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UROLOGY

Solifenacin for Overactive Bladder with Incontinence: Symptom Bother and Health-Related Quality of Life Outcomes

Chief of Gynecology and Director of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, Winthrop University Hospital, Mineola, NY

Vincent Lucente, MD

Medical Director, Institute for Female Pelvic Medicine, Allentown, PA

Jonathan Vapnek, MD

Clinical Associate Professor, Department of Urology, Mt. Sinai School of Medicine, New York, NY

Neila Smith, MD

Senior Medical Director, Pharmacovigilence, Astellas Pharma US, Inc., Deerfield, IL

Reprints: Dr. Garely, Winthrop University Hospital, 120 Mineola Blvd., Ste. 100, Mineola, NY 11501, fax 516/663-3026, agarely{at}winthrop.org

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 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.

Key Words: incontinence, overactive bladder, solifenacin, urgency

Published Online, March 6, 2007. www.theannals.com, DOI 10.1345/aph.1H581