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Comparison of Daily versus Alternate-Day Tamsulosin Treatment in Men with Enlarged Prostate and Urinary Symptoms

Outcomes of alternate day vs daily Tamsulosin therapy for lower urinary tract symptoms due to Benign Prostatic Hyperplasia: A Randomized Controlled Study - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/111498
Enrollment
120
Registered
2026-06-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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: Alternate-day Tamsulosin therapy: Drug: Tamsulosin 0.4mg capsule/tablet Dose: 0.4mg orally every alternate day Duration: 6 months follow-up after randomization Control Intervention1: Da

Sponsors

Dr Digvijay Singh Tanwar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male patients aged more than 50 years. 2. Clinically and radiologically confirmed BPH. 3. Patients who have shown improvement in LUTS after 4 weeks of daily tamsulosin therapy. 4. Patients willing to participate and giving written informed consent

Exclusion criteria

Exclusion criteria: 1. History or evidence of carcinoma prostate. 2. Prior prostate or urethral surgery. 3. Urethral stricture, neurogenic bladder, or active urinary tract infection. 4. Patients on concomitant medications such as 5 alpha reductase inhibitors, anticholinergics, or phosphodiesterase-5 inhibitors. 5. Severe systemic illness (example-hepatic, renal, or cardiac failure). 6. Known hypersensitivity to tamsulosin.

Design outcomes

Primary

MeasureTime frame
Change in International Prostate Symptom Score (IPSS) and maximum urinary flow rate (Qmax) from baseline after randomizationTimepoint: 1, 3, and 6 months.

Secondary

MeasureTime frame
Change in post-void residual urine volume (PVR)Timepoint: 1, 3, and 6 months.;Incidence of adverse effects (dizziness, postural hypotension, fatigue, ejaculatory dysfunction) during follow-up.Timepoint: 1, 3, and 6 months.;Patient satisfaction/compliance during follow-up.Timepoint: 1, 3, and 6 months.;Recurrence or worsening of LUTS assessed by IPSS score.Timepoint: 1, 3, and 6 months.

Countries

India

Contacts

Public ContactDigvijay Singh Tanwar

AIIMS Jodhpur

drshivnavriya2004@gmail.com9958365510

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026