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Benefits of mirabegron as an add-on drug to the previously taking medications in patients suffering from excessive night time urination due to prostate enlargement

Comparing outcome of silodosin vs silodosin plus mirabegron for nocturia in patients of BEP/LUTS; a double blinded, randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/12/038658
Enrollment
152
Registered
2021-12-15
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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: Silodosin and mirabegron: Silodosin- alpha blocker, dosing of 8 mg once a day for 2 months to be taken orally Mirabegron- Beta 3 agonist, dosing of 50 mg once a day for 2 months to be t

Sponsors

Sathaye Shekhar Ulhas
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients presenting to urology OPD with complaints of nocturia with documented BEP at PGIMER, Chandigarh. 2.Patients willing to participate in the study. 3.Age greater than 40 years

Exclusion criteria

Exclusion criteria: 1.Prostate cancer 2.Any contraindication to use mirabegron 3.Recurrent UTI 4.Patients with H/O AUR or PUC placement or patients who are on PUC. 5.Bladder stones. 6.Stricture urethra. 7.Psychogenic polydipsia 8.Prostate surgery in the past. 9.Spinal cord trauma, spinal disease affecting bladder function. 10.Patient not willing to participate in study.

Design outcomes

Primary

MeasureTime frame
Comparing outcome of Silodosin vs Silodosin plus Mirabegron for nocturia in patients of BEP/LUTS. Timepoint: Baseline, at 1 month, at 2 months

Secondary

MeasureTime frame
1.To assess difference in improvement of overall IPSS score between the two arms. 2. To compare change in sleep quality using ICIQ-NQoL score 3. To compare the adverse events in the two groups. Timepoint: Baseline, at 1 month, at 2 months

Countries

India

Contacts

Public ContactSathaye Shekhar Ulhas

Post Graduation Institute of Medical Education and Research, Chandigarh

seeamol83@gmail.com9990245973

Outcome results

None listed

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