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Night-time frequency in men above 50 years with LUTS/BPH: Prevalence, its predictive factors and association with nocturnal polyuria and comparative analysis of outcome after tamsulosin or silodosin therapy

Nocturia in men aged above 50 years with LUTS/BPH: Prevalence, its predictive factors and association with nocturnal polyuria and comparative analysis of outcome after tamsulosin or silodosin therapy by doing an open label randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026619
Enrollment
500
Registered
2020-07-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: Tamsulosin: All included patients will be randomly divided into two groups: Group S (silodosin treatment) and Group T (Tamsulosin treatment) based on the flip of the coin. Patients will

Sponsors

King George Medical University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All men aged > 50 years with LUTS/BPH for at least 3 month duration having IPSS score of 8 or greater.

Exclusion criteria

Exclusion criteria: 1. Prostate cancer, 2. PSA > 4 ng/ml, 3. Urinary tract infection 4. Patients with h/o AUR or PUC placement or patients who are on PUC 5. Patients having renal failure or upper urinary tract dilatation. 6. Patients with h/o hematuria 7. Stricture urethra 8. Bladder calculus 9. Patients with GUTB 10. Patients with LUTS who are already on α-blockers within the past 1 month. 11. nervous system disease, 12. urolithiasis, 13. medical therapy that could affect the function of urination, 14. prostatic surgery, or pelvic surgery

Design outcomes

Primary

MeasureTime frame
To compare the efficacy of tamsulosin and silodosin at 4 weeks in improving the nocturia in elderly men with LUTS/BPH.Timepoint: 4 weeks—

Secondary

MeasureTime frame
1. To evaluate the prevalence of nocturia in men aged 50 years with LUTS/BPH. 2. To evaluate the predictive factors of nocturia in men aged50 years with LUTS/BPH. 3. To evaluate the relation between nocturia and nocturnal polyuria . Timepoint: 4 weeks—

Countries

India

Contacts

Public ContactGyanendra Singh

Department of Urology, King George Medical University

drapul.goel@gmail.com9839181465

Outcome results

None listed

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