| CTRI Number |
CTRI/2025/06/088001 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
02/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on yoga therapy in patients with stress urinary incontinence after undergoing robotic radical prostatectomy |
|
Scientific Title of Study
|
Evaluating the Impact of Yoga Therapy on Stress Urinary Incontinence in Patients Who Have Undergone Robotic Radical Prostatectomy: A Randomized Controlled Trial |
| 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 Prajwal Rao K R |
| Designation |
MD Scholar |
| Affiliation |
S-VYASA yoga university |
| Address |
Svyasa yoga university, Prashanti kutiram, school of yoga and naturopathy, MD department
Bangalore KARNATAKA 560105 India |
| Phone |
09481320921 |
| Fax |
|
| Email |
prajwalraokr@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prajwal Rao K R |
| Designation |
MD Scholar |
| Affiliation |
S-VYASA yoga university |
| Address |
Svyasa yoga university, Prashanti kutiram, school of yoga and naturopathy, MD department
Bangalore KARNATAKA 560105 India |
| Phone |
09481320921 |
| Fax |
|
| Email |
prajwalraokr@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prajwal Rao K R |
| Designation |
MD Scholar |
| Affiliation |
S-VYASA yoga university |
| Address |
Svyasa yoga university, Prashanti kutiram, school of yoga and naturopathy, MD department
Bangalore KARNATAKA 560105 India |
| Phone |
09481320921 |
| Fax |
|
| Email |
prajwalraokr@gmail.com |
|
|
Source of Monetary or Material Support
|
| S-VYASA yoga university, Prashanti kutiram, Vivekananda road, Kallabalu post, Jigani, Bengaluru, Karnataka, India, 560105 |
|
|
Primary Sponsor
|
| Name |
Dr Prajwal Rao K R |
| Address |
S-VYASA yoga university, Prashanti kutiram, Vivekananda road, Kallabalu post, Jigani, Bengaluru, 560105 |
| 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 |
| Dr Saurabh Bhargava |
Narayana Hrudayalaya |
Narayana Health city, Mazumdar Shaw Medical Center, Department of Urology, opd section, Bommasandra, Anekal, Bengaluru Bangalore KARNATAKA |
9663179811
saurabh.bhargava.dr@narayanahealth.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe (IEC)-SVYASA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Education programme |
Education on urinary incontinence for 3 months |
| Intervention |
Yoga therapy |
Yoga therapy for urinary incontinence 3 sessions per week for 3 months |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Male |
| Details |
Male patients aged 50 to 75 years. Patients who have undergone robotic radical prostatectomy. Experiencing stress urinary incontinence as confirmed by clinical assessment. Willing to participate in a 3 month yoga intervention.
|
|
| ExclusionCriteria |
| Details |
Individuals with previous yoga experience within the last 6 months. Presence of other severe urological or neurological disorders. Patients with severe cognitive impairment like dementia. Patients with uncontrolled medical conditions such as uncontrolled hypertension, uncontrolled diabetes, or severe cardiovascular disease. Patients with severe physical limitations or disabilities. Individuals with a history of regular yoga practice
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Severity and symptoms of urinary incontinence |
At baseline and at 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
3 months |
|
|
Target Sample Size
|
Total Sample Size="76" Sample Size from India="76"
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)
|
10/06/2025 |
| 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="0" Months="5" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a randomized controlled trial aiming to evaluate the effectiveness of a validated yoga intervention on stress urinary incontinence (SUI) in patients who have undergone robotic radical prostatectomy (RARP). SUI is a common postoperative complication, significantly impacting quality of life. The intervention involves a 3-month yoga module tailored for prostate health, including postures, breathing techniques, and relaxation practices. The study will recruit male patients aged 50–75 years diagnosed with SUI at Narayana Health, Bengaluru. Objective (Pad test) and subjective (IIQ-7 questionnaire) assessments will be used to evaluate outcomes. The findings aim to explore yoga’s potential as an effective, low-cost, and integrative approach in post-prostatectomy rehabilitation. |