Medium-term outcomes of sacral neuromodulation in patients with refractory overactive bladder: A retrospective single-institution study.

Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE

Original Publication: San Francisco, CA : Public Library of Science

Electric Stimulation Therapy/*methods ; Lumbosacral Plexus/*pathology ; Sacrum/*pathology ; Urinary Bladder, Overactive/*therapy; Adult ; Aged ; Aged, 80 and over ; Female ; Follow-Up Studies ; Humans ; Middle Aged ; Retrospective Studies ; Treatment Outcome

Background: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
Competing Interests: The commercial affiliation "Clin-Science Research Consulting" [for DG] does not alter our adherence to PLOS ONE policies on sharing data and materials.

J Urol. 2019 May;201(5):967-972. (PMID: 31009968)
Adv Ther. 2020 Feb;37(2):637-643. (PMID: 31875299)
Urology. 2016 Aug;94:57-63. (PMID: 27131966)
Eur Urol. 2020 Feb;77(2):211-220. (PMID: 31733990)
Arch Gynecol Obstet. 2019 May;299(5):1243-1252. (PMID: 30941558)
BJU Int. 2001 Jun;87(9):760-6. (PMID: 11412210)
Am J Manag Care. 2009 Mar;15(4 Suppl):S90-7. (PMID: 19355803)
Int Urogynecol J. 2018 Aug;29(8):1081-1091. (PMID: 29302716)
Int Urol Nephrol. 2016 Jul;48(7):1029-36. (PMID: 27032397)
Urology. 2011 May;77(5):1081-7. (PMID: 21256571)
Eur Urol. 2018 Jul;74(1):66-73. (PMID: 29482936)
Urology. 2005 Oct;66(4):746-50. (PMID: 16230129)
J Urol. 2018 Jan;199(1):229-236. (PMID: 28709886)
Acta Obstet Gynecol Scand. 2013 Oct;92(10):1208-15. (PMID: 23763552)
Front Pharmacol. 2020 Jan 15;10:1618. (PMID: 32009968)
Neurourol Urodyn. 2018 Jun;37(5):1823-1848. (PMID: 29641846)
Am J Obstet Gynecol. 2005 Dec;193(6):2083-7. (PMID: 16325620)
Eur Urol. 2007 Oct;52(4):1204-12. (PMID: 17651893)
Neuromodulation. 2017 Dec;20(8):825-829. (PMID: 28967986)
BJU Int. 2008 Sep;102(7):774-9. (PMID: 18616691)
Res Rep Urol. 2016 Oct 26;8:193-199. (PMID: 27822462)
J Urol. 2011 Mar;185(3):981-6. (PMID: 21247597)
Int Urogynecol J. 2011 Dec;22(12):1549-54. (PMID: 21796469)
Obstet Gynecol. 2014 Oct;124(4):794-800. (PMID: 25198276)
Neurourol Urodyn. 2019 Feb;38(2):433-477. (PMID: 30681183)
Tech Coloproctol. 2020 Mar;24(3):215-220. (PMID: 31965400)
Int Urogynecol J. 2010 Dec;21 Suppl 2:S439-46. (PMID: 20972548)
Int Urogynecol J. 2011 Apr;22(4):407-12. (PMID: 20848271)
Res Rep Urol. 2016 Jun 06;8:71-6. (PMID: 27350947)
Neurourol Urodyn. 2010;29(1):4-20. (PMID: 19941278)
Eur Urol. 2006 Sep;50(3):440-52; discussion 453. (PMID: 16753253)
J Formos Med Assoc. 2019 Jan;118(1 Pt 2):279-284. (PMID: 29843924)
Neurourol Urodyn. 2018 Jun;37(5):1667-1671. (PMID: 29635879)
Neurourol Urodyn. 2016 Feb;35(2):246-51. (PMID: 25546568)
J Urol. 2010 Jan;183(1):173-6. (PMID: 19913835)
Neurourol Urodyn. 2007;26(1):29-35; discussion 36. (PMID: 17083097)
Female Pelvic Med Reconstr Surg. 2015 Nov-Dec;21(6):369-73. (PMID: 26506168)
World J Urol. 2003 May;20(6):327-36. (PMID: 12811491)
BJU Int. 2010 May;105(9):1276-82. (PMID: 19912188)
Urology. 2010 Mar;75(3):526-32, 532.e1-18. (PMID: 20035977)
J Urol. 2017 Oct;198(4):890-896. (PMID: 28501541)
Curr Bladder Dysfunct Rep. 2016 Mar;11(1):8-13. (PMID: 27057265)
J Urol. 2010 Apr;183(4):1438-43. (PMID: 20171677)

Date Created: 20200710 Date Completed: 20200917 Latest Revision: 20200917

20250114

PMC7347151

10.1371/journal.pone.0235961

32645082