A Trial for Prevention of Recurrent Ischemic Priapism in Men With Sickle Cell Disease: A Pilot Study

Summary

To conduct a randomized controlled internal pilot feasibility trial for the prevention of recurrent ischemic priapism referred to as the Priapism in Nigeria (PIN) trial. The study team will enroll a minimum of 30 participants and a maximum of 200 participants. Study investigators hypothesize that hydroxyurea therapy combined with tadalafil is superior to a combination of hydroxyurea and placebo in the prevention of recurrent ischemic priapism.

Timeline

Start

2022-04-01

Primary completion

2023-07-10

Completion

2023-11-09

Publications

• Background Piel FB, Hay SI, Gupta S, Weatherall DJ, Williams TN. Global burden of sickle cell anaemia in children under five, 2010-2050: modelling based on demographics, excess mortality, and interventions. PLoS Med. 2013;10(7):e1001484. doi: 10.1371/journal.pmed.1001484. Epub 2013 Jul 16.
• Background Anele UA, Morrison BF, Burnett AL. Molecular pathophysiology of priapism: emerging targets. Curr Drug Targets. 2015;16(5):474-83. doi: 10.2174/1389450115666141111111842.
• Background Huang AW, Muneyyirci-Delale O. Reproductive endocrine issues in men with sickle cell anemia. Andrology. 2017 Jul;5(4):679-690. doi: 10.1111/andr.12370. Epub 2017 Jun 29.
• Background Adeyoju AB, Olujohungbe AB, Morris J, Yardumian A, Bareford D, Akenova A, Akinyanju O, Cinkotai K, O'Reilly PH. Priapism in sickle-cell disease; incidence, risk factors and complications - an international multicentre study. BJU Int. 2002 Dec;90(9):898-902. doi: 10.1046/j.1464-410x.2002.03022.x.
• Background Emond AM, Holman R, Hayes RJ, Serjeant GR. Priapism and impotence in homozygous sickle cell disease. Arch Intern Med. 1980 Nov;140(11):1434-7.
• Background Serjeant G, Hambleton I. Priapism in Homozygous Sickle Cell Disease: A 40-year Study of the Natural History. West Indian Med J. 2015 Jun;64(3):175-80. doi: 10.7727/wimj.2014.119. Epub 2015 Apr 27.
• Background Virag R, Bachir D, Lee K, Galacteros F. Preventive treatment of priapism in sickle cell disease with oral and self-administered intracavernous injection of etilefrine. Urology. 1996 May;47(5):777-81; discussion 781. doi: 10.1016/s0090-4295(96)00027-1.
• Background Okpala I, Westerdale N, Jegede T, Cheung B. Etilefrine for the prevention of priapism in adult sickle cell disease. Br J Haematol. 2002 Sep;118(3):918-21. doi: 10.1046/j.1365-2141.2002.03691.x.
• Background Olujohungbe AB, Adeyoju A, Yardumian A, Akinyanju O, Morris J, Westerdale N, Akenova Y, Kehinde MO, Anie K, Howard J, Brooks A, Davis VA, Khoriatry AI. A prospective diary study of stuttering priapism in adolescents and young men with sickle cell anemia: report of an international randomized control trial--the priapism in sickle cell study. J Androl. 2011 Jul-Aug;32(4):375-82. doi: 10.2164/jandrol.110.010934. Epub 2010 Dec 2.
• Background Rachid-Filho D, Cavalcanti AG, Favorito LA, Costa WS, Sampaio FJ. Treatment of recurrent priapism in sickle cell anemia with finasteride: a new approach. Urology. 2009 Nov;74(5):1054-7. doi: 10.1016/j.urology.2009.04.071. Epub 2009 Jul 17.
• Background Abern MR, Levine LA. Ketoconazole and prednisone to prevent recurrent ischemic priapism. J Urol. 2009 Oct;182(4):1401-6. doi: 10.1016/j.juro.2009.06.040. Epub 2009 Aug 15.
• Background DeCastro BJ, Costabile RA, McMann LP, Peterson AC. Oral ketoconazole for prevention of postoperative penile erection: a placebo controlled, randomized, double-blind trial. J Urol. 2008 May;179(5):1930-2. doi: 10.1016/j.juro.2008.01.039. Epub 2008 Mar 18.
• Background Saad ST, Lajolo C, Gilli S, Marques Junior JF, Lima CS, Costa FF, Arruda VR. Follow-up of sickle cell disease patients with priapism treated by hydroxyurea. Am J Hematol. 2004 Sep;77(1):45-9. doi: 10.1002/ajh.20142.
• Background Burnett AL, Bivalacqua TJ, Champion HC, Musicki B. Feasibility of the use of phosphodiesterase type 5 inhibitors in a pharmacologic prevention program for recurrent priapism. J Sex Med. 2006 Nov;3(6):1077-1084. doi: 10.1111/j.1743-6109.2006.00333.x.
• Idris IM, Yusuf AA, Ismail II, Borodo AM, Hikima MS, Kana SA, Aliyu T, Musangedu K, Jibrilla AU, Aji SA, Kuliya-Gwarzo A, Mohammad K, Galadanci JA, Alkassim R, Suwaid MA, Hussaini N, Rodeghier M, Burnett AL, DeBaun MR. A controlled trial for preventing priapism in sickle cell anemia: hydroxyurea plus placebo vs hydroxyurea plus tadalafil. Blood. 2025 Jun 26;145(26):3101-3112. doi: 10.1182/blood.2024027898.

Drugs

Indications