European Journal of Cardiovascular Medicine

malignant enlargement of the prostate gland that affects aging men and is frequently associated with bothersome lower urinary tract symptoms (LUTS) such as urinary frequency, urgency, nocturia, and a weak urinary stream (1). The prevalence of BPH increases with age, with histological evidence found in approximately 50% of men aged 60 years and up to 90% of men aged 85 years (2). These symptoms significantly impair the quality of life and may lead to complications such as urinary retention and the need for surgical intervention if left untreated (3).

Pharmacological management of BPH commonly involves the use of alpha-1 adrenergic receptor blockers (α1-blockers) like tamsulosin, which act by relaxing the smooth muscle of the prostate and bladder neck, thereby improving urinary flow and reducing symptom severity (4). However, α1-blockers do not reduce prostate size or prevent disease progression. Finasteride, a 5-alpha-reductase inhibitor (5-ARI), targets the underlying pathology by inhibiting the conversion of testosterone to dihydrotestosterone (DHT), resulting in gradual prostate shrinkage and reduction in symptom progression and complications (5).

Several studies have suggested that combination therapy using both α1-blockers and 5-ARIs may provide superior symptom relief and long-term benefits compared to monotherapy, particularly in men with larger prostate volumes and higher symptom scores (6,7). The Medical Therapy of Prostatic Symptoms (MTOPS) trial and the Combination of Avodart and Tamsulosin (CombAT) study provided foundational evidence supporting the synergistic efficacy of combination therapy in reducing the risk of BPH progression and improving clinical outcomes (8,9).

This study aims to evaluate the impact of combination therapy with tamsulosin and finasteride on LUTS in BPH patients, focusing on symptom score improvement, urinary flow rate, and post-void residual urine compared to tamsulosin monotherapy in a randomized controlled setting.

A total of 120 male patients aged between 50 and 80 years, diagnosed with symptomatic benign prostatic hyperplasia (BPH), were enrolled based on predefined inclusion and exclusion criteria. Inclusion criteria included an International Prostate Symptom Score (IPSS) of ≥8, prostate volume ≥30 mL confirmed via transrectal ultrasonography, and maximum urinary flow rate (Qmax) between 5–15 mL/s. Patients with prostate cancer, urinary tract infection, previous prostate surgery, neurogenic bladder, or those currently on BPH medications were excluded.

Randomization and Group Allocation:
Eligible participants were randomly allocated into two groups (n=60 each) using a computer-generated random number table. Group A received tamsulosin 0.4 mg once daily, while Group B received a combination of tamsulosin 0.4 mg and finasteride 5 mg once daily. Both medications were administered orally after meals.

Blinding:
Both patients and investigators were blinded to group assignments. Identical-appearing capsules were used to maintain blinding integrity throughout the study.

Outcome Measures:
The primary outcome measure was the change in IPSS from baseline to 6 and 12 months. Secondary outcomes included changes in maximum urinary flow rate (Qmax) measured by uroflowmetry and post-void residual urine (PVR) measured via ultrasound at the same intervals. Adverse effects were also recorded throughout the study period.

Statistical Analysis:
Data were analyzed using SPSS version 26. Descriptive statistics were expressed as mean ± standard deviation (SD) for continuous variables. Within-group comparisons were made using paired t-tests, and between-group differences were assessed using independent t-tests and ANOVA, with a significance level set at p<0.05.

This methodological approach allowed for a comprehensive evaluation of the comparative effectiveness of monotherapy and combination therapy in managing LUTS due to BPH.

A total of 120 patients completed the 12-month follow-up period without major protocol deviations. Both groups were comparable at baseline with respect to age, prostate volume, IPSS, Qmax, and PVR (Table 1). The mean age in Group A (tamsulosin only) was 66.4 ± 5.7 years, and in Group B (combination therapy) was 67.1 ± 6.1 years. Mean prostate volume was 42.5 ± 6.8 mL in Group A and 43.2 ± 7.1 mL in Group B.

Symptom Score (IPSS):
At baseline, mean IPSS was 21.2 ± 3.5 in Group A and 21.5 ± 3.8 in Group B. After 12 months, Group A showed a significant reduction to 13.1 ± 2.9, while Group B showed a greater reduction to 9.4 ± 2.5 (p<0.01) (Table 2).

Maximum Urinary Flow Rate (Qmax):
Baseline Qmax was 10.1 ± 1.6 mL/s in Group A and 9.8 ± 1.7 mL/s in Group B. At 12 months, Qmax improved to 13.8 ± 2.1 mL/s in Group A and to 16.2 ± 2.4 mL/s in Group B (p=0.03) (Table 2).

Post-Void Residual Urine (PVR):
Initial PVR values were 83.7 ± 19.5 mL in Group A and 85.1 ± 20.2 mL in Group B. At the end of the study, Group A showed a reduction to 53.2 ± 16.4 mL, whereas Group B showed a more significant reduction to 38.6 ± 14.3 mL (p=0.04) (Table 2).

Adverse Effects:
No serious adverse events were reported. Mild side effects such as dizziness (5% in Group A, 8% in Group B) and decreased libido (0% in Group A, 10% in Group B) were noted but did not lead to discontinuation.

Table 1: Baseline Characteristics of Study Participants

Table 2: Clinical Outcomes at 12 Months

These results indicate that combination therapy provided superior improvement in symptom severity, urinary flow rate, and bladder emptying compared to monotherapy (Tables 1 and 2).

The present randomized controlled trial demonstrates that combination therapy with tamsulosin and finasteride significantly improves lower urinary tract symptoms (LUTS), urinary flow rates, and post-void residual urine volumes in men with benign prostatic hyperplasia (BPH), compared to tamsulosin monotherapy. These findings are consistent with previous large-scale trials such as MTOPS and CombAT, which established the long-term benefits of combination therapy over monotherapy (1,2).

Alpha-1 adrenergic receptor antagonists like tamsulosin act rapidly by relaxing prostatic and bladder neck smooth muscle, providing prompt symptomatic relief (3). However, they do not halt disease progression or reduce prostate size. In contrast, 5-alpha-reductase inhibitors (5-ARIs) such as finasteride inhibit the conversion of testosterone to dihydrotestosterone (DHT), leading to gradual prostate shrinkage and reduced risk of urinary retention and surgical intervention (4,5). The combination of these agents thus offers both rapid symptom control and long-term disease modification.

Our study showed a mean IPSS reduction of 7.9 points in the combination group, which is clinically significant and exceeds the minimum 3-point improvement considered meaningful for patients (6). This improvement aligns with Roehrborn et al., who reported a similar magnitude of IPSS reduction in combination therapy over four years (7). The superior improvement in Qmax and PVR in our combination group further supports the functional advantages of dual therapy, as observed in prior studies (8,9).

The reduction in PVR noted in our study (to 38.6 mL in the combination group) is indicative of improved bladder emptying and may contribute to decreased nocturia and urgency episodes—common complaints among BPH patients (10). Such reductions in bladder outlet obstruction parameters could potentially delay or eliminate the need for surgical intervention in appropriately selected patients (11).

While the adverse effect profile of combination therapy included mild sexual dysfunction, such as decreased libido in 10% of patients, the overall safety profile remained acceptable, as previously documented in long-term trials (12,13). Importantly, none of the patients discontinued therapy due to adverse events, suggesting high tolerability in real-world settings.

The selection of patients with prostate volumes ≥30 mL and moderate to severe LUTS was crucial, as these individuals are most likely to benefit from finasteride therapy (14,15). This emphasizes the need for proper patient stratification before initiating combination therapy to optimize therapeutic outcomes and minimize unnecessary exposure to 5-ARIs in patients unlikely to benefit.

One limitation of this study was the relatively short follow-up duration of 12 months. Although this period is adequate to assess symptom relief and initial urodynamic changes, longer follow-up is required to evaluate long-term effects on disease progression, acute urinary retention, and need for surgery. Additionally, the single-center design may limit generalizability.

Despite these limitations, our findings reinforce the value of combination therapy in appropriately selected BPH patients, especially those with larger prostates and higher symptom burden. Future studies should aim at evaluating cost-effectiveness and patient-reported quality of life outcomes in diverse populations to support broader clinical recommendations.

This randomized controlled trial confirms that combination therapy with tamsulosin and finasteride provides significantly greater improvement in lower urinary tract symptoms, urinary flow rates, and post-void residual urine volumes in patients with benign prostatic hyperplasia, compared to tamsulosin monotherapy. The dual mechanism of action addresses both dynamic and static components of bladder outlet obstruction, offering both rapid symptom relief and long-term disease modification. Combination therapy was well tolerated, with a manageable side effect profile. These findings support the use of combination treatment, particularly in men with larger prostate volumes and more severe baseline symptoms, for optimal clinical outcomes. Long-term follow-up studies are warranted to further validate these benefits and assess their impact on disease progression and surgical intervention rates.

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