Authors' objectives:

The aim of this review was to assess the effectiveness, safety, and cost of sacral nerve stimulation (SNS) to treat urinary urge incontinence, urgency-frequency, urinary retention, and fecal incontinence.

Authors' results and conclusions: Urge Incontinence: Two RCTs were identified that compared SNS to no treatment in patients with refractory urge incontinence. Both RCTs reported significant improvements (> 50% improvement in voiding function) in the SNS group for number of incontinence episodes per day, number of pads used per day, and severity of incontinence episodes. Urgency-Frequency (With or Without Chronic Pelvic Pain): One RCT was identified that compared SNS to no treatment in patients with refractory urgency-frequency. The RCT reported significant improvements in urgency-frequency symptoms in the SNS group (average volume per void, detrusor pressure). In addition to the RCT, 1 retrospective review and 2 prospective case series were identified that measured pelvic pain associated with urgency-frequency in patients who underwent SNS. All 3 studies reported a significant decrease in pain at median follow-up. Urinary Retention: One RCT was identified that compared SNS to no treatment in patients with refractory urinary retention. The RCT reported significant improvements in urinary retention in the SNS group compared to the control group for number of catheterizations required and number of voids per day. In addition to this RCT, 1 case series was also identified investigating SNS in women with urinary retention. This study also found that there were significant improvements in urinary retention after the women had received the SNS implants. Fecal Incontinence: Three case series were identified that investigated the role of SNS in patients with fecal incontinence. All 3 reported significant improvements in fecal incontinence symptoms (number of incontinent episodes per week) after the patients received the SNS implants. Long-Term Follow-up: None of the studies identified followed patients until the point of battery failure. Of the 6 studies identified describing the long-term follow-up of patients with SNS, follow-up periods ranged from 1.5 years to over 5 years. None of the long-term follow-up studies included patients with fecal incontinence. All of the studies reported that most of the patients who had SNS had at least a 50% improvement in voiding function (range 58%77%). These studies also reported the number of patients who had their device explanted in the follow-up period. The rates of explantation ranged from 12% to 21%. Safety, Complications, and Quality of Life: A 33% surgical revision rate was reported in an analysis of the safety of 3 RCTs comparing SNS to no treatment in patients with urge incontinence, urgency-frequency, or urinary retention. The most commonly reported adverse effects were pain at the implant site and lead migration. Despite the high rate of surgical revision, there were no reports of permanent injury or death in any of the studies or health technology assessments identified. Additionally, patients consistently said that they would recommend the procedure to a friend or family member.

Authors' recommendations: In summary, there is level 2 evidence to support the effectiveness of SNS to treat people with urge incontinence, urgency-frequency, or urinary retention. There is level 4 evidence to support the effectiveness of SNS to treat people with fecal incontinence. To qualify for SNS, people must meet the following criteria: - Be refractory to behaviour and/or drug therapy - Have had a successful test stimulation before implantation; successful test stimulation is defined by a 50% or greater improvement in voiding function based on the results of a voiding diary. Test stimulation periods range from 3 to 7 days for patients with urinary dysfunctions, and from 2 to 3 weeks for patients with fecal incontinence. - Be able to record voiding diary data, so that clinical results of the implantation can be evaluated. Patients with stress incontinence, urinary retention due to obstruction and neurogenic conditions (such as diabetes with peripheral nerve involvement) are ineligible for sacral nerve stimulation. Physicians will need to learn how to use the InterStim System for Urinary Control. Requirements for training include these: - Physicians must be experienced in the diagnosis and treatment of lower urinary tract disorders and should be trained in the implantation and use of the InterStim System for Urinary Control. - Training should include the following: a. Participation in a seminar or workshop that includes instructional and laboratory training on SNS. This seminar should include a review of the evidence on SNS with emphasis on techniques to prevent adverse events. b. Completion of proctoring by a physician experienced in SNS for the first 2 test stimulations and the first 2 implants.

Authors' methods: Systematic review

Project Status: Completed

Year Published: 2005

URL for published report: http://www.health.gov.on.ca/english/providers/program/mas/tech/reviews/pdf/rev_sns_030105.pdf

URL for additional information: http://www.hqontario.ca/evidence/publications-and-ohtac-recommendations/ohtas-reports-and-ohtac-recommendations/sacral-nerve-stimulation-for-the-management-of-urge-incontinence-urgency-frequency-urinary-retention-and-fecal-incontinence

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Canada

Organisation Name: Medical Advisory Secretariat

Contact Address: Medical Advisory Secretariat, 20 Dundas Street West, 10th Floor, Toronto, ON M5G 2N6 CANADA. Tel: 416-314-1092l; Fax: 416-325-2364;

Contact Name: MASinfo.moh@ontario.ca

Contact Email: MASinfo.moh@ontario.ca

Copyright: Medical Advisory Secretariat, Ontario Ministry of Health and Long-Term Care