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Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07815379
Enrollment
140
Registered
2026-09-11
Start date
2025-10-12
Completion date
2026-11-01
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BPH (Benign Prostatic Hyperplasia)

Keywords

BPH, alpha blockers, LUTS

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.

Interventions

DRUGalpha 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.

DRUGalpha blockers Tamsulosin and Silodosin

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

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
40 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
IPSS change3 monthsIPSS score change at 1 and 3 months following drug adminstration

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026