A Randomized Controlled Trial Comparing the Efficacy of the Combination Treatment with Tamsulosin Plus Solifenacin and Tamsulosin Alone for Overactive Bladder Related with Benign Prostatic Hyperplasia
Keywords:
Combination Treatment, Tamsulosin, Solifenacin, Overactive Bladder, Benign Prostatic HyperplasiaAbstract
Objective: To compare the efficacy of lower urinary tract symptoms (LUTS) relief in patients who had benign prostatic hyperplasia (BPH) and symptoms of overactive bladder (OAB) taking tamsulosin with placebo and tamsulosin with solifenacin.
Design: Randomized double-blind placebo controlled trial
Setting: King Chulalongkorn Memorial hospital which is a 1,500-bed tertiary care center
Research Methodology: Fifty five patients, mean age 66.6 years with LUTS from BPH and OAB symptoms were randomly allocated into two groups after receiving tamsulosin for 2 weeks. Control group received tamsulosin with placebo (vitamin C). Treatment group received tamsulosin with solifenacin. Both groups had 4 week course of study. Efficacy outcomes were recorded including IPSS score, OAB screener score and Bladder Sensation Scale. Safety and tolerability outcomes were uroflowmetry monitoring and any adverse events.
Results: Patients who receive both tamsulosin and solifenacin (treatment group) were significantly decreased in irritative symptom score and bladder sensation scale (P=0.005, P=0.49 respecticely). No difference in maximum urinary flow rate and residual urine was observed. Adverse events were found in treatment group more common than in control group, especially dry mouth and constipation (P=0.005, P<0.001).
Conclusion: Combination of tamsulosin (adrenergic blockade) and solifenacin (antimuscarinic agent) demonstrated significant reduction of irritative symptoms in BPH patient from IPSS questionnaire and Bladder sensation scale. No difference in maximum flow rate and post-void residual urine in both groups were observed. Adverse events were found in treatment group more often than in control group especially dry mouth and constipation. Although most adverse reactions were mild and tolerable.
References
Roehrborn CG, Abrams P, Rovner ES, Kaplan SA, Herschorn S, Guan Z. Efficacy and tolerability of tolterodine extended-release in men with overactive bladder and urgency urinary incontinence. BJU Int. 2006 May; 97(5): 1003-6.
Schulman CC. Long-term aspects of medical treatment of BPH. Eur Urol. 2001; 40 Suppl3: 8-12.
Speakman MJ, Brading AF, Gilpin CJ, Dixon JS, Gilpin SA, Gosling JA. Bladder outflow obstruction--a cause of denervation supersensitivity. J Urol. 1987 Dec; 138(6): 1461-6.
Coyne KS, Matza LS, Thompson CL, Kopp ZS, Khullar V. Determining the importance of change in the overactive bladder questionnaire. J Urol. 2006 Aug; 176(2): 627-32; discussion 32.
Kaplan SA, Roehrborn CG, Rovner ES, Carlsson M, Bavendam T, Guan Z. Tolterodine and tamsulosin for treatment of men with lower urinary tract symptoms and overactive bladder: a randomized controlled trial. Jama. 2006 Nov 15; 296(19): 2319-28.
Kaplan SA, Walmsley K, Te AE. Tolterodine extended release attenuates lower urinary tract symptoms in men with benign prostatic hyperplasia. J Urol. 2005 Dec; 174(6): 2273-5 discussion 5-6.
Kaplan SA, Roehrborn CG, Dmochowski R, Rovner ES, Wang JT, Guan Z. Tolterodine extended release improves overactive bladder symptoms in men with overactive bladder and nocturia. Urology. 2006 Aug; 68(2): 328-32.
Athanasopoulos A, Gyftopoulos K, Giannitsas K, Fisfis J, Perimenis P, Barbalias G. Combination treatment with an alpha-blocker plus an anticholinergic for bladder outlet obstruction: a prospective, randomized, controlled study. J Urol. 2003 Jun; 169(6): 2253-6.
Lee KS, Choo MS, Kim DY, Kim JC, Kim HJ, Min KS, et al. Combination treatment with propiverine hydrochloride plus doxazosin controlled release gastrointestinal therapeutic system formulation for overactive bladder and coexisting benign prostatic obstruc- tion: a prospective, randomized, controlled multicenter study. J Urol. 2005 Oct; 174(4 Pt 1): 1334-8.
McConnell JD, Roehrborn CG, Bautista OM, Andriole GL, Jr., Dixon CM, Kusek JW, et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Engl J Med. 2003 Dec 18; 349(25): 2387-98.
