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A clinical trial to study the effect of two drugs, silodosin and silodosin with tadalafil, in Lower Urinary Tract Symptoms patients with Benign Prostatic Hyperplasia

Comparison of Silodosin Monotherapy vs FDC of Silodosin with Tadalafil in the Management of LUTS associated with BPH : An Open-Label Randomized Controlled Trial - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079116
Enrollment
60
Registered
2025-01-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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 8mg with Tadalafil 5mg: Silodosin 8mg with Tadalafil 5mg per day 3 months to 6 months Control Intervention1: Silodosin: Silodosin 8mg per day 3 months to 6 months

Sponsors

Harshavardhan K
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Aged above 50 years 2. Participants must have a clinical diagnosis of BPH with at least moderate LUTS, indicated by an International Prostate Symptom Score (IPSS) of 8 or higher, and a peak urinary flow rate (Q max) of 15 ml/sec or less 3. A post-void residual (PVR) volume of up to 200 ml 4. Provided inform consent and agreed to follow study protocols.

Exclusion criteria

Exclusion criteria: 1. Participants with any history of prostate cancer or recent prostate surgeries 2. Severe hepatic or renal impairment 3. Cardiovascular conditions such as recent myocardial infarction, stroke, or uncontrolled blood pressure, severe arrythmia, hypotension or orthostatic hypotension 4. Urological conditions like neurogenic bladder, bladder stones, or recurrent urinary tract infections 5. Hypersensitivity to either silodosin or tadalafil 6. substance abuse 7. Presence of Non- arteritic anterior ischemic optic neuropathy 8. Retinitis pigmentosa 9. Concurrent use of nitrates or nitroprusside

Design outcomes

Primary

MeasureTime frame
1.The study is to measure the change in IPSS from baseline to 12 weeks. 2.To provide rapid and optimal relief from the symptoms. 3.To reduce the prostatic smooth muscle size.Timepoint: Visit 1- On Day 1, Baseline Visit 2- 2nd week Visit 3- 6th week Visit 4- 12th week—

Secondary

MeasureTime frame
1.Evaluate improvements in quality of life related to urinary symptoms. 2.Assess post-void residual volume to evaluate bladder emptying efficiency. 3.Monitor and compare the incidence of adverse events to evaluate the safety profiles of both treatment regimens (Silodosin 8mg monotherapy vs. FDC of Silodosin 8mg with Tadalafil 5mg). 4.If the symptoms worsen, patient to be managed with surgical procedures.Timepoint: Visit 1- On Day 1, Baseline Visit 2- 2nd week Visit 3- 6th week Visit 4- 12th week—

Countries

India

Contacts

Public ContactDr Jagadeeshan

SRM medical college hospital and research centre.

jagadeem1@srmist.edu.in7449277556

Outcome results

None listed

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