An open label double arm clinical study to compare the effect of kegel exercise with and without Baladi choorna in women with mild to moderate stress urinary incontinence.
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Amrita School Of Ayurveda
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Reduction in quantity of urine leakage by 1 hour pad test by weighing the pad
Overview
Brief Summary
This study is a open-label double arm clinical study to compare the effect of Kegel exercise with and without 6gm of Baladi curna twice daily for a period of 56 days in Women with Mild to Moderate Stress Urinary Incontinence. The study will be conducted in the OPD and IPD of Striroga and Prasuti tantra Deoartment of Amrita School of Ayurveda, Kollam, India. The primary outcome measures will be reduction in quantity of urine leakage assessed by 1 hour pad test by weighing the pad, and the secondary outcome will be improvement in Quality of Life by ICIQ-LUTS QoL Questionnaire. The assessment for both will be done on Day 1 and Day 57.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- None
Eligibility Criteria
- Ages
- 40.00 Year(s) to 70.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Parous women of age from 40 to 70 years.
- •Positive on cough stress test with simultaneous expulsion of urine along with cough.
- •Positive pad test with gain of greater than 1 g in the 1-hour pad test.
Exclusion Criteria
- •Participants with clinical presentation of other type of incontinence like, UUI, MUI Participants diagnosed with stress urinary incontinence associated with pelvic organ prolapse and hysterectomy.
- •Participants diagnosed of Urinary Tract Infection.
- •Participants diagnosed with Diabetes Mellitus.
- •Participants allergic towards milk.
- •Participants with urine leakage of greater than or equal to 50gm on 1 hour pad test.
Outcomes
Primary Outcomes
Reduction in quantity of urine leakage by 1 hour pad test by weighing the pad
Time Frame: Assessment by 1 hour pad test by weighing the pad is done on Day 1 and Day 57
Secondary Outcomes
- Improvement in Quality of Life by ICIQ-LUTS QoL Questionnaire(Assessment by ICIQ-LUTS QoL Questionnaire is done on Day 1 and Day 57)
Investigators
Dr Sandra K S
Amrita School Of Ayurveda