Sacral neuromodulation (SNM) is a minimally invasive fully reversible therapy that was approved in 1997 for overactive bladder syndrome (OAB) refractory to behavior modification and pharmacotherapy. Despite being in use for over two decades, the data on medium to long-term safety and efficacy of SNM in OAB is limited. We investigated the medium-term efficacy and safety of SNM along with the predictive factors for its success in patients with refractory OAB.
A retrospective consecutive case series of 66 patients undergoing SNM for refractory OAB between July 2009 and July 2018. All patients underwent a test period followed by permanent implantation, if there was > = 50% improvement in any symptom. The primary outcome was "success" defined as > = 50% improvement in any clinical parameter based on the subjective assessment of patient's response. The secondary outcomes were number of pads used in 24 hours, post-operative complications and re-operation rates.
66 females with an average age of 62.7 years were included. 55/66 patients (83.3%) had a successful test phase and underwent permanent implantation. After a median follow-up of 32 months, SNM was successful in 41/55 (74.5%) patients. Mean number of pads used in 24 hours decreased significantly from 3.5 preoperatively to 1.2 at last follow-up (p<0.001). 8/55 (14.5%) patients reported complications of pain, lead migration, wound dehiscence and device malfunction. 10/55 (18.2%) patients underwent revision surgeries after a median duration of 21.9 months. Device was explanted in 15/55 (27.3%) patients after a median duration of 24 months. No significant predictor for success was identified.
The success rate of SNM is 75% with a complication rate of 14.5% after a median follow-up of ~3 years. This study suggests medium-term efficacy and safety but a high re-operation rate of SNM in patients with refractory OAB.
PloS one. 2020 Jul 09*** epublish ***
Bilal Kaaki, Digant Gupta
Des Moines University, Des Moines, Iowa, United States of America., Clin-Science Research Consulting, Chicago, Illinois, United States of America.