Benign Prostatic Hyperplasia, Efficacy, Lower Urinary Tract Symptoms, Monotherapy, Safety, Tadalafil, Tamsulosin
Conditions
Brief summary
This study aims to evaluate the short-term impact and clinical outcomes of tamsulosin monotherapy versus combination therapy with tamsulosin plus tadalafil (2.5 mg vs. 5 mg) on lower urinary tract symptoms (LUTS) severity and patient quality of life in men with benign prostatic hyperplasia (BPH). It also seeks to determine whether the lower tadalafil dose provides adequate symptom relief while minimizing adverse effects over a 12-week follow-up period.
Detailed description
Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) are a fundamental component of modern urology, affecting extensively aging men and significantly impacting their quality of life. Tamsulosin monotherapy, is effective in the management of BPH by acting as an α₁-adrenergic receptor antagonist that relaxes smooth muscle in the prostate and bladder neck, thereby improving urinary flow and reducing LUTS. The combination of tamsulosin 0.4 mg with tadalafil is commonly used as an effective option. It balances sufficient symptom relief with moderate side effect profile.
Interventions
DRUGTamsulosin 0.4 mg + Tadalafil 2.5 mg
Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 2.5 mg once daily
DRUGTamsulosin 0.4 mg + Tadalafil 5 mg
Patients will receive Tamsulosin 0.4 mg once daily + Tadalafil 5 mg once daily
Patients will receive Tamsulosin 0.4 mg once daily (monotherapy)
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 45 years of age. * Clinical diagnosis of benign prostatic hyperplasia (BPH) and moderate to severe lower urinary tract symptoms (LUTS) \[International Prostate Symptom Score (IPSS) ≥ 13\]. * Maximum flow rate (Qmax) ≤ 15 mL/s, prostate volume ≥ 30 mL by transrectal ultrasound.
Exclusion criteria
* Patients taking α-blockers, beta-blockers, 5-alpha reductase inhibitors, phosphodiesterase-5 (PDE5) inhibitors, anticholinergics, or nitrates were excluded. * Patients with a history of prostate or bladder surgery, lower urinary tract procedures, prostate or bladder cancer, neurological conditions affecting bladder function, severe cardiovascular disease, hepatic impairment, diabetes mellitus with complications, kidney dysfunction (acute or chronic), neurogenic bladder, or congenital urinary anomalies. * Additionally, patients with recent myocardial infarction, unstable angina, severe heart failure, uncontrolled hypertension, Prostate-Specific Antigen (PSA)\>4 ng/mL (unless cancer ruled out), active urinary tract infection, urinary retention, and those unavailable for follow-up were also excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in International Prostate Symptom Score (IPSS) score | 12 weeks post-procedure | The International Prostate Symptom Score (IPSS) is an 8-question survey used to evaluate and track the severity of lower urinary tract symptoms, often linked to an enlarged prostate (BPH). Scores range from 0 to 35 based on symptom frequency, with a higher number indicating greater severity. The score evaluates symptoms into the following categories: 0 to 7 points: Mild symptoms 8 to 19 points: Moderate symptoms 20 to 35 points: Severe symptoms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 12 weeks post-procedure | Incidence of adverse events related to Tamsulosin such as dizziness, orthostatic hypotension, headache, fatigue, nasal congestion, retrograde ejaculation, and gastrointestinal disturbances will be recorded. |
Countries
Egypt
Contacts
CONTACTSalah N Salem, MBBCH
Outcome results
None listed