drugset / Trial / NCT05236634
(Phosphodiesterase 5 Inhibitors & α-blockers): Single Versus Combined Therapy in Benign Prostatic Hyperplasia
RandomizedParallel-groupOpen-labelTreatment
Summary
To compare between efficacy of phosphodiesterase5 inhibitors (tadalafil 5 mg) and Alpha Blockers (tamsulosin 0.4 mg) monotherapy vs combined therapy in treatment of lower urinary tract symptoms of benign prostatic hyperplasia.
Timeline
- Start
- 2022-05-01
- Primary completion
- 2024-05-01
- Completion
- 2024-06-30
Publications
- Background Singh DV, Mete UK, Mandal AK, Singh SK. A comparative randomized prospective study to evaluate efficacy and safety of combination of tamsulosin and tadalafil vs. tamsulosin or tadalafil alone in patients with lower urinary tract symptoms due to benign prostatic hyperplasia. J Sex Med. 2014 Jan;11(1):187-96. doi: 10.1111/jsm.12357. Epub 2013 Oct 25.
- Background Wang XH, Wang X, Shi MJ, Li S, Liu T, Zhang XH. Systematic review and meta-analysis on phosphodiesterase 5 inhibitors and alpha-adrenoceptor antagonists used alone or combined for treatment of LUTS due to BPH. Asian J Androl. 2015 Nov-Dec;17(6):1022-32. doi: 10.4103/1008-682X.154990.
- Background Mirone V, Sessa A, Giuliano F, Berges R, Kirby M, Moncada I. Current benign prostatic hyperplasia treatment: impact on sexual function and management of related sexual adverse events. Int J Clin Pract. 2011 Sep;65(9):1005-13. doi: 10.1111/j.1742-1241.2011.02731.x. Epub 2011 Jul 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tadalafil | Small molecule | 5 mg | Oral |
| Comparator | Tamsulosin | Other / unclassified | 0.4 mg | Oral |