Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction

NCT07815379 | Active Not Recruiting Phase 4

• 1 other identifier: MD.25.09.1037
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

BPH (Benign Prostatic Hyperplasia)

Keywords

BPH; alpha blockers; LUTS

Outcome Measures

Primary Outcomes (1)

• IPSS change

  IPSS score change at 1 and 3 months following drug adminstration

  3 months

Study Arms (2)

Single alpha blocker for BPH treatment

PLACEBO COMPARATOR

BPH patients in this arm are given single alpha blocker drug with placebo

Drug: alpha blocker monotherapy Tamsulosin

Double alpha blockers for BPH management

ACTIVE COMPARATOR

BPH patients in this arm are given double alpha blocker drugs

Drug: alpha blockers Tamsulosin and Silodosin

Interventions

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.

Single alpha blocker for BPH treatment

alpha blockers Tamsulosin and Silodosin DRUG

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

Double alpha blockers for BPH management

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center, Mnasoura University

Al Mansurah, Dakahlia Governorate, 35561, Egypt

Location

Related Publications (1)

• Osman T, Elawady H, Fawaz K, Shabayek M, Essam MD, Osman D, ElSaeed KO. Evaluation of Tamsulosin 0.4 mg versus 0.8 mg in management of lower urinary tract symptoms due to benign prostatic enlargement. Int Urol Nephrol. 2024 Jun;56(6):1811-1816. doi: 10.1007/s11255-023-03912-7. Epub 2024 Jan 14.

  PMID: 38219259 BACKGROUND

Related Links

• RCT about similar topic

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

silodosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: February 15, 2026
• First Posted: September 11, 2026
• Study Start: October 12, 2025
• Primary Completion: October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)