Better treatment option in mirabegron-solifenacin combination and their monotherapies.

A Prospective open label study to evaluate the safety, efficacy and tolerability of mirabegron with solifenacin combination compared to their monotherapies in overactive bladder patients. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2023/10/058595

Enrollment

172

Registered

2023-10-12

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N328- Other specified disorders of bladder

Interventions

Intervention1: Combination of Mirabegron and Solifenacin: Mirabegron 25mg and Solifenacin 5mg Once a day for 3 months Control Intervention1: Mirabegron: Mirabegron 25mg Once a day for 3 months Contro

Eligibility

Inclusion criteria

Inclusion criteria: OAB symptoms since 3 weeks 1 week drug free period for OAB treatment (mirabegron remains 5-6 days to be completely eliminated from the body [18]) Newly diagnosed OAB patient Patients of both gender

Exclusion criteria

Exclusion criteria: Known case of Pregnant and lactating women Neurogenic bladder Patient with significant stress/ urge UTI, prostatis, interstitial cystitis, bladder stone, malignant pelvic disease Urinary retention End Stage Renal Disease Diabetic nephropathy Uncontrolled Hypertension[14] (Systolic pressure =180mmHg and diastolic pressure =110mmHg)

Design outcomes

Primary

Measure	Time frame
Efficacy, tolerability and safety of mirabegron with solifenacin combination compared to their monotherapy.Timepoint: Total 3 months FollowUp at 4th week and 12th week	—

Secondary

Measure	Time frame
To assess the total cost burden for each treatment group.Timepoint: 3 months	—

Countries

India

Contacts

Public ContactDr Muhammed Munavvir

Yenepoya Medical College

24849@yenepoya.edu.in7356499845

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026