Mirabegron plus solifenacin versus solifenacin only in females with overactive bladder
- Conditions
- Health Condition 1: N33- Bladder disorders in diseases classified elsewhereHealth Condition 2: N328- Other specified disorders of bladder
- Registration Number
- CTRI/2022/08/045082
- Lead Sponsor
- Intas Pharmaceuticals limited Corporate House Nr Sola Bridge S G Highway Thaltej
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Adult females more than 18 years of age suffering from symptoms of overactive bladder ( with eight or more micturition per 24 h and one urgency episode or more per 24 h with or without incontinence) for last 3 months
2. Patients with or without receiving any form of hormone replacement therapy
1. Patients with acute urinary tract infections will not be recruited for the time being However, after completion of successful treatment, if the patient qualifies for the recruitment she will be considered.
2. Patients with known case of narrow angle glaucoma or other urinary pathologies promoting retention of urine or any other contraindication to the study medicines like gastric retention , severe uncontrolled hypertension (more than 180/110) or history of diagnosed cardiac arrhythmias will not be considered for recruitment
3. Any known allergy to the study medication
4. Pregnant or lactating women
5, Severe renal or hepatic compromise
As this is an effectiveness and safety study in real life situation involving already marketed drugs, no list of prohibited medications are provided. This is the discretion of the study physicians to prescribe and reconcile according to the situational demand.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method