title: Sacral neuromodulation in the treatment of urgency-frequency symptoms: a multicenter study on efficacy and safety.
abstract: OBJECTIVE
  Neuromodulation of sacral nerves has shown promising results in correcting voiding dysfunction. We report the results of a multicenter trial designed to assess the efficacy of sacral nerve neuromodulation in patients presenting with refractory urinary urgency-frequency.
  
  
  METHODS
  A total of 51 patients from 12 centers underwent baseline assessment, including a detailed voiding diary, urodynamic evaluation and percutaneous test stimulation of the sacral nerves at S3 and/or S4. All patients enrolled in the study had undergone prior conventional treatment, such as pharmacotherapy, hydrodistention and surgical intervention, which failed. All patients demonstrated a satisfactory response to trial stimulation and were randomly divided into a stimulation group (25 patients) and a control group (26). A sacral nerve stimulation device was implanted after 6 months in the control group. Patients were followed at 1, 3 and 6 months, and at 6-month intervals for up to 2 years after implantation of a neuroprosthetic InterStim* system. dagger The study variables included the number of voids daily, volume voided per void and degree of urgency before void.
  
  
  RESULTS
  Compared to the control group, 6-month voiding diary results demonstrated statistically significant improvements (p <0.0001) in the stimulation group with respect to the number voids daily (16.9 +/- 9.7 to 9.3 +/- 5.1), volume per void (118 +/- 74 to 226 +/- 124 ml.) and degree of urgency (rank 2.2 +/- 0.6 to 1.6 +/- 0.9). Patients in the control group showed no significant changes in voiding parameters at 6 months. Significant improvements in favor of the stimulation group were noted in various parameters with respect to water cystometry and quality of life (SF-36). At 6 months after implant, neurostimulators were turned off in the stimulation group and urinary symptoms returned to baseline values. After reactivation of stimulation sustained efficacy was documented at 12 and 24 months.
  
  
  CONCLUSIONS
  Neuromodulation of the sacral nerves is an effective, safe therapy that successfully treats significant symptoms of refractory urgency-frequency.
authors.affiliation: Toronto Hospital Western Division, Toronto, Ontario, Royal Victoria Hospital, Montreal, Quebec, Canada.
authors.forename: M M
authors.initials: MM
authors.lastname: Hassouna
authors.forename: S W
authors.initials: SW
authors.lastname: Siegel
authors.forename: A A
authors.initials: AA
authors.lastname: Nÿeholt
authors.forename: M M
authors.initials: MM
authors.lastname: Elhilali
authors.forename: P E
authors.initials: PE
authors.lastname: van Kerrebroeck
authors.forename: A K
authors.initials: AK
authors.lastname: Das
authors.forename: J B
authors.initials: JB
authors.lastname: Gajewski
authors.forename: R A
authors.initials: RA
authors.lastname: Janknegt
authors.forename: D A
authors.initials: DA
authors.lastname: Rivas
authors.forename: H
authors.initials: H
authors.lastname: Dijkema
authors.forename: D F
authors.initials: DF
authors.lastname: Milam
authors.forename: K A
authors.initials: KA
authors.lastname: Oleson
authors.forename: R A
authors.initials: RA
authors.lastname: Schmidt
mesh_terms: D000328:Adult; D004599:Electric Stimulation Therapy; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D019736:Prostheses and Implants; D012445:Sacrococcygeal Region / Q000294:innervation; D014555:Urination Disorders / Q000503:physiopathology / Q000601:surgery*; D014563:Urodynamics