Comparing medications for urinary symptoms related to enlarged prostate
Vardenafil Versus Tadalafil Versus Tamsulosin in Patients With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Prospective Randomized Study.
This study is testing if three different medications can help men with urinary problems caused by an enlarged prostate feel better and improve their quality of life.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | Male |
| Sponsor | Tanta University Academic / other |
| Locations | 1 site (Tanta, Gharbia Governorate) |
| Trial ID | NCT06491108 on ClinicalTrials.gov |
What this trial studies
This prospective randomized controlled study aims to evaluate the safety and efficacy of Vardenafil, Tadalafil, and Tamsulosin in treating moderate lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH). Conducted at Tanta University in Egypt, the study will enroll 150 sexually active male patients who will undergo a 12-week treatment period with strict follow-up. The primary outcomes will focus on improvements in voiding function, sexual function, and overall quality of life. Participants will be carefully selected based on specific inclusion and exclusion criteria to ensure the validity of the results.
Who should consider this trial
Good fit: Ideal candidates are sexually active men with moderate BPH-related LUTS who are amenable to medical treatment.
Not a fit: Patients with severe LUTS requiring surgical intervention or those with contraindications to the medications being tested may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective medication options for men suffering from urinary symptoms due to BPH, improving their quality of life.
How similar studies have performed: Other studies have explored similar medication comparisons for BPH, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Sexually active patients . 2. ModerateBPH related LUTS ( bengin prostatic hyperplasia related lower urinary tract symtoms ) i.e: (international prostatic symptom score 8 to 19 : the higher score is the worse symptoms ). 3. Patients accepted medical treatment and completed 12 weeks on medical treatment and strict follow up . Exclusion Criteria: 1. Indication for combined therapy as prostate size over 40 gm . 2. Gross hematuria. 3. Refractory urine retention . 4. Bilateral hydro-ureteronephrosis or renal insufficiency secondary to bengin prostatic hyperplasia. 5. Bladder diverticula or calculi . 6. History of bladder or prostate cancer. 7. Unwilling patients to medical therapy. 8. History of pelvic surgery or urethral stricture.
Where this trial is running
Tanta, Gharbia Governorate
- Faculity of medicine - Tanta university — Tanta, Gharbia Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Hazem B. Baz, M.B.B.Ch — Tanta University
- Study coordinator: Hazem B. Baz, M.B.B.Ch
- Email: hazem30839637@med.tanta.edu.eg
- Phone: 00201020337967
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.