title: Results of a prospective, multicenter study evaluating quality of life, safety, and efficacy of sacral neuromodulation at twelve months in subjects with symptoms of overactive bladder.
abstract: OBJECTIVE
  This prospective, multicenter post-approval study evaluated the success rate of sacral neuromodulation (SNM) with the InterStim® System at 12-months. Subjects with bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (UI) or urgency-frequency (UF), who failed at least one anticholinergic medication and had at least one not tried were included.
  
  
  METHODS
  Subjects with successful test stimulation received an SNM implant. Therapeutic success (≥50% improvement in average leaks/day or voids/day or a return to normal voiding frequency [<8 voids/day]) and quality of life through 12 months were evaluated for implanted subjects.
  
  
  RESULTS
  Of the 340 subjects that went through test stimulation, 272 were implanted with SNM. Of these, 91% were female, mean age was 57, UI subjects had 3.1 ± 2.7 leaks/day, UF subjects had 12.6 ± 4.5 voids/day. The analysis which includes all implanted subjects with diary data at baseline and 12 months showed an OAB therapeutic success rate of 85% at 12 months. UI subjects had a mean reduction of 2.2 ± 2.7 leaks/day; UF subjects had a mean reduction of 5.1 ± 4.1 voids/day (both P < 0.0001). Subjects showed significant improvement from baseline in all measures of ICIQ-OABqol (all P < 0.0001). 80% of subjects reported improved changes in their urinary symptom interference at 12 months. Device-related adverse events occurred in 16% (56/340) of subjects during test stimulation and 30% (82/272) of subjects post-implant.
  
  
  CONCLUSIONS
  This multicenter study shows SNM is safe and effective and results in improved outcomes through 12 months in subjects with OAB symptoms, without requiring failure of all medications.
authors.affiliation: University of California, Riverside, California.
authors.forename: Karen
authors.initials: K
authors.lastname: Noblett
authors.affiliation: Metro Urology, Woodbury, Minnesota.
authors.forename: Steven
authors.initials: S
authors.lastname: Siegel
authors.affiliation: Metro Health Medical Center, Cleveland, Ohio.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Mangel
authors.affiliation: University of Kansas, Kansas City, Kansas.
authors.forename: Tomas L
authors.initials: TL
authors.lastname: Griebling
authors.affiliation: Metro Urology, Plymouth, Minnesota.
authors.forename: Suzette E
authors.initials: SE
authors.lastname: Sutherland
authors.affiliation: Scott and White Healthcare, Temple, Texas.
authors.forename: Erin T
authors.initials: ET
authors.lastname: Bird
authors.affiliation: Stanford University, Stanford, California.
authors.forename: Craig
authors.initials: C
authors.lastname: Comiter
authors.affiliation: University of Oklahoma HSC, Oklahoma City, Oklahoma.
authors.forename: Daniel
authors.initials: D
authors.lastname: Culkin
authors.affiliation: Female Pelvic Medicine, Grand Rapids, Michigan.
authors.forename: Jason
authors.initials: J
authors.lastname: Bennett
authors.affiliation: Milford Regional Medical Center, Whitinsville, Massachusetts.
authors.forename: Samuel
authors.initials: S
authors.lastname: Zylstra
authors.affiliation: Medtronic, Minneapolis, Minnesota.
authors.forename: Fangyu
authors.initials: F
authors.lastname: Kan
authors.affiliation: Medtronic, Minneapolis, Minnesota.
authors.forename: Kellie Chase
authors.initials: KC
authors.lastname: Berg
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058117:Neural Prostheses; D011446:Prospective Studies; D011788:Quality of Life; D020127:Recovery of Function; D012447:Sacrum; D062187:Spinal Cord Stimulation / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000294:innervation*; D053201:Urinary Bladder, Overactive / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D053202:Urinary Incontinence, Urge / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D014563:Urodynamics
keywords: overactive bladder; quality of life; sacral neuromodulation; urgency frequency; urinary incontinence