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Active, not recruiting Phase 4

Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction

NCT07815379 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 4
Started
2025-10-12
Last updated
2026-09-11

Condition(s) studied

BPH (Benign Prostatic Hyperplasia)

Investigational drug(s) / intervention(s)

alpha blocker monotherapy Tamsulosinalpha blockers Tamsulosin and Silodosin

alpha blocker monotherapy Tamsulosin: Effect of Tamsulosin and placebo in Management of Lower Urinary Tract Symptoms and Acute Urine Retention in Patients with Benign Prostatic Hyperplasia.

alpha blockers Tamsulosin and Silodosin: BPH patients are given dual alpha blockers compared to single alpha blocker drug

Study summary

Failed medical treatment to alleviate LUTS and AUR is an indication for intervention, some trials were published elucidating the possible use of standard dose tamsulosin and silodosin and double dose tamsulosin but to the best of our knowledge, no studies with head-to-head comparison between Tamsulosin and Combination of Tamsulosin and Silodosin for Management of Lower Urinary Tract Symptoms and Acute Urine Retention in Patients with Benign Prostatic Hyperplasia.

Eligibility

Sex
MALE
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Age ≥40 years. Catheterized patients due to acute urine retention secondary to BPO. Patients with moderate and severe LUTS secondary to BPH as proven by IPSS (International Prostate Symptoms score) ≥8 and Qmax \<15 ml/sec with total void urine volume \>125 cc. Exclusion Criteria: Patients with neurological problems as: uncontrolled DM, parkinsonism and cerebral stroke. Patients with history of previous prostate surgery. Patients with complicated BPH necessitating intervention as: recurrent/persistent UTI, recurrent hematuria, bladder stones and indwelling urethral catheter due to chromic urine retention (CUR). Patients with suspected malignancy by abnormal Digital Rectal Examination (DRE) and or high PSA.

Primary outcome measure(s)

  • IPSS change — 3 months
    IPSS score change at 1 and 3 months following drug adminstration

Trial sites (1)

FacilityCityRegionStatus
Urology and Nephrology Center, Mnasoura University Al Mansurah Dakahlia Governorate
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07815379 on ClinicalTrials.gov ↗ ← All trials in Egypt