Effect of certain unani drugs in stress urinary incotinence in reproductive age women

Completed

• Conditions: Women with stress urinary incontinence

• Registration Number: CTRI/2014/09/004997
• Lead Sponsor: National Institute of Unani Medicine

Brief Summary

Stress urinary incontinence (SUI) is a major health problem affects 50% women and also frequently associated with women of childbearing age. It has substantial and important effects on health-related quality of life. The objectives were to assess the efficacy and safety of combination of oleo-gum-resin, kundur (Boswellia serrata) and root of nagarmotha (Cyperus scariosus) plus pelvic floor muscle training (PFMT) in the treatment of SUI in reproductive age women and improvement in their health related quality of life (HRQOL).

A prospective, single-blind, placebo-controlled, randomized clinical trial was conducted from March 2012 to Feb 2013. In the test (n=30) and placebo group (n=30), combination of kundur and nagarmotha (equal quantity), 2 g twice daily plus PFMT and placebo (cellulose) plus PFMT respectively was administered for 8 weeks. The primary outcomes were one hour pad test and cough stress test. The secondary outcome was HRQOL assessed by ICIQ-SF questionnaire. The result of primary outcome was divided into cured, improved and failed. The results were analyzed using parametric and nonparametric with 5% significance.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-22
• Study Completion: 2013-05-02
• Last Update Posted: 2019-11-12

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 147

Inclusion Criteria

• Parous women aged 18-55 years.
• Patients identified having symptom of predominant stress urinary incontinence with or without grade 1, 2 and 3 genital prolapse with Valsalva maneuver.
• Patients with an average daytime voiding interval >2 h, and nocturnal voiding frequency ≤ 2 per day and a positive cough stress test (supine full bladder) observed on physical examination at visit 1.

Exclusion Criteria

• Patients with systemic and endocrine diseases like asthma, tuberculosis, diabetes mellitus, uncontrolled hypertension etc.
• Patients with any pelvic pathology, malignancy, fistula, enuresis and continuous leakage of urine and on pharmacological treatment for symptoms of urinary incontinence in preceding one month and continence surgery within 6 months were excluded.Pregnant and lactating women and83patients with obstruction of urethra, cognitive and psychiatric impairment and drug treatment for depression.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure was changes in stress test and one hour pad test	At baseline and after 8 weeks (post test)

Secondary Outcome Measures

Name	Time	Method
The secondary outcome (subjective parameter) was change in quality of life assessed by ICIQ-SF questionnaire	Every 2 weeks during treatment of 8 weeks and once after 4 weeks following treatment for one month

Trial Locations

Locations (1)

National Institute of Unani Medicine; 🇮🇳 Bangalore, KARNATAKA, India

National Institute of Unani Medicine

🇮🇳Bangalore, KARNATAKA, India

Padmaja AR

Principal investigator

9242137366

padmajaamruth@gmail.com