Tilemachos Kavvadias1,2, Markus Huebner1, Sara Yvonne Brucker1, Christl Reisenauer3. 1. Department of Obstetrics and Gynecology, University Hospital Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany. 2. Department of Obstetrics and Gynecology, University Hospital Basel, Spitalstrasse 21, 4031, Basel, Switzerland. 3. Department of Obstetrics and Gynecology, University Hospital Tuebingen, Calwerstrasse 7, 72076, Tuebingen, Germany. christl.reisenauer@ed.uni-tuebingen.de.
Abstract
PURPOSE: This study is aimed at presenting and discussing the device-related complication management during a 5-year period, of the sacral nerve modulation (SNM), in a tertiary-care university unit. METHODS: This is a retrospective chart review of all women, who received SNM in our department between May 2011 and May 2016. All two-stage procedures were performed by the same experienced surgeon and according to our strict protocol of patients' selection and follow-up. Data of perioperative and postoperative complications and their management were collected. RESULTS: The test stimulation was positive in 59 out of 64 patients (92%), who then received the permanent implantation after a mean test phase duration of 9 days. Mean overall follow-up was 16.5 (±10.9) months. We recorded 20 complications (31%) in 15 patients, after a mean follow-up time of 160 days. These comprise: lead migration (13.8%), infection (8.6%), pain (5.2%), wound healing disorders (5.2%) and lead fibrosis (10%). The event/patient ratio was significantly reduced from 0.6 in the beginning of our experience with SNM to 0.2 at the second period of the study (p = 0.005). All complications could be successfully resolved after surgical intervention without influence on the treatment effect. CONCLUSION: Complications after SNM are common and may require additional surgical intervention for full resolution but without affecting the treatment effect. Also, due to a learning curve, a lower events/patient ratio over time is to be expected.
PURPOSE: This study is aimed at presenting and discussing the device-related complication management during a 5-year period, of the sacral nerve modulation (SNM), in a tertiary-care university unit. METHODS: This is a retrospective chart review of all women, who received SNM in our department between May 2011 and May 2016. All two-stage procedures were performed by the same experienced surgeon and according to our strict protocol of patients' selection and follow-up. Data of perioperative and postoperative complications and their management were collected. RESULTS: The test stimulation was positive in 59 out of 64 patients (92%), who then received the permanent implantation after a mean test phase duration of 9 days. Mean overall follow-up was 16.5 (±10.9) months. We recorded 20 complications (31%) in 15 patients, after a mean follow-up time of 160 days. These comprise: lead migration (13.8%), infection (8.6%), pain (5.2%), wound healing disorders (5.2%) and lead fibrosis (10%). The event/patient ratio was significantly reduced from 0.6 in the beginning of our experience with SNM to 0.2 at the second period of the study (p = 0.005). All complications could be successfully resolved after surgical intervention without influence on the treatment effect. CONCLUSION: Complications after SNM are common and may require additional surgical intervention for full resolution but without affecting the treatment effect. Also, due to a learning curve, a lower events/patient ratio over time is to be expected.
Authors: Thomas C Dudding; Paul A Lehur; Michael Sørensen; Stefan Engelberg; Maria Paola Bertapelle; Emmanuel Chartier-Kastler; Karel Everaert; Philip Van Kerrebroeck; Charles H Knowles; Lilli Lundby; Klaus E Matzel; Arantxa Muñoz-Duyos; Mona B Rydningen; Stefan de Wachter Journal: Neuromodulation Date: 2021-07-15