title: 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.
abstract: OBJECTIVE
  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.
authors.affiliation: Metro Urology, Woodbury, Minnesota.
authors.forename: Steven
authors.initials: S
authors.lastname: Siegel
authors.forename: Karen
authors.initials: K
authors.lastname: Noblett
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Mangel
authors.forename: Tomas L
authors.initials: TL
authors.lastname: Griebling
authors.forename: Suzette E
authors.initials: SE
authors.lastname: Sutherland
authors.forename: Erin T
authors.initials: ET
authors.lastname: Bird
authors.forename: Craig
authors.initials: C
authors.lastname: Comiter
authors.forename: Daniel
authors.initials: D
authors.lastname: Culkin
authors.forename: Jason
authors.initials: J
authors.lastname: Bennett
authors.forename: Samuel
authors.initials: S
authors.lastname: Zylstra
authors.forename: Kellie Chase
authors.initials: KC
authors.lastname: Berg
authors.forename: Fangyu
authors.initials: F
authors.lastname: Kan
authors.forename: Christopher P
authors.initials: CP
authors.lastname: Irwin
mesh_terms: D005260:Female; D006801:Humans; D008160:Lumbosacral Plexus; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012720:Severity of Illness Index; D062187:Spinal Cord Stimulation; D013997:Time Factors; D053201:Urinary Bladder, Overactive / Q000628:therapy*
keywords: anticholinergic; overactive bladder; sacral neuromodulation; urgency frequency; urinary incontinence