title: A New Implanted Posterior Tibial Nerve Stimulator for the Treatment of Overactive Bladder Syndrome: 3-Month Results of a Novel Therapy at a Single Center.
abstract: This study was designed to investigate the safety and performance of a new implantable system for tibial nerve stimulation for overactive bladder symptoms.
  
  
  
  A battery-free stimulation device for tibial nerve stimulation (BlueWind Medical, Herzliya, Israel) was implanted in 15 patients. Safety and efficacy assessments were done at 3 months after activation with a 3-day bladder diary, a 24-hour pad test and 2 quality of life questionnaires.
  
  
  
  Two males and 13 females were enrolled in the study. Mean age was 54 years (range 19 to 72). Five of 15 patients were previously treated with percutaneous tibial nerve stimulation and 12 experienced urgency urinary incontinence. Median operative time was 34 minutes. At 3 months of followup a significant change was seen in 24-hour frequency from a mean ± SD of 11.8 ± 3.5 to 8.1 ± 2.0 times per day (p = 0.002), the number of severe urinary urgency episodes from 6.5 ± 5.1 to 2.0 ± 2.1 times per day (p = 0.002), the number of severe incontinence episodes from 2.8 ± 5.2 to 0.3 ± 0.4 episodes per day (p = 0.017), urinary loss per day from 243 ± 388 to 39 ± 55 gm (p = 0.038) and improvement in quality of life. After implantation, 3 patients received prolonged antibiotic treatment and 3 received pain medication for 1 week. In 1 patient the device was explanted due to pain and swelling suspicious for infection, although tissue cultures did not reveal a bacterial infection.
  
  
  
  This novel posterior tibial nerve stimulator is safe and easy to implant with good clinical results.
authors.affiliation: Radboud Medical Center (HMKvB, JPFAH), Nijmegen, The Netherlands. Electronic address: H.M.K.vanbreda@umcutrecht.nl.
authors.forename: Hendrikje M K
authors.initials: HMK
authors.lastname: van Breda
authors.affiliation: Radboud Medical Center (HMKvB, JPFAH), Nijmegen, The Netherlands.
authors.forename: Frank M J
authors.initials: FMJ
authors.lastname: Martens
authors.affiliation: Radboud Medical Center (HMKvB, JPFAH), Nijmegen, The Netherlands.
authors.forename: Johnny
authors.initials: J
authors.lastname: Tromp
authors.affiliation: Radboud Medical Center (HMKvB, JPFAH), Nijmegen, The Netherlands.
authors.forename: John P F A
authors.initials: JPFA
authors.lastname: Heesakkers
mesh_terms: D000328:Adult; D000368:Aged; D015331:Cohort Studies; D004567:Electrodes, Implanted; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D011788:Quality of Life; D013979:Tibial Nerve; D004561:Transcutaneous Electric Nerve Stimulation / Q000295:instrumentation*; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000628:therapy*; D055815:Young Adult
keywords: electric stimulation; implantable neurostimulators; overactive; prostheses and implants; urge; urinary bladder; urinary incontinence