Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Lower Urinary Tract Symptoms—ASSIST, Randomized Controlled Study

• Published in: Urology (Ridgewood, N.J.) N.J.), 2011-07, Vol.78 (1), p.126-133
• Main Authors: Yamaguchi, Osamu, Kakizaki, Hidehiro, Homma, Yukio, Takeda, Masayuki, Nishizawa, Osamu, Gotoh, Momokazu, Yokoyama, Osamu, Seki, Narihito, Yoshida, Masaki
• Format: Article
• Language: English
• Subjects: Adrenergic alpha-1 Receptor Antagonists - therapeutic use; Aged; Aged, 80 and over; Biological and medical sciences; Double-Blind Method; Drug Therapy, Combination; Humans; Male; Medical sciences; Middle Aged; Muscarinic Antagonists - therapeutic use; Nephrology. Urinary tract diseases; Prostatism - drug therapy; Quinuclidines - therapeutic use; Solifenacin Succinate; Sulfonamides - therapeutic use; Tetrahydroisoquinolines - therapeutic use; Urinary Bladder, Overactive - drug therapy; Urinary system involvement in other diseases. Miscellaneous; Urinary tract. Prostate gland; Urology
• ISSN: 0090-4295; 1527-9995
• DOI: 10.1016/j.urology.2011.02.055

Objectives To assess the efficacy and safety of solifenacin add-on therapy to tamsulosin in lower urinary tract symptoms (LUTS) men with residual overactive bladder (OAB) symptoms despite tamsulosin monotherapy. Methods In this randomized, multicenter, double-blind study, male LUTS patients aged ≥50 years with urgency episodes/24 hours ≥2 and micturitions/24 hours ≥8 were randomized to 3 groups: 12-weeks tamsulosin plus placebo (TAM + PBO), tamsulosin plus solifenacin 2.5 mg (TAM + SOL), and tamsulosin plus solifenacin 5 mg (TAM + SOL). Changes from baseline to end of treatment in the number of urgency episodes/24 hours (primary endpoint), micturitions, nocturia, urgency incontinence episodes, International Prostate Symptom Scores (IPSS), and Overactive Bladder Symptom Score (OABSS) were compared between the TAM + SOL groups and TAM + PBO. Safety was assessed on adverse events, postvoid residual volume, and maximal urinary flow rate (Qmax. ). Results Six-hundred thirty-eight men were randomized. Urgency was reduced by 2.2 and 2.4 episodes in the TAM + SOL 2.5 and 5 mg groups, respectively. The TAM + SOL 5 mg group showed significant improvement compared with TAM + PBO (−2.4 vs −1.9, P = .049). The number of micturitions in both TAM + SOL groups were significantly reduced compared with TAM + PBO (both P