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
Not Applicable
- Conditions
- Health Condition 1: N401- Benign prostatic hyperplasia withlower urinary tract symptoms
- Registration Number
- CTRI/2021/12/038658
- Lead Sponsor
- Sathaye Shekhar Ulhas
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparing outcome of Silodosin vs Silodosin plus Mirabegron for nocturia in patients of BEP/LUTS. <br/ ><br>Timepoint: Baseline, at 1 month, at 2 months
- Secondary Outcome Measures
Name Time Method 1.To assess difference in improvement of overall IPSS score between the two arms. <br/ ><br>2. To compare change in sleep quality using ICIQ-NQoL score <br/ ><br>3. To compare the adverse events in the two groups. <br/ ><br>Timepoint: Baseline, at 1 month, at 2 months