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.
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References
Apostolidis A (2011) Neuromodulation for intractable OAB. Neurourol Urodynam 30:766–770
Noblett K (2016) Neuromodulation and female pelvic disorders. Curr Opin Urol 26(4):321–327
Brazzelli M, Murray A, Fraser C (2006) Efficacy and safety of sacral nerve stimulation for urinary urge incontinence; a systematic review. J Urol 175:835–841
Peeters K, Sahai A, De Ridder D, Van Der Aa F (2014) Long-term follow-up of sacral neuromodulation for lower urinary tract dysfunction. BJU Int 113:789–794
Cappellano F, Bertapelle P, Spinelli M, Catanzaro F, Carone R, Zanollo A, De Seta F, Giardiello G (2001) Quality of life assessment in patients who undergo sacral neuromodulation implantation for urge incontinence: an additional tool for evaluating outcome. J Urol 166(6):2277–2280
Ashok K, Wang A (2010) Detrusor overactivity: an overview. Arch Gynecol Obstet 282(1):33–41. doi:10.1007/s00404-010-1407-3
Siegel S, Noblett K, Mangel J, Griebling TL, Sutherland SE, Bird ET, Comiter C, Culkin D, Bennett J, Zylstra S, Kan F, Thiery E (2016) Three-year follow-up results of a prospective, multicenter study in overactive bladder subjects treated with sacral neuromodulation. Urology. doi:10.1016/j.urology.2016.04.024
Peters KM, Killinger KA, Gilleran JP, Bartley J, Wolfert C, Boura JA (2015) Predictors of reoperation after sacral neuromodulation: a single institution evaluation of over 400 patients. Neurourol Urodyn. doi:10.1002/nau.22929
Gormley EA, Lightner DJ, Faraday M, Vasavada SP (2015) Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment. J Urol 193:1572–1580
Siegel SW, Catanzaro F, Dijkema HE, Elhilali MM, Fowler CJ, Gajewski JB, Hassouna MM, Janknegt RA, Jonas U, Van Kerrebroeck PE, Lycklama a Nijeholt AA, Oleson KA, Schmidt RA (2000) Long-term results of a multicenter study on sacral nerve stimulation for treatment of urinary urge incontinence, urgency-frequency and retention. Urology 56(6 Suppl 1):87–91
Siddiqui N, Amundsen C, Corey E, Wu J (2011) Lead migration after sacral neuromodulation: surgical revision in fascial versus tined anchoring systems. Int Urogynecol J 22:419–423
Al-Zahrani A, Elzayat E, Gajewski J (2011) Long-term outcome and surgical interventions after sacral neuromodulation implant for lower urinary tract symptoms: 14-year experience at 1 center. J Urol 185:981–986
Van Voskuilen AC, Oerlemans DJ, Weil EH et al (2006) Long term results of neuromodulation by sacral nerve stimulation for lower urinary tract symptoms: a retrospective single center study. Eur Urol 49:366–372
Gaynor-Krupnick D, Dwyer N, Rittenmeyer H, Kreder K (2006) Evaluation and management of malfunctioning sacral neuromodulator. Urology 67:246–249
Wexner S, Hull T, Edden Y, Coller J, Devroede G, McCallum, Chan M, Ayscue J, Shobeiri A, Margolin D, England M, Kaufman H, Snape W, Mutlu E, Chua H, Pettit P, Nagle D, Madoff R, Lerew D, Mellgren D (2010) Infection rates in a large investigational trial of sacral nerve stimulation for fecal incontinence. J Gastrointest Surg 14:1081–1089
Hijaz A, Vasavada S, Daneshgari F, Frinjari, Goldman H, Rackley R (2006) Complications and troubleshooting of two-stage sacral neuromodulation therapy: a single-institution experience. Urology 68:533–537
White WM, Mobley JD III, Doggweiler R, Dobmeyer-Dittrich C, Klein FA (2009) Incidence and predictors of complications with sacral neuromodulation. Urology 73:731–735
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Christl Reisenauer received honoraria for speaking at symposia from Medtronic. The other authors declare that they have no conflict of interest.
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Kavvadias, T., Huebner, M., Brucker, S.Y. et al. Management of device-related complications after sacral neuromodulation for lower urinary tract disorders in women: a single center experience. Arch Gynecol Obstet 295, 951–957 (2017). https://doi.org/10.1007/s00404-017-4303-2
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DOI: https://doi.org/10.1007/s00404-017-4303-2