Health Condition 1: N33- Bladder disorders in diseases classified elsewhere Health Condition 2: N328- Other specified disorders of bladder
Conditions
Interventions
Intervention1: Solifenacin (5mg )plus mirabegron (25mg): Tablet Solifenacin (5mg )plus mirabegron (25mg) once daily in one group for 3 months
Intervention2: solifenacin (5mg) plus mirabegron (50mg): T
Sponsors
Intas Pharmaceuticals limited Corporate House Nr Sola Bridge S G Highway Thaltej
Alembic Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Mean number of micturition per 24hrs 2. Change from baseline to end of treatment in mean volume voided per micturition (MVV ) 3. Incontinence and urgency episode per 24hrs 4. Mean Change in Postvoid residual volume(PVR) 5. Difference in medication adherence among three groups 6. Adverse effect profile among study subjects 7. Difference in quality of life parameters before and after the therapy among three groups Timepoint: All three groups will be followed up at monthly intervals for 3 months while they will be receiving the medications | — |
Secondary
| Measure | Time frame |
|---|---|
| NILTimepoint: NIL | — |
Countries
India
Contacts
Public ContactDr Rathindra Nath Ray
IPGME&R and SSKM Hospitals
Outcome results
None listed