Solifenacin for overactive bladder with incontinence: symptom bother and health-related quality of life outcomes.
BACKGROUND
Approximately one-third of patients with overactive bladder (OAB) experience incontinence, a bothersome symptom with a clear negative effect on quality of life.


OBJECTIVE
To assess OAB patients' perceptions of improvements in symptom bother and quality of life after taking solifenacin under conditions reflecting day-to-day practice.


METHODS
VOLT (the VESIcare Open-Label Trial) was a prospective, open-label study in patients with OAB (defined as urgency, urge urinary incontinence, daytime frequency, or nocturia for > or =3 mo) who were treated with flexibly dosed, once-daily solifenacin for 12 weeks. This study included subjects enrolled in VOLT who, at baseline, had urge incontinence and reported incontinence as their most bothersome symptom. All patients were started on solifenacin 5 mg/day; at week 4, the dosage could be increased to 10 mg/day and at week 8 could be maintained or decreased back to 5 mg/day. Efficacy was assessed by 3 independent patient-reported outcomes: the Patient Perception of Bladder Condition (PPBC) scale, a visual analog scale (VAS) for assessing individual symptoms, and the Overactive Bladder Questionnaire (OAB-q).


RESULTS
Of the 2205 patients in the VOLT full analysis set, 1586 (71.9%) had urge incontinence at baseline, of which 582 (36.7%) reported incontinence as their most bothersome symptom. In this cohort, mean PPBC score at baseline was 4.6 (indicating moderate-to-severe problems) and at endpoint had decreased significantly to 2.9 (very minor to some minor problems; p < 0.001). At endpoint, 80.4% of patients achieved improvement in their PPBC score. These patients reported significant improvements from baseline in urinary urgency, urge incontinence, frequency, and nocturia on the VAS (p < 0.001) and all OAB-q domains (symptom severity, coping, concern, sleep, social, health-related quality of life) at endpoint (p < 0.001).


CONCLUSIONS
Patients reporting urge incontinence as their most bothersome OAB symptom can be expected to demonstrate significant improvements in multiple patient-related outcomes following treatment with flexibly dosed solifenacin.
Garely
Alan D
AD
Department of Obstetrics and Gynecology, Winthrop University Hospital, Mineola, NY 11501, USA. agarely@winthrop.org
Lucente
Vincent
V
Vapnek
Jonathan
J
Smith
Neila
N
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003248:Constipation / Q000139:chemically induced; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D011812:Quinuclidines / Q000009:adverse effects / Q000627:therapeutic use*; D000069464:Solifenacin Succinate; D044005:Tetrahydroisoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*; D014549:Urinary Incontinence / Q000188:drug therapy*; D014792:Visual Acuity / Q000187:drug effects; D014987:Xerostomia / Q000139:chemically induced
D018727:Muscarinic Antagonists; D011812:Quinuclidines; D044005:Tetrahydroisoquinolines; D000069464:Solifenacin Succinate