Sacral neuromodulation in the management of chronic pelvic pain: A systematic review and meta‐analysis

INTRODUCTION Sacral neuromodulation (SNM) is a treatment approved for use in several conditions including refractory overactive bladder (OAB) and voiding dysfunction. Chronic pelvic pain (CPP) is a debilitating condition for which treatment is often challenging. SNM shows promising effect in patients with refractory CPP. However, there is a lack of clear evidence, especially in long-term outcomes. This systematic review will assess outcomes of SNM for treating CPP. METHODS A systematic search of MEDLINE, Embase, Cochrane Central and clinical trial databases was completed from database inception until January 14, 2022. Studies using original data investigating SNM in an adult population with CPP which recorded pre and posttreatment pain scores were selected. Primary outcome was numerical change in pain score. Secondary outcomes were quality of life assessment and change in medication use and all-time complications of SNM. Risk of bias was assessed using the Newcastle Ottawa Tool for cohort studies. RESULTS Twenty-six of 1026 identified articles were selected evaluating 853 patients with CPP. The implantation rate after test-phase success was 64.3%. Significant improvement of pain scores was reported in 13 studies; three studies reported no significant change. WMD in pain scores on a 10-point scale was -4.64 (95% confidence interval [CI] = -5.32 to -3.95, p < 0.00001) across 20 studies which were quantitatively synthesized: effects were maintained at long-term follow-up. Mean follow-up was 42.5 months (0-59). Quality of life was measured by RAND SF-36 and EQ-5D questionnaires and all studies reported improvement in quality of life. One hundred and eighty-nine complications were reported in 1555 patients (Clavien-Dindo Grade I-IIIb). Risk of bias ranged from low to high risk. Studies were case series and bias stemmed from selection bias and loss to follow-up. CONCLUSION Sacral Neuromodulation is a reasonably effective treatment of Chronic Pelvic Pain and significantly reduces pain and increases patients' quality of life with immediate to long-term effects.

[1]  M. Dale,et al.  Axonics Sacral Neuromodulation System for Treating Refractory Overactive Bladder: A NICE Medical Technologies Guidance , 2021, Applied Health Economics and Health Policy.

[2]  H. O'Connell,et al.  Efficacy of sacral neuromodulation and percutaneous tibial nerve stimulation in the treatment of chronic nonobstructive urinary retention: A systematic review , 2021, Neurourology and urodynamics.

[3]  E. Mayo-Wilson,et al.  The PRISMA 2020 statement: an updated guideline for reporting systematic reviews , 2021, BMJ.

[4]  K. Sievert,et al.  Systematic Literature Review and Meta-Analysis of Sacral Neuromodulation (SNM) in Patients with Neurogenic Lower Urinary Tract Dysfunction (nLUTD): Over 20 Years’ Experience and Future Directions , 2021, Advances in Therapy.

[5]  B. Padilla-Fernández,et al.  Long-term Outcomes of Sacral Nerve Stimulation in Pelvic Floor Dysfunctions , 2021, International neurourology journal.

[6]  J. Gajewski,et al.  Long‐term outcomes of sacral neuromodulation for lower urinary tract dysfunction: A 23‐year experience , 2020, Neurourology and urodynamics.

[7]  E. Uhl,et al.  Interdisciplinary Laparoscopic Implantation of Neuromodulation Leads to the Sacral Plexus for Therapy of Chronic Pelvic Pain and Neurogenic Bladder Dysfunctions , 2020, Neuromodulation : journal of the International Neuromodulation Society.

[8]  C. Böckelman,et al.  Outcomes of sacral neuromodulation for chronic pelvic pain: a Finnish national multicenter study , 2020, Techniques in Coloproctology.

[9]  J. Borovička,et al.  Benefits and Harms of Electrical Neuromodulation for Chronic Pelvic Pain: A Systematic Review. , 2020, European urology focus.

[10]  E. Isagulyan,et al.  Experience of combined pudendal and sacral electrostimulation in a patient with chronic pelvic pain , 2019, Urologicheskie vedomosti.

[11]  S. Marinkovic Improving clinical outcomes with lower motor voltage (≤3 V) during stage 1 sacral neuromodulation for interstitial cystitis or bladder pain syndrome , 2019, Neurourology and urodynamics.

[12]  Peng Zhang,et al.  Results of Sacral Neuromodulation Therapy for Urinary Voiding Dysfunction: Five‐Year Experience of a Retrospective, Multicenter Study in China , 2019, Neuromodulation : journal of the International Neuromodulation Society.

[13]  A. Goebel,et al.  Classical Predictors Do Not Predict Success with Sacral Nerve Stimulation for Chronic Pelvic Pain; A Retrospective Review in a Single Center. , 2019, Pain medicine.

[14]  S. El-Nashar,et al.  Sacral neuromodulation treating chronic pelvic pain: a meta-analysis and systematic review of the literature , 2019, International Urogynecology Journal.

[15]  S. As-Sanie,et al.  Psychology of Chronic Pelvic Pain: Prevalence, Neurobiological Vulnerabilities, and Treatment , 2019, Clinical obstetrics and gynecology.

[16]  W. Zhimin,et al.  Treatment Outcome of Acute Sacral Nerve Stimulation in Functional Anorectal Pain , 2019, Pain practice : the official journal of World Institute of Pain.

[17]  Amy D. Dobberfuhl,et al.  Statewide Success of Staged Sacral Neuromodulation for the Treatment of Urinary Complaints in California (2005-2011). , 2018, Female pelvic medicine & reconstructive surgery.

[18]  M. Spinelli,et al.  Efficacy and Safety of Sacral and Percutaneous Tibial Neuromodulation in Non-neurogenic Lower Urinary Tract Dysfunction and Chronic Pelvic Pain: A Systematic Review of the Literature. , 2018, European urology.

[19]  T. Vancaillie,et al.  Sacral neuromodulation for pelvic pain and pelvic organ dysfunction: A case series , 2018, The Australian & New Zealand journal of obstetrics & gynaecology.

[20]  K. Matzel,et al.  Sacral Neuromodulation: Standardized Electrode Placement Technique , 2017, Neuromodulation : journal of the International Neuromodulation Society.

[21]  W. Artibani,et al.  Cycling Sacral Root Neuromodulation: Pilot Study to Assess the Effectiveness of This Mode in Neuromodulator Programming for the Treatment of Chronic Pelvic Pain Syndrome , 2017 .

[22]  Peng Wu,et al.  Sacral Neuromodulation for Refractory Bladder Pain Syndrome/Interstitial Cystitis: a Global Systematic Review and Meta-analysis , 2017, Scientific Reports.

[23]  David Sánchez Poveda,et al.  Caudal Neuromodulation with the Transforaminal Sacral Electrode (InterStim®): Experience in a Pain Center Regarding 12 Implants , 2016, The Korean journal of pain.

[24]  P. Sokal,et al.  Sacral roots stimulation in chronic pelvic pain. , 2015, Neurologia i neurochirurgia polska.

[25]  C. Vaizey,et al.  Sacral nerve stimulation: an effective treatment for chronic functional anal pain? , 2013, Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland.

[26]  D. Srivastava Efficacy of sacral neuromodulation in treating chronic pain related to painful bladder syndrome/interstitial cystitis in adults , 2012, Journal of anaesthesiology, clinical pharmacology.

[27]  G. Naldini,et al.  Sacral nerve modulation in the treatment of chronic pelvic pain , 2012, International Journal of Colorectal Disease.

[28]  M. Hassouna,et al.  Efficacy of sacral neuromodulation in treatment of bladder pain syndrome: Long‐term follow‐up , 2011, Neurourology and urodynamics.

[29]  M. Bhandari,et al.  Three-minute critical appraisal of a case series article , 2011, Indian journal of orthopaedics.

[30]  M. van Kleef,et al.  Sacral Neuromodulation for the Treatment of Chronic Functional Anorectal Pain: A Single Center Experience , 2010, Pain practice : the official journal of World Institute of Pain.

[31]  B. Schurch,et al.  Sacral Neuromodulation for Refractory Lower Urinary Tract Dysfunction: Results of a Nationwide Registry in Switzerland , 2007 .

[32]  C. Signorelli,et al.  Sacral Nerve Stimulation With Percutaneous Dorsal Transforamenal Approach in Treatment of Isolated Pelvic Pain Syndromes , 2006, Neuromodulation : journal of the International Neuromodulation Society.

[33]  A. Diokno,et al.  Sacral neuromodulation in patients with interstitial cystitis: a multicenter clinical trial , 2003, International Urogynecology Journal.

[34]  C. Comiter Sacral neuromodulation for the symptomatic treatment of refractory interstitial cystitis: a prospective study. , 2003, The Journal of urology.

[35]  K. Zondervan,et al.  The community prevalence of chronic pelvic pain in women and associated illness behaviour. , 2001, The British journal of general practice : the journal of the Royal College of General Practitioners.

[36]  L. Whitworth,et al.  Recent Advances: Sacral Nerve Root Stimulation Using a Retrograde Method of Lead Insertion for the Treatment of Pelvic Pain due to Interstitial Cystitis , 1999, Neuromodulation : journal of the International Neuromodulation Society.

[37]  P. Wall,et al.  Pain mechanisms: a new theory. , 1965, Science.