drugset / Trial / NCT05537272
The Efficacy of Tamsulosin and Tadalafil Compared to Placebo in the Treatment and Prevention of Urinary Disorders After Transperineal Prostate Biopsy
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to evaluate the therapeutic efficacy of tamsulosin and tadalafil compared to placebo in the treatment and prevention of urinary disorders after transperineal prostate biopsy
Timeline
- Start
- 2022-09-01
- Primary completion
- 2023-09-01
- Completion
- 2023-09-01
Publications
- Results Sefik E, Eker A, Gunlusoy B, Celik S, Bozkurt IH, Basmaci I, Polat S, Degirmenci T, Ceylan Y. The effect of alpha blocker treatment prior to prostate biopsy on voiding functions, pain scores and health-related quality-of-life outcomes: A prospective randomized trial. Prog Urol. 2020 Mar;30(4):198-204. doi: 10.1016/j.purol.2019.12.006. Epub 2020 Jan 23.
- Results Efesoy O, Saylam B, Tek M, Bozlu M, Akbay E. Is there any priority between the alpha blockers on voiding functions after transrectal ultrasound guided prostate biopsy? Turk J Urol. 2021 Mar;47(2):137-143. doi: 10.5152/tud.2021.20509. Epub 2021 Mar 1.
- Results Chung SJ, Jung SI, Ryu JW, Hwang EC, Kwon DD, Park K, Kim JW. The preventive effect of tamsulosin on voiding dysfunction after prostate biopsy: a prospective, open-label, observational study. Int Urol Nephrol. 2015 May;47(5):711-5. doi: 10.1007/s11255-015-0955-7. Epub 2015 Mar 27.
- Results Porst H, Oelke M, Goldfischer ER, Cox D, Watts S, Dey D, Viktrup L. Efficacy and safety of tadalafil 5 mg once daily for lower urinary tract symptoms suggestive of benign prostatic hyperplasia: subgroup analyses of pooled data from 4 multinational, randomized, placebo-controlled clinical studies. Urology. 2013 Sep;82(3):667-73. doi: 10.1016/j.urology.2013.05.005. Epub 2013 Jul 19.
- Results Dong Y, Hao L, Shi Z, Wang G, Zhang Z, Han C. Efficacy and safety of tadalafil monotherapy for lower urinary tract symptoms secondary to benign prostatic hyperplasia: a meta-analysis. Urol Int. 2013;91(1):10-8. doi: 10.1159/000351405. Epub 2013 Jun 25.
- Results Zisman A, Leibovici D, Kleinmann J, Cooper A, Siegel Y, Lindner A. The impact of prostate biopsy on patient well-being: a prospective study of voiding impairment. J Urol. 2001 Dec;166(6):2242-6.
- Results Bozlu M, Ulusoy E, Doruk E, Cayan S, Canpolat B, Schellhammer PF, Akbay E. Voiding impairment after prostate biopsy: does tamsulosin treatment before biopsy decrease this morbidity? Urology. 2003 Dec;62(6):1050-3. doi: 10.1016/j.urology.2003.07.006.
- Results Murray KS, Bailey J, Zuk K, Lopez-Corona E, Thrasher JB. A prospective study of erectile function after transrectal ultrasonography-guided prostate biopsy. BJU Int. 2015 Aug;116(2):190-5. doi: 10.1111/bju.13002. Epub 2015 Mar 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Tadalafil | Small molecule | 5 mg | — |
| Comparator | Tamsulosin | Other / unclassified | 0.4 mg | Oral |