Evidenz proktologische Indikationen InterStim sakrale Neuromodulation

Hohe Wirksamkeit: Symptomlinderung und Lebensqualitätssteigerung durch InterStim

Die sakrale Neuromodulation mit InterStim zeigte in Studien zur

Stuhlinkontinenz
  • eine signifikant höhere Wirksamkeit als optimierte konservative Therapie1 
  • eine langfristige Wirksamkeit im Bezug auf Symptomlinderung und Lebensqualitätsverbesserung2,3,4,5,6
  • eine deutliche, signifikante Verbesserung der Lebensqualität3,7,8 
  • eine Wirksamkeit auch bei bestehenden Sphinkterdefekten9,10

Da jeder Patient anders auf eine Therapie reagiert können die individuellen Ergebnisse der Patienten von den in den Studien erzielten Resultaten abweichen. 

STUDIEN ZUR STUHLINKONTINENZ

Es wurden bereits eine Vielzahl an Studien - von einzelnen Fallbeschreibungen bis zu kontrolliert randomisierten Studien zur sakralen Neuromodulation mit dem InterStim - System publiziert. Eine kleine Auswahl davon finden Sie hier (in englischer Sprache):

ELECTRICAL STIMULATION OF SACRAL SPINAL NERVES FOR TREATMENT OF FAECAL INCONTINENCE

"In the field of urology the concept and technique of permanent electrical stimulation of the sacral spinal nerves are well established. We applied a similar method to faecal incontinence."

Matzel KE, Stadelmaier U, Hohenfellner M, Gall FP.  Lancet. 1995 Oct 28;346(8983):1124-7.

LONG-TERM DURABILITY OF SACRAL NERVE STIMULATION THERAPY FOR CHRONIC FECAL INCONTINENCE

"The aim was to assess the outcome of sacral nerve stimulation with the use of precise tools and data collection, focusing on the long-term durability of the therapy. Five-year data were analyzed...The therapeutic effect and improved quality of life for fecal incontinence is maintained 5 years after sacral nerve stimulation implantation and
beyond."

Hull T, Giese C., Wexner SD, Mellgren A., et al. Dis Colon Rectum. 2013 Feb;56(2):234-45.

SACRAL NERVE STIMULATION IS MORE EFFECTIVE THAN OPTIMAL MEDICAL THERAPY FOR SEVERE FECAL INCONTINENCE: A RANDOMIZED, CONTROLLED STUDY

"Patients (aged 39-86 years) with severe fecal incontinence were randomized to have sacral nerve stimulation or best supportive therapy, which consisted of pelvic floor exercises, bulking agent, and dietary manipulation....In the sacral nerve stimulation group, there was a significant (P < 0.0001) improvement in fecal incontinence quality of life index in all four domains. By contrast, there was no significant improvement in fecal continence and the fecal incontinence quality of life scores in the control group."

Tjandra JJ, Chan MKY, Yeh CH, Murray-Green C. Dis Colon Rectum. 2008 May;51(5):494-502.

EFFICACY OF SACRAL NERVE STIMULATION FOR FECAL INCONTINENCE: RESULTS OF A MULTICENTER DOUBLE-BLIND CROSSOVER STUDY

"This is the first double-blind multicenter study examining the effectiveness of sacral nerve stimulation in a significant number of fecally incontinent patients....The significant improvement in FI during the ON versus OFF period indicated that the clinical benefit of sacral nerve stimulation was not due to placebo."

Leroi AM, Parc Y, Lehur PA, et al. Annals of Surgery, 2005

Sacral  nerve modulation for fecal incontinence: results of a prospective single-center randomized crossover study.

"In light of the need for evidence-based medicine, our trial has shown that the clinical benefit derived from SNM is unlikely to result from a placebo effect and lends further support to the observational data demonstrating the effectiveness of SNM at bringing continence to patients with FI."

Kahlke V, Topic H, Peleikis HG, Jongen J. Dis Colon Rectum. 2015 Feb;58(2):235-40.

Changing  paradigm of sacral neuromodulation and external anal sphincter repair for faecal incontinence in specialist centres

"The paradigm of surgical intervention for FI has changed with increasing use of SNM."

Ong K, Bordeianou L, Brunner M, Buntzen S, Collie MHS, Hanly A, Hunt CW, Matzel KE, O'Connell PR, Rydningen M, Savitt L, Totaro A, Vaizey CJ, Maeda Y.  Colorectal Dis. 2021 Mar;23(3):710-715.

Publikationen zur Implantationstechnik und Programmierung

Sacral Neuromodulation: Standardized Electrode Placement Technique

“Standardization of electrode placement may ensure close electrode proximity to the target nerve providing a higher likelihood for optimal effect with less energy consumption (better battery longevity), more programming options with more electrode contacts close to the nerve and reduced likelihood of side-effects.”

Matzel KE, Chartier-Kastler E, Knowles CH, Lehur PA, Muñoz-Duyos A, Ratto C, Rydningen MB, Sørensen M, van Kerrebroeck P, de Wachter S.  Neuromodulation. 2017 Dec;20(8):816-824.

Programming Algorithms for Sacral Neuromodulation: Clinical Practice and Evidence - Recommendations for Day-to-Day Practice

"Programming of SNM therapy is not complex. There are few programming settings that seem beneficial or significantly impact patient outcomes. Only four basic electrode configurations could be identified according to four different options to define the cathode. In a majority of patients, the proposed stimulation parameters will allow a satisfactory improvement for long periods of time."

Lehur PA, Sørensen M, Dudding TC, Knowles CH, de Wachter S, Engelberg S, Matzel KE; European SNM Expert Group. Neuromodulation. 2020 Dec;23(8):1121-1129.b [open access: https://onlinelibrary.wiley.com/doi/epdf/10.1111/ner.13117]

Reprogramming Sacral Neuromodulation for Sub-Optimal Outcomes: Evidence and Recommendations for Clinical Practice

"Reprogramming aims to further improve patient symptoms or ensure a comfortable delivery of the therapy. Initial changes of electrode configuration and adjustment of stimulation parameters can be performed at home to avoid unnecessary hospital visits. A logical and stepwise approach to reprogramming can improve the outcome of therapy and restore patient satisfaction.”

Dudding TC, Lehur PA, Sørensen M, Engelberg S, Bertapelle MP, Chartier-Kastler E, Everaert K, Van Kerrebroeck P, Knowles CH, Lundby L, Matzel KE, Muñoz-Duyos A, Rydningen MB, de Wachter S. Neuromodulation. 2021 Jul 15. doi: 10.1111/ner.13494. Epub ahead of print. [open access: https://onlinelibrary.wiley.com/doi/epdf/10.1111/ner.13494]

Wikistim

Neuromodulation ist eines der aufstrebenden medizinischen Gebiete mit viel Forschungs- und Publikationsmöglichkeiten. Die kostenfreie, unabhängige und spendenfinanzierte Plattform „WIKISTIM“ sammelt Informationen zu allen Publikationen rund um die Neuromodulation und hat zum Ziel, zu jeder Veröffentlichung ein Abstract der Ergebnisse zur Verfügung zu stellen.

Eine ideale Plattform also, um sich über die Vielzahl an Publikationen zur sakralen Neuromodulation zu informieren - es sind bereits über 800 Publikationen zur SNM (SNS, sakrale Neurostimulation) gelistet. 

1

Tjandra JJ, Chan MKY, Yeh CH et al. Sacral Nerve Stimulation is more Effective than Optimal Medical Therapy for Severe Fecal Incontinence: A Randomized, Controlled Study. Dis Colon Rectum. 2008; 51:494-502

2

Altomare DF, Giuratrabocchetta S, Knowles CH, Muñoz Duyos A, Robert-Yap J, Matzel KE; European SNS Outcome Study Group. Long-term outcomes of sacral nerve stimulation for faecal incontinence. Br J Surg. 2015 Mar;102(4):407-15. doi: 10.1002/bjs.9740. Epub 2015 Feb 2

3

Hull T, Giese C, Wexner SD, et al. Long-term Durability of Sacral Nerve Stimulation Therapy for Chronic Fecal Incontinence. Dis Colon Rectum. 2013; 56:234-245

4

Thin NN, Horrocks EJ, Hotouras A, et al. Systematic review of the clinical effectiveness of neuromodulation in the treatment of faecal incontinence. Br J Surg. 2013; 100:1430-1447

5

Uludağ O, Melenhorst J, Koch SM, van Gemert WG, Dejong CH, Baeten CG. Sacral neuromodulation: long-term outcome and quality of life in patients with faecal incontinence. Colorectal Dis. 2011 Oct;13(10):1162-6. doi: 10.1111/j.1463-1318.2010.02447.x

6

Matzel KE, Lux P, Heuer S, et al. Sacral nerve stimulation for faecal incontinence: long-term outcome. Colorectal Disease. 2009; 11:636-641

7

Mellgren A, Wexner SD, Coller Ja, et al. SNS Study Group. Long-term efficacy and safety of sacral nerve stimulation for fecal incontinence. Dis Colon Rectum. 2011; 54:1065-1075

8

Devroede G, Giese C, Wexner SD, Mellgren A, Coller JA, Madoff RD, Hull T, Stromberg K, Iyer S; SNS Study Group. Quality of life is markedly improved in patients with fecal incontinence after sacral nerve stimulation. Female Pelvic Med Reconstr Surg. 2012 Mar-Apr;18(2):103-12.

9

Chan MKY, Tjandra JJ. Sacral Nerve Stimulation for Fecal Incontinence: External Anal Sphincter Defect vs. Intact Anal Sphincter. Dis Colon Rectum. 2008; 51(7):1015-24

10

ICI: INCONTINENCE 6th Edition 2017. Eds: Abrams, Cardozo, Wagg, Wein (6th International Consultation on Incontinence, Tokyo, September 2016).