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


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.


BACKGROUND
ClinicalTrials.gov NCT00979472.
Department of Urology, Pusan National University Yangsan Hospital, Yangsan, Korea.
Ji-Yeon
JY
Han
Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Kyu-Sung
KS
Lee
Department of Urology, Inha University College of Medicine, Incheon, Korea.
Won Hee
WH
Park
Department of Urology, Keimyung University School of Medicine, Daegu, Korea.
Choal Hee
CH
Park
Department of Urology, Korea University College of Medicine, Seoul, Korea.
Jeong Gu
JG
Lee
Department of Urology, Pusan National University Hospital, Busan, Korea.
Jeong Zoo
JZ
Lee
Department of Urology, Catholic University of Daegu School of Medicine, Daegu, Korea.
Duk Yoon
DY
Kim
Department of Urology, Chungnam National University School of Medicine, Daejeon, Korea.
Yong Gil
YG
Na
Department of Urology, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Gwangju, Korea.
Dong Deuk
DD
Kwon
Department of Urology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Myung-Soo
MS
Choo
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011812:Quinuclidines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069464:Solifenacin Succinate; D044005:Tetrahydroisoquinolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy* / Q000503:physiopathology*
D018727:Muscarinic Antagonists; D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; D000069464:Solifenacin Succinate