Health Condition 1: N394- Other specified urinary incontinence
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patients of age group 30 to 45 years with signs and symptoms of Urinary incontinence 2.UI symptoms of at least 6 months duration 3.24 Hour pad weight greater than 3 g during the screening period 4.A minimum of 1 and no more than 15 UI episodes on any single day and no fewer than 9 total UI episodes over 3 days during the screening period
Exclusion criteria
Exclusion criteria: 1. Patients with congenital anomalies of genitourinary system. 2. Patients with Uterine prolapse 3. Patients with carcinoma of cervix 4. Patients with systemic diseases which may interfere with the course of treatment. 5. Gravid women 6. History of Surgery/Assisted labor 7. History of urethral diverticula; History of urethral sling or anterior prolapse repair 8. Treatment with urethral bulking agents and/or other UI procedure or surgery within the 6 months prior to the Screening Visit 9. Known vesicoureteral reflux, vaginal prolapse beyond the introitus, or other significant pelvic floor abnormalities 10. Urinary incontinence of neurogenic etiology 11. Morbidly obese (body mass index 40 or greater) 12. Chronic hepatitis 13. Hepatic cirrhosis 14. Evidence of active infection with hepatitis B or hepatitis C 15. History of human immunodeficiency virus (HIV) infection
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Improved quality of life in patients with urine incontinence & recording of potential ADR if any, though not expected.Timepoint: At baseline, 30th day, 60th day, 90th day | — |
Primary
| Measure | Time frame |
|---|---|
| Reduction in signs and symptoms of Urinary incontinence graded through RUIS ScaleTimepoint: At baseline, 30th day, 60th day, 90th day | — |
Countries
India
Contacts
Sri Chandrasekharendra Saraswathi Viswa Mahavidyalaya