drugset / Trial / NCT06491108
Medications for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
RandomizedParallel-groupSingle-blindTreatment
Summary
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.
Timeline
- Start
- 2024-06-01
- Primary completion
- 2025-07-01
- Completion
- 2025-07-01
Outcome
Mixed primary results
paper there was a significant improvement in the IPSS total score in the vardenafil group compared with placebo (-5.9 and -3.6, respectively; p=0.0013). PMID 18281145 ↗
paper Qmax and PVR urine volume did not change significantly with treatment, although baseline values were already considered close to normal. PMID 18281145 ↗
Publications
- 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vardenafil | Small molecule | 5 mg | Oral |