drugset / Trial / NCT04420533
Comparative Study Between Behavior Therapy and Behavior Therapy Plus Mirabegron in Sexually Active Men With OAB Symptoms
RandomizedParallel-groupOpen-labelTreatment
Summary
The objective of this study is to evaluate and compare the therapeutic effects on OAB symptoms, and sexual functions, in terms of erectile function and ejaculatory function, in sexually active OAB male treated with behavior therapy or behavior therapy plus Mirabegron (50 mg).
Timeline
- Start
- 2020-06-05
- Primary completion
- 2022-05-31
- Completion
- 2022-08-31
Publications
- Background Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
- Background Chuang YC, Liu SP, Lee KS, Liao L, Wang J, Yoo TK, Chu R, Sumarsono B. Prevalence of overactive bladder in China, Taiwan and South Korea: Results from a cross-sectional, population-based study. Low Urin Tract Symptoms. 2019 Jan;11(1):48-55. doi: 10.1111/luts.12193. Epub 2017 Oct 2.
- Background Irwin DE, Milsom I, Reilly K, Hunskaar S, Kopp Z, Herschorn S, Coyne KS, Kelleher CJ, Artibani W, Abrams P. Overactive bladder is associated with erectile dysfunction and reduced sexual quality of life in men. J Sex Med. 2008 Dec;5(12):2904-10. doi: 10.1111/j.1743-6109.2008.01000.x.
- Background Coyne KS, Sexton CC, Thompson C, Kopp ZS, Milsom I, Kaplan SA. The impact of OAB on sexual health in men and women: results from EpiLUTS. J Sex Med. 2011 Jun;8(6):1603-15. doi: 10.1111/j.1743-6109.2011.02250.x. Epub 2011 Apr 14.
- Background Yamaguchi O, Chapple CR. Beta3-adrenoceptors in urinary bladder. Neurourol Urodyn. 2007;26(6):752-6. doi: 10.1002/nau.20420.
- Background Cirino G, Sorrentino R, di Villa Bianca Rd, Popolo A, Palmieri A, Imbimbo C, Fusco F, Longo N, Tajana G, Ignarro LJ, Mirone V. Involvement of beta 3-adrenergic receptor activation via cyclic GMP- but not NO-dependent mechanisms in human corpus cavernosum function. Proc Natl Acad Sci U S A. 2003 Apr 29;100(9):5531-6. doi: 10.1073/pnas.0931347100. Epub 2003 Apr 21.
- Background Gur S, Peak T, Yafi FA, Kadowitz PJ, Sikka SC, Hellstrom WJ. Mirabegron causes relaxation of human and rat corpus cavernosum: could it be a potential therapy for erectile dysfunction? BJU Int. 2016 Sep;118(3):464-74. doi: 10.1111/bju.13515. Epub 2016 May 26.
- Background Yilmaz-Oral D, Kaya-Sezginer E, Askin D, Hamurtekin Y, Gur S. Mirabegron, A Selective beta3-Adrenoceptor Agonist Causes an Improvement in Erectile Dysfunction in Diabetic Rats. Exp Clin Endocrinol Diabetes. 2021 Mar;129(4):296-302. doi: 10.1055/a-0869-7493. Epub 2019 Apr 12.
- Background Wu TH, Shen YC, Lee WC, Wang HJ, Chuang YC. Effect of mirabegron on erectile function in sexually active men with bothersome overactive bladder symptoms. J Chin Med Assoc. 2020 Jan;83(1):55-59. doi: 10.1097/JCMA.0000000000000208.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mirabegron | Other / unclassified | 50 mg | Oral |