A comparative study on the efficacy of solifenacin succinate in patients with urinary frequency with or without urgency

• Published in: PloS one 2014-11, Vol.9 (11), p.e112063-e112063
• Main Authors: Han, Ji-Yeon, Lee, Kyu-Sung, Park, Won Hee, Park, Choal Hee, Lee, Jeong Gu, Lee, Jeong Zoo, Kim, Duk Yoon, Na, Yong Gil, Kwon, Dong Deuk, Choo, Myung-Soo
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Biology and Life Sciences; Bladder; Care and treatment; Comparative analysis; Comparative studies; Diaries; Effectiveness; Empirical analysis; Female; Humans; Male; Medical research; Medicine; Medicine and Health Sciences; Middle Aged; Muscarinic Antagonists - administration & dosage; Muscarinic Antagonists - adverse effects; Muscarinic Antagonists - therapeutic use; Patients; Quinuclidines - administration & dosage; Quinuclidines - adverse effects; Quinuclidines - therapeutic use; Research and Analysis Methods; Solifenacin Succinate; Standard error; Systematic review; Tetrahydroisoquinolines - administration & dosage; Tetrahydroisoquinolines - adverse effects; Tetrahydroisoquinolines - therapeutic use; Treatment Outcome; Urinary bladder; Urinary Bladder, Overactive - drug therapy; Urinary Bladder, Overactive - physiopathology; Urinary incontinence; Urinary tract diseases; Urinary tract infections; Urination; Urine; Urogenital system; Urology
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0112063

Patients with overactive bladder (OAB) often have trouble perceiving urgency because of difficulties in distinguishing between urgency and desire to void. Empirical antimuscarinic treatment of patients with frequency only may be reasonable if conservative management has failed. We compared the efficacy of solifenacin in patients with frequency with or without urgency. This multicenter, 12-week, open-label, comparative, non-inferiority clinical trial assessed whether the solifenacin efficacy for frequency without urgency is non-inferior to its efficacy for frequency with urgency. All patients had micturition frequency ≥ 8 voids/day with or without urgency. Primary efficacy variable: daily frequency change at 12 weeks relative to baseline. Secondary efficacy variables: change at 12 weeks relative to baseline in Patients' Perception of Bladder Condition (PPBC), OAB Symptom Score (OABSS), and Benefit, Satisfaction, Willingness to continue (BSW) questionnaire. Of the 286 enrolled patients, 240 (83.9%) completed the study (without urgency n = 115; with urgency n = 125). Full dataset analysis revealed that the groups without and with urgency exhibited significant reductions in daily micturition frequency of -2.49 ± 0.35 (mean ± standard error) and -2.63 ± 0.37, respectively. The lower limit of the 95% two-sided CI of the comparison of the two group means was -1.14, which is smaller than the -0.8 margin of clinical equivalence. The two groups did not differ in improvement in PPBC, OABSS, or BSW scores. Both tolerated the treatment well. It was not possible to verify that the solifenacin efficacy for frequency alone was non-inferior to its efficacy for OAB. Nevertheless, solifenacin tended to be effective for frequency regardless of urgency. ClinicalTrials.gov NCT00979472.