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A randomised trial comparing the effectiveness of oxybutynin and mirabegron in reducing symptoms of frequency and urgency in patients with benign prostatic hyperplasia receiving medical treatment with tamsulosin.

Comparison of the efficacy of oxybutynin with that of mirabegron as an add-on therapy to tamsulosin in patients with persistent storage symptoms presumed to be due to benign prostatic hyperplasia : A randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/10/021513
Enrollment
96
Registered
2019-10-03
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms

Interventions

Intervention1: Single-center, double blinded, double dummy placebo, randomized controlled trial.: TWO GROUPS STUDY GROUP 1 (MIRA GROUP): Patients taking mirabegron (50 mg tablet od plus inert placebo)

Sponsors

JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION RESEARCH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male patients aged 50 years or older with LUTS presumed to be due BPH having urinary urgency at least once per week and a total OAB symptom score (OABSS) � 3 points after � 8 weeks treatment with tamsulosin 0.4mg od

Exclusion criteria

Exclusion criteria: 1. PVR > 100 ml 2. Q max 3. Prior diagnosis of neurogenic bladder 4. Performance of clean intermittent catheterization, 5. Severe bladder diverticulum or urethral stricture, 6. Planning to have a child, 7. Suspected prostate or bladder malignancy 8. Previous urethral surgery or prior diagnosis of urethral stricture disease. 9. Previous intra pelvic irradiation, 10. Suspected recurrent urinary infection, 11. Presence of renal or hepatic impairment, 12. Taking medicines contraindicated or requiring dose adjustments in combination with mirabegron or oxybutynin 13. Patients who have taken mirabegron or any anticholinergic medication in the previous 4 weeks. 14. Judged to be unsuitable for the trial by doctors

Design outcomes

Primary

MeasureTime frame
Changes in baseline IPSS(international prostate symptom score ) and its sub scores , OABSS (overactive bladder symptoms score ) and its sub scores, PVR (post void residual urine), and PFR (peak flow rate) in Group Mira and Group Oxy.Timepoint: At enrollment, 4 weeks, weeks & 12 weeks—

Secondary

MeasureTime frame
Side effect profile & cause for treatment failureTimepoint: At enrollment, 4 weeks, weeks & 12 weeks—

Countries

India

Contacts

Public ContactDR L N DORAIRAJAN

JAWAHARLAL INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION & RESEARCH

dorairajan_ln@hotmail.com9442572804

Outcome results

None listed

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