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OpenTrials
Active, not recruiting

NCT Number: NCT07815379

Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

BPH (Benign Prostatic Hyperplasia) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Urology and Nephrology Center, Mnasoura University

Al Mansurah, Dakahlia Governorate, 35561, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

alpha blocker monotherapy Tamsulosin

Drug

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

Drug

BPH patients are given dual alpha blockers compared to single alpha blocker drug

Primary outcomes

  1. IPSS change

    Time frame: 3 months

    IPSS score change at 1 and 3 months following drug adminstration

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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