To study and compare effectiveness and safety of mirabegron(used for treatment of overactive bladder) and mirabegron plus vitamin D3 in adult patients o overactive bladder.

Efficacy and safety of mirabegron plus vitamin D vs mirabegron alone in the treatment of adult patients of overactive bladder: A randomized controlled trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/048061

Enrollment

Registered

2022-12-13

Start date

Unknown

Completion date

Unknown

Last updated

2023-01-09

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: Mirabegron: Used for treatment of overactive bladder. will be given in 50 mg OD dose for 12 weeks. Control Intervention1: Vitamin d3 plus mirabegron. : Vitamin d3 sachet will be given t

Eligibility

Inclusion criteria

Inclusion criteria: patients with OAB severity between 2 and 3 on USS

Exclusion criteria

Exclusion criteria: 1. Subjects with severe deficiency of Vitamin D (Vitamin D levels 2. PVR >=150 ml 3. Subject having history suggestive of urinary tract infections (UTI), catheterized subjects and subject with obstructive symptoms 4. Subject with history suggestive of hypertension, diabetes mellitus, diabetes insipidus, renal disease and nervous system disorders 5. Subject with history suggestive of glaucoma 6. Subject with stress urinary incontinence and neurogenic bladder 7. Subjects already taking treatment for OAB 8. Subject having history of adverse reaction to drugs to be used in study 9. Pregnant and lactating females 10. Subject refusing to give consent

Design outcomes

Primary

Measure	Time frame
Urgency severity score, Overactive bladder severity score, patient perception of bladder control score, 3 days voiding diaryTimepoint: Scores will be measured and compared at baseline, 4 weeks, 8 weeks and 12 weeks	—

Secondary

Measure	Time frame
Kings health questionnaireTimepoint: 12 weeks	—

Countries

India

Contacts

Public ContactDr Seema Rani

BPS GMC, Khanpur Kalan, Sonepat

vks.skv@gmail.com8607442457

Outcome results

None listed

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