Decompression and transposition of the pudendal nerve in pudendal neuralgia: A randomized controlled trial. and long-term evaluation

Background: We assess that pudendal neuralgia is a tunnel syndrome due to a ligamentous entrapment of the pudendal nerve and have treated 400 patients surgically since 1987. We have had no major complication. We conducted a randomized controlled trial to evaluate our procedure. Methods: A sequential, randomized controlled trial to compare decompression of the pudendal nerve with nonsurgical treatment. Patients aged 18-70, had chronic, uni/bilateral perineal pain, positive temporary response to blocks at the ischial spine and in Alcock's canal. They were randomly assigned to surgery (n = 16) and control (n = 16) groups. Primary end point was improvement at 3 months following surgery or assignment to the non-surgery group. Secondary end points were improvement at 12 months and at 4 years following surgical intervention. Results: A significantly higher proportion of the surgery group was improved at 3 months. On intention-to-treat analysis 50% of the surgery group reported improvement in pain at 3 months versus 6.2% of the non-surgery group (p = .0155); in the analysis by treatment protocol the figures were 57.1% versus 6.7% (p = .0052). At 12 months, 71.4% of the surgery group compared with 13.3% of the non-surgery group were improved, analyzing by treatment protocol (p = .0025). Only those randomized to surgery were evaluated at 4 years: 8 remained improved at 4 years. No complications were encountered. Conclusions: In this study we demonstrate that decompression of the pudendal nerve is an effective and safe treatment for cases of chronic pudendal neuralgia that have been unresponsive to analgesia and nerve blocks. Following surgery, other medical interventions may be necessary. (C) 2004 Elsevier B.V. All rights reserved.