Benign Prostatic Hyperplasia, Erectile Dysfunction, Lower Urinary Tract Symptoms
Conditions
Keywords
Benign Prostatic Hyperplasia, BPH, Lower Urinary Tract Symptoms, LUTS, Tadalafil, Tamsulosin, 5-Alpha Reductase Inhibitors, 5ARI, Finasteride, Dutasteride, Phosphodiesterase-5 Inhibitors, PDE5 Inhibitors, Erectile Function, Ejaculatory Dysfunction, IPSS, Randomized Controlled Trial, Urology
Brief summary
Benign prostatic hyperplasia (BPH) is a common condition among aging men that causes lower urinary tract symptoms (LUTS) and may negatively affect sexual function. This randomized single-blind controlled clinical trial compares the efficacy, safety, and sexual outcomes of different dosing regimens of tadalafil or tamsulosin combined with 5-alpha reductase inhibitors (5ARIs) in men with BPH and enlarged prostate volume. A total of 240 participants were randomly assigned to six treatment groups and followed for 12 weeks. Changes in urinary symptoms, erectile function, ejaculatory function, prostate volume, prostate-specific antigen (PSA), urinary flow rate, post-void residual volume, and adverse events were evaluated to determine the optimal combination regimen.
Detailed description
Benign prostatic hyperplasia (BPH) is one of the most common causes of lower urinary tract symptoms (LUTS) in older men and is frequently associated with impaired sexual function. Alpha-blockers and 5-alpha reductase inhibitors (5ARIs) are widely used for medical management; however, both treatment strategies may adversely affect sexual function. Phosphodiesterase type-5 inhibitors, particularly tadalafil, have emerged as an alternative therapeutic option because they improve LUTS while preserving erectile function. This randomized, single-blind, controlled clinical trial was conducted at the Department of Urology, Faculty of Medicine, Beni-Suef University, Egypt. The study enrolled 240 eligible men aged 50 years or older with moderate-to-severe LUTS secondary to BPH and prostate volume greater than 40 mL. Participants were randomly allocated into six equal treatment groups comparing different dosing regimens of tadalafil or tamsulosin combined with 5-alpha reductase inhibitors. The primary objective was to compare improvements in lower urinary tract symptoms using the International Prostate Symptom Score (IPSS). Secondary objectives included evaluation of erectile function using the International Index of Erectile Function-Erectile Function domain (IIEF-EF), ejaculatory function using the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD), maximum urinary flow rate (Qmax), prostate volume, prostate-specific antigen (PSA), post-void residual urine volume (PVR), and treatment-related adverse events. Participants received treatment for 12 weeks and were assessed at baseline and at the end of the study. Safety was evaluated by monitoring adverse events throughout the study. The findings are expected to identify the most effective and well-tolerated combination regimen for improving both urinary and sexual outcomes in men with benign prostatic hyperplasia.
Interventions
DRUGTamsulosin
Tamsulosin hydrochloride 0.4 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.
DRUGTadalafil
Tadalafil 5 mg administered orally either once daily or every other day according to the randomized treatment allocation for 12 weeks.
A 5-alpha reductase inhibitor (finasteride 5 mg or dutasteride 0.5 mg according to routine clinical practice) administered either once daily or every other day according to the randomized treatment allocation for 12 weeks.
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors were blinded to treatment allocation to minimize assessment bias. Participants received one of the six randomized treatment regimens throughout the study.
Intervention model description
Participants were randomly assigned in a 1:1:1:1:1:1 ratio into six parallel treatment groups to compare different dosing regimens of tadalafil or tamsulosin combined with 5-alpha reductase inhibitors. Each participant received only one assigned treatment regimen throughout the 12-week study period.
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male participants aged 50 years or older. * Newly diagnosed with benign prostatic hyperplasia (BPH). * Moderate to severe lower urinary tract symptoms (LUTS), defined as International Prostate Symptom Score (IPSS) \> 7. * Prostate volume \>40 mL confirmed by transrectal ultrasonography (TRUS). * Sexually active with a baseline International Index of Erectile Function-Erectile Function (IIEF-EF) score \>10. * Prostate-specific antigen (PSA) \<4 ng/mL and no suspicious findings on digital rectal examination (DRE). * Able and willing to provide written informed consent.
Exclusion criteria
* History of prostate cancer. * Previous prostate surgery. * Abnormal digital rectal examination suggestive of malignancy. * Severe erectile dysfunction (IIEF-EF score ≤10). * Uncontrolled diabetes mellitus. * Uncontrolled cardiovascular disease. * Neurological disorders affecting bladder function. * Renal impairment. * Hepatic impairment. * Active urinary tract infection. * Bladder stones or other significant urological pathology. * Known hypersensitivity to tamsulosin, tadalafil, or 5-alpha reductase inhibitors. * Patients actively seeking fertility treatment. * Current use of medications known to significantly affect sexual function. * Concurrent use of nitrates or contraindicated antihypertensive medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lower Urinary Tract Symptoms (IPSS) | Baseline and Week 12 | Change in the International Prostate Symptom Score (IPSS) from baseline to Week 12. Higher scores indicate more severe symptoms; a reduction in score reflects clinical improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Erectile Function | Baseline and Week 12 | Change in the International Index of Erectile Function-Erectile Function domain (IIEF-EF) score from baseline to Week 12. Higher scores indicate better erectile function. |
| Change in Ejaculatory Function | Baseline and Week 12 | Change in the Male Sexual Health Questionnaire-Ejaculatory Dysfunction (MSHQ-EjD) score from baseline to Week 12. |
| Change in Maximum Urinary Flow Rate (Qmax) | Baseline and Week 12 | Change in maximum urinary flow rate measured by uroflowmetry from baseline to Week 12. |
| Change in Prostate Volume | Baseline and Week 12 | Change in prostate volume measured by transrectal ultrasonography (TRUS) from baseline to Week 12. |
| Change in Prostate-Specific Antigen (PSA) | Baseline and Week 12 | Change in serum prostate-specific antigen (PSA) level from baseline to Week 12. |
| Change in Post-Void Residual Volume (PVR) | Baseline and Week 12 | Change in post-void residual urine volume measured by bladder ultrasound from baseline to Week 12. |
| Incidence of Treatment-Related Adverse Events | Throughout the 12-week treatment period | Frequency and type of treatment-emergent adverse events, including dizziness, orthostatic hypotension, headache, flushing, dyspepsia, gynecomastia, decreased libido, erectile dysfunction, and ejaculatory dysfunction. |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATOROmar S Taha, MBBCh
Department of Urology, Faculty of Medicine, Beni-Suef University
Outcome results
None listed