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. Issue 3 (10th January 2014)

• Record Type: Journal Article
• Authors: 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.
• Is Part Of: Neurourology and urodynamics. Volume 34:Issue 3(2015:Mar.)
• Page Start: 224
• Page End: 230
• Publication Date: 2014-01-10
• Subjects: Urinary organs -- Periodicals; Urodynamics -- Periodicals; Urology -- Periodicals; 616.6
• DOI: 10.1002/nau.22544
• Languages: English
• ISSNs: 0733-2467

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="nau22544-sec-0001" sec-type="section"> <title>Aims</title> <p>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).</p> </sec> <sec id="nau22544-sec-0002" sec-type="section"> <title>Methods</title> <p>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.</p> </sec> <sec id="nau22544-sec-0003" sec-type="section"> <title>Results</title> <p>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%; <italic>P</italic> = 0.02). In the as treated analysis, OAB therapeutic success was 76% for SNM and 49% for SMT (<italic>P</italic> = 0.002). The SNM group showed significant improvements in quality of life versus the SMT group (all <italic>P</italic> < 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%.</p> </sec> <sec id="nau22544-sec-0004" sec-type="section"> <title>Conclusions</title> <p>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. <italic>Neurourol. Urodynam. 34:224–230, 2015</italic>. © 2014 Wiley Periodicals, Inc.</p> </sec> </abstract>