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The main objective of this prospective randomized controlled study is to compare safety and efficacy of Vardenafil versus Tadalafil versus Tamsulosin in terms of (voiding function, sexual function and quality of life) in the management of moderate BPH related LUTS.
This is prospective randomized controlled study that will be conducted on men with BPH related LUTS amenable to medical treatment at Urology Department, Faculty of Medicine, Tanta University - Egypt after having their written informed consent.
The study is planned to include 150 patients in the study period from April 2024 to April 2025. Each enrolled patient must complete 12 weeks on medication with strict scheduled follow up.
Inclusion criteria:
Sexually active patients with moderate BPH related LUTS amenable to medical treatment and completed 12 weeks follow up period.
Exclusion criteria:
Indication for combined therapy in patients who have moderate to severe LUTS and an increased risk of disease progression (e.g. prostate volume more than 40 ml) or patients in need for anti-muscarinic for predominant storage symptoms.
Indication for surgical intervention:
Medically complicated patients:
Cardiac patients, unstable angina, recent myocardial infarction (<3months), hypotension.
Concomitant uses (potassium channel openers, alpha 1 blockers, nitrates). Stroke since less than 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vardenafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia | Experimental | 50 patients will take Vardenafil 5 mg tabs twice daily and will be assessed at 4th week and 12th week. Treatment efficacy will be assessed by a change in pre and post treatment Q-max, PVR (post void residual urine), IPSS, (International Prostate Symptom Score) and Sexual Health Inventory for Men (SHIM) with monitoring any side effects |
|
| Tadalafil in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia | Active Comparator | 50 patients will take Tadalafil 5 mg tabs once daily and will be assessed at 4th week and 12th week. Treatment efficacy will be assessed by a change in pre and post treatment Q-max, PVR (post void residual urine), IPSS, (International Prostate Symptom Score) and Sexual Health Inventory for Men (SHIM) with monitoring any side effects |
|
| Tamsulosin in patients with lower urinary tract symptoms secondary to benign prostatic hyperplasia | Active Comparator | 50 patients will take Tamsulosin 0.4 mg tabs once daily and will be assessed at 4th week and 12th week. Treatment efficacy will be assessed by a change in pre and post treatment Q-max, PVR (post void residual urine), IPSS, (International Prostate Symptom Score) and Sexual Health Inventory for Men (SHIM) with monitoring any side effects |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vardenafil 5 Mg Oral Tablet | Drug | Comparing safety and efficacy of Vardenafil 5 mg twice oral daily versus established drugs e.g.Tadalafil 5mg and Tamsulosin 0.4 mg once oral daily in terms of (voiding function, sexual function and quality of life) in the management of moderate BPH related LUTS (benign prostatic hyperplasia related lower urinary tract syptoms ) |
| Measure | Description | Time Frame |
|---|---|---|
| International prostate symptom score (IPSS total score) | Change in pre and post treatment condition (IPSS : international prostate symptom score - decresing in the score equals improving the symptoms ) | 3 months |
| The maximum urinary flow rate (Q-max) | Change in pre and post treatment condition (increasing at Q-max equals improving the symptoms ) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual Health Inventory for Men (SHIM) | Change in pre and post treatment condition (SHIM: Sexual Health Inventory for Men - increasing in the score equals improving the symptoms ) | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
male gender
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hazem B. Baz, M.B.B.Ch | Contact | 00201020337967 | hazem30839637@med.tanta.edu.eg | |
| Mohamed G. Soliman, M.D | Contact | 00201018362537 | mohamed.soliman@med.tanta.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Hazem B. Baz, M.B.B.Ch | Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculity of medicine - Tanta university | Recruiting | Tanta | Gharbia Governorate | 31528 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32012409 | Background | Nagasubramanian S, John NT, Antonisamy B, Mukha RP, Jeyachandra Berry CS, Kumar S, Devasia A, Kekre NS. Tamsulosin and placebo vs tamsulosin and tadalafil in male lower urinary tract symptoms: a double-blinded, randomised controlled trial. BJU Int. 2020 May;125(5):718-724. doi: 10.1111/bju.15027. Epub 2020 Feb 27. | |
| 18281145 | Result |
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| ID | Term |
|---|---|
| D000069058 | Vardenafil Dihydrochloride |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Stief CG, Porst H, Neuser D, Beneke M, Ulbrich E. A randomised, placebo-controlled study to assess the efficacy of twice-daily vardenafil in the treatment of lower urinary tract symptoms secondary to benign prostatic hyperplasia. Eur Urol. 2008 Jun;53(6):1236-44. doi: 10.1016/j.eururo.2008.01.075. Epub 2008 Feb 4. |
| D010879 |
| Piperazines |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |