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Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim therapy compared to standard medical therapy at 6‐months in subjects with mild symptoms of overactive bladder
Author(s) -
Siegel Steven,
Noblett Karen,
Mangel Jeffrey,
Griebling Tomas L.,
Sutherland Suzette E.,
Bird Erin T.,
Comiter Craig,
Culkin Daniel,
Bennett Jason,
Zylstra Samuel,
Berg Kellie Chase,
Kan Fangyu,
Irwin Christopher P.
Publication year - 2015
Publication title -
neurourology and urodynamics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 90
eISSN - 1520-6777
pISSN - 0733-2467
DOI - 10.1002/nau.22544
Subject(s) - medicine , overactive bladder , adverse effect , randomized controlled trial , anticholinergic , sacral nerve stimulation , urinary incontinence , urology , alternative medicine , pathology
Aims This prospective, randomized, multicenter trial evaluated the 6‐month success rate of sacral neuromodulation (SNM) with InterStim® Therapy versus standard medical therapy (SMT) for overactive bladder (OAB). Methods Enrolled subjects discontinued OAB medications prior to and during baseline data collection and were randomized 1:1 to SNM or SMT. Subjects had bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (≥2 leaks/72 hr) and/or urgency‐frequency (≥8 voids/day). Subjects failed at least one anticholinergic medication, and had at least one medication not yet attempted. The primary objective was to compare OAB therapeutic success rate at 6 months between SNM and SMT. Results Overall, 147 subjects were randomized (70 to SNM and 77 to SMT); 93% were female and mean age was 58. The primary intent to treat analysis showed OAB therapeutic success was significantly greater in the SNM group (61%) than the SMT group (42%; P = 0.02). In the as treated analysis, OAB therapeutic success was 76% for SNM and 49% for SMT ( P = 0.002). The SNM group showed significant improvements in quality of life versus the SMT group (all P < 0.001) and 86% of SNM subjects reported improved or greatly improved urinary symptom interference score at 6 months, compared to 44% for SMT subjects. The device‐related adverse event rate was 30.5% and the medication‐related adverse event rate was 27.3%. Conclusions This study demonstrates superior objective and subjective success of SNM compared to SMT. SNM is shown to be a safe and effective treatment for OAB patients with mild to moderate symptoms. Neurourol. Urodynam. 34:224–230, 2015 . © 2014 Wiley Periodicals, Inc.