Kenneth M Peters1, Kevin M Feber, Richard C Bennett. 1. Department of Urology, Ministrelli Program for Urologic Research and Education (MPURE), William Beaumont Hospital, Royal Oak, Michigan 48073, USA. kmpeters@beaumont.edu
Abstract
AIMS: The objective of the study was to compare sacral nerve stimulation (SNS) to pudendal nerve stimulation (PNS) for voiding dysfunction. METHODS:Thirty subjects with voiding dysfunction had a tined lead placed at S3 and a second electrode implanted at the pudendal nerve via a posterior approach. In a blinded, randomized fashion, each lead was tested for 7 days. Voiding diaries and questionnaires were completed and outcomes monitored. RESULTS: The time to place a sacral lead was 25.85 min, pudendal lead 23.71 min (P = 0.57). Twenty-four of 30 (80%) subjects responded and had a permanent implant placed. PNS was chosen as a superior lead in 79.2%, SNS was superior in 20.8%. The order in which the lead was simulated had no impact on the final lead implanted and no carry over effect was seen. Overall reduction in symptoms was 63% for PNS and 46% for SNS (P = 0.02). On a 7-point scale from markedly worse to markedly better, the pudendal lead was superior to sacral for pelvic pain (P = 0.024), urgency (P = 0.005), frequency (P = 0.007), and bowel function (P = 0.049). Complications were minimal. CONCLUSIONS: This is the first blinded study of sacral versus pudendal stimulation for voiding dysfunction. Successful implantation of a pudendal lead was achieved in all subjects. The majority of subjects chose PNS to be superior to SNS. More patients and longer term data is needed to confirm these promising results. (c) 2005 Wiley-Liss, Inc.
RCT Entities:
AIMS: The objective of the study was to compare sacral nerve stimulation (SNS) to pudendal nerve stimulation (PNS) for voiding dysfunction. METHODS: Thirty subjects with voiding dysfunction had a tined lead placed at S3 and a second electrode implanted at the pudendal nerve via a posterior approach. In a blinded, randomized fashion, each lead was tested for 7 days. Voiding diaries and questionnaires were completed and outcomes monitored. RESULTS: The time to place a sacral lead was 25.85 min, pudendal lead 23.71 min (P = 0.57). Twenty-four of 30 (80%) subjects responded and had a permanent implant placed. PNS was chosen as a superior lead in 79.2%, SNS was superior in 20.8%. The order in which the lead was simulated had no impact on the final lead implanted and no carry over effect was seen. Overall reduction in symptoms was 63% for PNS and 46% for SNS (P = 0.02). On a 7-point scale from markedly worse to markedly better, the pudendal lead was superior to sacral for pelvic pain (P = 0.024), urgency (P = 0.005), frequency (P = 0.007), and bowel function (P = 0.049). Complications were minimal. CONCLUSIONS: This is the first blinded study of sacral versus pudendal stimulation for voiding dysfunction. Successful implantation of a pudendal lead was achieved in all subjects. The majority of subjects chose PNS to be superior to SNS. More patients and longer term data is needed to confirm these promising results. (c) 2005 Wiley-Liss, Inc.
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