatory women with the age group between 18 yrs to 60 yrs.
ii. History of involuntary loss of urine for at least 3 months that is a social or hygienic problem.
iii. Documented for minimum 3 episodes of incontinence on a screening 3-day voiding diary.
iv. Participants also agreed to be refrain from other treatment related to incontinence during the trial period.
v. Positive cough stress test.
vi. Women residing within 100 km in radius.
vii. History of stress urinary incontinence according to International Continence Society (ICS).
viii. Urine leakage >4gm measured by pad test with standardized bladder volume.
ix. Willing to give consent for participation in study. They must be motivated to undertake yoga exercises if required.
x. Understands English/Hindi/Bengali.
|
|
| ExclusionCriteria |
| Details |
The women will be excluded if they,
I. Severe mobility limitation that would prevent from participating in yoga session. Eg. Inability to walk two blocks on level ground or unassisted getting up from supine to standing position within 10 seconds or inability to walk up a single stair.
II. Participants did not use practitioner-supervised pharmacological or clinical treatments for last 3 months.
III. Woman with UI having any of the following symptom’s pain or hematuria (assessed by urine dipstick testing), recurrent infections, interstitial cystitis or chronic pelvic pain, suspected or proven voiding problems, or significant pelvic organ prolapse.
IV. Abnormal bladder function (residual urine>50 ml and maximal uroflow <15ml/s).
V. Women who had delivered a baby in last 6 months.
VI. Women suffering from pelvic malignancy, h/o radical surgery and/or irradiation or anti-incontinent surgery/urethral surgery/or pelvic surgery.
VII. Those taking diuretics and/or excessive caffeine.
VIII. Women with neurological or psychiatric disorders, uncontrolled diabetes mellitus.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Average frequency of stress urinary incontinence episodes using validated 3-days voiding diary. |
Baseline, 4 weeks, 8 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Changes in the frequency of stress incontinence, any daytime incontinence, night-time incontinence, daytime voids in toilet, nighttime voids in toilet assessed by 3 days voiding diary.
2. Quality of life as measured by ICIQ-UI SF (International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence) Short Form.
|
Baseline, 4 weeks, 8 weeks |
1.Cough stress test
2. Pad test
3. Uroflowmetry.
4.USG |
Baseline, 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Problem statement: Effect of Medical Yoga therapy along with Pelvic Floor Muscle Training (PFMT) for Stress Urinary Incontinence (SUI) women attending tertiary care hospital OPD, West Bengal.
Objectives: a. Primary objective: To evaluate Effect of adding Medical yoga to Floor Muscle Training (PFMT) to treat Stress Urinary Incontinence (SUI) among women attending urology OPD. b. Secondary objectives: I. To assess impact of stress incontinence on quality of life. II. To find the association between symptoms score and selected demographic variables. Research hypothesis: H1: Effect of Yoga with PFMT will have significant effect on Stress Urinary Incontinence symptom score than only PFMT. H0: Effect of Yoga with PFMT will not have significant effect on Stress Urinary Incontinence symptom score than only PFMT. Timelines: Total duration is 3 years. Study participants: Stress Urinary Incontinence (SUI) affected women. Study design: Parallel open label randomized active controlled trial Number of groups to be studied, their names and definitions: Two group- Experimental (receiving PFMT and Yoga) and control group (receiving only PFMT). Population: Stress Urinary Incontinence (SUI) affected women. Sample: Stress Urinary Incontinence (SUI) affected women attending urology OPD in selected tertiary care hospital. Sampling method: Permuted block randomization, Fixed. Sample size: 200 in total and divided into two equal arm (Intervention group 100 and control group 100). List of variables: Demographic variables and clinical profile, incontinence-related Quality Of Life, Frequency and volume. Data collection tools: Structured questionnaire on Demographic variables and clinical profile, ICIQ-UI SF(International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence) Short Form to assess quality of life, ICIQ (International Consultation on Incontinence Modular Questionnaire) Bladder Diary to measure urinary frequency. Final Study setting: OPD of SSKM Hospital Self-funded study
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