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Safety And Efficacy of Tamsulosin and Silodosin in Patients of Benign Prostatic Hyperplasia

Safety And Efficacy of Tamsulosin and Silodosin in Patients of Benign Prostatic Hyperplasia: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/03/106496
Enrollment
130
Registered
2026-03-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: N400- Benign prostatic hyperplasia without lower urinary tract symptoms

Interventions

Intervention1: Tamsulosin: 0.4 mg capsules orally once daily at bedtime for 8 weeks. Control Intervention1: Silodosin: 8 mg capsules orally once daily at bedtime for 8 weeks.

Sponsors

Dr Pritkumar HIrani
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with BPH with an age of more than 40 years old come to the outpatient department (OPD), 2. International Prostate Symptom Score (IPSS) score of 8 and above, 3. Maximum flow rate of less than 10 ml/s.

Exclusion criteria

Exclusion criteria: 1. Patients with Neurogenic bladder, Bladder neck contracture, Stricture urethra, Bladder calculi, Active urinary tract infection, Prostate cancer, 2. Hemodynamically unstable patients, 3. Patients having an absolute indication for surgery, 4. Allergic to test drugs, 5. Not willing to participate in the study.

Design outcomes

Primary

MeasureTime frame
Change in IPSS score, maximum urinary flow rate, and residual urine volume between Group T and Group S.Timepoint: From baseline to follow-up at 8 weeks

Secondary

MeasureTime frame
Any side effects like dizziness, retrograde ejaculation, postural hypotension, and others reported by patients in both groups.Timepoint: From baseline to follow-up at 8 weeks

Countries

India

Contacts

Public ContactDr Sangita Gupta
sangitaarungupta57@gmail.com9829203024

Outcome results

None listed

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