Intermittent vs Daily Tamsulosin for LUTS/BPH

NCT07308002 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: ARAB BPH Study
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Lower urinary tract symptoms (LUTS) are common in aging men, most often due to benign prostatic hyperplasia (BPH), and significantly impair quality of life. α1-adrenoceptor antagonists are first-line therapy, with tamsulosin being the most widely prescribed. However, ejaculatory dysfunction (EjD) is a frequent adverse effect that negatively affects adherence. Optimal dosing strategies that maintain urinary efficacy while reducing EjD are not well defined, and current guidelines provide no recommendations regarding alternate-day dosing. Patients and Methods: This multicenter, randomized, open-label, assessor-blinded, parallel-group, non-inferiority trial will enroll men aged ≥50 years with LUTS/BPH and baseline IPSS ≥8. Participants will be randomized 1:1 to receive tamsulosin 0.4 mg once daily or every other day for 24 weeks. The primary endpoint is change in International Prostate Symptom Score (IPSS) from baseline to Week 24. Non-inferiority will be concluded if the upper bound of the two-sided 95% confidence interval (CI) for the between-group difference in mean IPSS change (EOD - Daily) is ≤ +3 points. The key secondary endpoint is change in Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD) total score from baseline to Week 24, tested for superiority only if IPSS non-inferiority is established. Additional secondary endpoints include maximum urinary flow rate (Qmax), post-void residual volume (PVR), IPSS-Quality of Life score, and ejaculatory adverse-event rates. Sample Size and Analysis: Assuming an SD of 6 for IPSS change, a non-inferiority margin of +3, one-sided α of 0.025, and 90% power, approximately 85 evaluable patients per arm are required for the primary endpoint. To ensure adequate power for EjD outcomes and allow for 20% attrition, 144 participants per arm (288 total) will be randomized. Analyses will follow the intention-to-treat principle with per-protocol sensitivity analyses. Primary inference will use ANCOVA or MMRM adjusted for baseline score, age, and study site, with multiple imputation for missing data. Expected Outcomes: This trial will provide the first adequately powered multicenter evidence on whether every-other-day tamsulosin preserves non-inferior LUTS control while improving ejaculatory outcomes, potentially supporting a simple and cost-effective strategy to enhance tolerability and adherence in men with LUTS/BPH.

Conditions

Lower Urinary Tract Symptoms; Prostate Obstruction

Keywords

Lower Urinary Tract Symptoms; Tamsulosin; Benign prostatic obstruction; Alternate-Day Dosing; Ejaculatory Dysfunction

Outcome Measures

Primary Outcomes (1)

• Change in International prostate symptom score (IPSS) From Baseline to Week 24

  Change in the International Prostate Symptom Score (IPSS) from baseline to Week 24. The IPSS is a validated 7-item questionnaire assessing lower urinary tract symptoms, with total scores ranging from 0 to 35, where higher scores indicate more severe symptoms. This is a non-inferiority comparison with a non-inferiority margin of +3 IPSS points. Non-inferiority will be concluded if the upper bound of the two-sided 95% confidence interval for the between-group difference in mean IPSS change (Intermittent - Daily) is ≤ +3 points.

  Baseline to Week 24

Secondary Outcomes (1)

• Change in MSHQ-Ejaculatory Dysfunction Total Score From Baseline to Week 24

  Baseline to Week 24

Study Arms (2)

Daily arm: Tamsulosin 0.4 mg once daily.

ACTIVE COMPARATOR

Drug: Daily Tamsulosin

EOD arm: Tamsulosin 0.4 mg every other day (no capsule on off-days)

EXPERIMENTAL

Drug: Intermittent Tamsulosin

Interventions

Intermittent Tamsulosin DRUG

Participants receive tamsulosin 0.4 mg every other day (intermittent regimen) for the study duration. The regimen is designed to evaluate whether reduced-frequency dosing is non-inferior to standard daily therapy in improving LUTS/BPH symptoms.

EOD arm: Tamsulosin 0.4 mg every other day (no capsule on off-days)

Daily Tamsulosin DRUG

Participants receive standard tamsulosin 0.4 mg once daily for the study duration. This arm serves as the reference for evaluating efficacy and safety compared with the intermittent regimen.

Daily arm: Tamsulosin 0.4 mg once daily.

Eligibility Criteria

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

You may qualify if:

• Men ≥40 years with LUTS/BPH.
• IPSS ≥8, Qmax 5-15 mL/s (voided volume ≥150 mL), PVR \<200 mL.
• Sexually active within the past month (for ejaculatory outcomes).
• BPH-treatment naïve: no prior use of antimuscarinics or 5-α-reductase inhibitors (5-ARIs) and agrees not to initiate these agents during the trial.

You may not qualify if:

• PVR ≥ 200 mL.
• Prior prostate/ radical pelvic surgery (that affect pelvic innervation).
• Neurogenic bladder (atonic/ hypotonic bladder).
• Severe hepatic/renal insufficiency.
• Significant cardiovascular or cerebrovascular disease.
• Any indication of surgical treatment (vesical stones, chronic urine retention, recurrent attacks of acute urine retention, recurrent attacks of gross hematuria, hydronephrosis)

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and nephrology center

Al Mansurah, Outside U.S./Canada, 35516, Egypt

Location

MeSH Terms

Conditions

Lower Urinary Tract Symptoms; Ejaculatory Dysfunction

Condition Hierarchy (Ancestors)

Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases

Central Study Contacts

Mahmoud AN Laymon, Mahmoud

CONTACT

066053151; dr_mahmoudlaymon@mans.edu.eg

Ahmed Shokeir

CONTACT

ahmed.shokeir@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: After allocation, both investigators and participants will be aware of the assigned dosing regimen (open-label). To minimize bias, all efficacy assessments (e.g., IPSS, uroflowmetry, and PVR) will be conducted by trained assessors who are blinded to treatment allocation and not involved in clinical management or drug dispensing. Study statisticians will remain blinded to treatment identity until the database is locked and the primary analysis completed. Any instance of unintentional unblinding will be documented, along with its rationale and potential impact on the study outcome.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: December 29, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)