| CTRI Number |
CTRI/2025/07/090121 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
Effect of yogasana and kegel exercise in urinary problems of women |
|
Scientific Title of Study
|
A STUDY ON EVALUATION OF EFFECTS OF YOGASANA (TITALIASANA AND UTTKATASANA) VERSUS KEGEL EXERCISE IN CASES Of OVER ACTIVE BLADDER AND URINARY INCONTINENCE IN FEMALES |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sheetal Singh |
| Designation |
Ph.D Scholar |
| Affiliation |
|
| Address |
Department of Shalya Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University
Varanasi UTTAR PRADESH 221005 India |
| Phone |
6388056415 |
| Fax |
|
| Email |
sheetal.shiva@bhu.ac.in |
|
Details of Contact Person Scientific Query
|
| Name |
Arun Kumar Dwivedi |
| Designation |
Assistant Professor |
| Affiliation |
|
| Address |
Department of Shalya Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University
Varanasi UTTAR PRADESH 221005 India |
| Phone |
9451050860 |
| Fax |
|
| Email |
drarunbhu@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sheetal Singh |
| Designation |
Ph.D Scholar |
| Affiliation |
|
| Address |
Department of Shalya Tantra, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University
Varanasi UTTAR PRADESH 221005 India |
| Phone |
6388056415 |
| Fax |
|
| Email |
sheetal.shiva@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Banaras Hindu University,Varanasi, Uttar pradesh, Pin code-221005, India |
|
|
Primary Sponsor
|
| Name |
University Grant Commission |
| Address |
Bahadur Shah Zafar Marg, New Delhi |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Shalya Tantra Faculty of Ayurveda Institute of Medical Science BHU Varanasi |
Banaras Hindu University, Varanasi, Uttar Pradesh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arun Kumar Dwivedi |
Banaras Hindu University |
Department of Shalya Tantra Faculty of Ayurveda Institute of Medical Science Banaras Hindu University Varanasi Varanasi UTTAR PRADESH |
9161499774
drarunbhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University Institute of Medical Sciences Institutional Ethics Committee Varanasi 221005 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N80-N98||Noninflammatory disorders of female genital tract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Yoga protocal |
50% of the cases will undergo kegel exercise of the study and rest 50% will go under titaliasana and uttkatasana |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Females aged 30-60 years, diagnosed with OAB AND UI in the outpatient department (OPD) and IPD, IMS BHU
Experiencing symptom for the last 2 months
Willing to participate and follow the intervention protocol.
|
|
| ExclusionCriteria |
| Details |
female age less than 30 and more than 60 .• Pregnant or Postpartum Women (within 6 months postpartum) • History of Pelvic Surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| OAB Symptom Severity and Urinary Incontinence Severity. |
8 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life |
8 week |
|
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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)
|
16/07/2025 |
| 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="3" Months="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Overactive bladder OAB and urinary incontinence UI are common conditions in both men and women, especially increasing with age. OAB involves frequent urgency, nocturia, and sometimes urge incontinence. UI refers to involuntary urine leakage and can be classified into types such as stress, urge, mixed, overflow, and functional incontinence. Women are more affected than men, with factors like childbirth, obesity, and aging increasing risk. These conditions negatively impact physical health, emotional well-being, and quality of life by causing infections, falls, embarrassment, and mental stress.
Yoga is being explored as a noninvasive method to manage OAB and UI. It strengthens pelvic muscles, reduces stress, and improves neuromuscular coordination. Studies have shown that yoga practices like Tadasana, Utkatasana, and Trikonasana improved muscle strength, reduced symptoms, and enhanced quality of life in women. Kegel exercises are also widely recommended to strengthen pelvic floor muscles and reduce UI symptoms. Research comparing both methods shows promising results but lacks standardization and head-to-head trials.
The study aims and objectives is to evaluate the effectiveness of Yogasana Titaliasana and Utkatasana versus Kegel exercises in the management of overactive bladder OAB and urinary incontinence UI in females, focusing on symptom reduction, quality of life, and healthcare resource utilization, To evaluate changes in quality of life. And To provide evidence-based recommendations for integrating Yogasana as a non-invasive, cost-effective treatment alternative for OAB and UI in clinical and community settings. Null Hypothesis of the study is-There is no significant effect in the efficacy of yogasanas vs Kegel exercises in the management of Overactive Bladder and Urinary Incontinence in females. and alternative Hypothesis is-There is a significant effect in the efficacy of yogasanas vs Kegel exercises in the management of Overactive Bladder and Urinary Incontinence in females. And Research variable is Dependent – OAB symptoms, UI severity, Quality of life. Independent – Yogasanas Titaliasana and uttkatasana, and Kegel exercises. This study will involve 100 women divided into two groups Group A will perform Kegel exercises and Group B will perform the selected yoga poses for eight weeks. Outcomes will be measured using standard tools like OAB symptom score, ICIQ-UI SF, and Kings Health Questionnaire. Participants must meet certain criteria and avoid certain health conditions that could affect results.
Group A will be taught traditional Kegel exercises aimed at strengthening pelvic floor muscles through repeated contractions. Group B will perform yogasanas including Titaliasana a seated pose for inner thigh relaxation and Utkatasana a squatting pose for strength and balance. Both groups will follow a supervised 8-week protocol with daily practice. Follow-up assessments will evaluate changes in symptoms and overall well-being.
This study addresses a gap in evidence and aims to help healthcare providers choose effective and patient-friendly treatments. Yoga may offer a low-cost and sustainable option for managing OAB and UI, reducing reliance on medication and invasive procedures. |