Evidenz urologische Indikationen InterStim sakrale Neuromodulation

Effektive Therapieoption bei Patienten mit überaktiver Blase oder nicht-obstruktiver Harnretention

Die Wirksamkeit der sakralen Neuromodulation wurde in zahlreichen Studien nachgewiesen. Dabei zeigte sich für die

überaktive Blase

eine signifikant höhere Wirksamkeit als mit medikamentöser Standardtherapie bereits bei milden Formen der überaktiven Blase^1,2
eine langfristige Wirksamkeit bei der Mehrzahl der Patienten über ca. 5 Jahre^3,4,5,6,7
eine signifikante und dauerhaft anhaltende Verbesserung der gesundheitsbezogenen Lebensqualität^1,8,9
kein klinisch relevanter Unterschied für den Patienten zwischen der Behandlung mit Onabotulinumtoxin A (Botox^® 200 Einheiten, doppelte zugelassene Dosis) oder Beckenbodenschrittmacher im Beobachtungszeitraum von 24 Monaten¹⁰
eine hohe Patientenzufriedenheit von über 84% mit über 90 % Patienten, die die Therapie weiterempfehlen würden^11,12

Harnretention

eine Normalisierung des Gefühls über die Blasenfüllung¹³
dass eine spontane Blasenentleerung wieder möglich ist^13,14,15
eine Verringerung der Anzahl an Katheterisierungen sowie eine Abnahme des katheterisierten Volumens^13,14,15
bei über 70 % der Patienten, die die Blase nicht ausreichend leeren können, ein langfristiger Therapieerfolg^{3,4,7,13,14,15}

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

Alle einblenden

Studien zu InterStim bei überaktiver Blase

pdf InSite 36-Monats-Ergebnisse SNM bei OAB (.pdf)

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Publikationen zur InSite Studie

Eine Zusammenfassung der Ergebnisse der InSite Studie finden Sie in der Broschüre "Wissenschaftlicher Fortschritt verbessert das Leben unserer Patienten - 3 Jahres-Ergebnisse der InSite Studie".

36 Monats-Daten: Three-year Follow-up Results of a Prospective, Multicenter Study in Overactive Bladder Subjects Treated With Sacral Neuromodulation.

"The 36-month follow-up data from the multicenter study demonstrate sustained safety, effectiveness, and improved QOL in subjects implanted with InterStim, without requiring failure of all medications."

Siegel S, Noblett K, Mangel J, Griebling TL, Sutherland SE, Bird ET, Comiter C, Culkin D, Bennett J, Zylstra S, Kan F, Thiery E. Urology. 2016 Aug;94:57-63.

Five-Year Follow up Results of a Prospective, Multicenter Study of Patients with Overactive Bladder Treated with Sacral Neuromodulation

"InterStim therapy provides a durable treatment effect from implantation to 5 years."

Siegel S, Noblett K, Mangel J, Bennett J, Griebling TL, Sutherland SE, Bird ET, Comiter C, Culkin D, Zylstra S, Kan F, Berg KC. J Urol. 2018 Jan;199(1):229-236.

12 Monats-Daten: Results of a prospective, multicenter study evaluating quality of life, safety, and efficacy of sacral neuromodulation at twelve months in subjects with symptoms of overactive bladder.

"This prospective, multicenter post-approval study evaluated the success rate of sacral neuromodulation (SNM) with the InterStim^® System at 12-months. ... The analysis which includes all implanted subjects with diary data at baseline and 12 months showed an OAB therapeutic success rate of 85% at 12 months."

Noblett K, Siegel S, Mangel J, Griebling TL, Sutherland SE, Bird ET, Comiter C, Culkin D, Bennett J, Zylstra S, Kan F, Berg KC. Neurourol Urodyn. 2016 Feb;35(2):246-51

6 Monats-Daten: Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim® Therapy compared to standard medical therapy at 6-months in subjects with mild symptoms of overactive bladder.

"This prospective, randomized, multicenter trial evaluated the 6-month success rate of sacral neuromodulation (SNM) with InterStim^® Therapy versus standard medical therapy (SMT) for overactive bladder (OAB) ... This study demonstrates superior objective and subjective success of SNM compared to SMT."

"This study suggests that after unsuccessful treatment with one or more anticholinergic medications, OAB subjects are more likely to benefit from SNM than an additional anticholinergic as a next step."

Steven S, Noblett K, Mangel J, Griebling TL, Sutherland SE, et al. Neurourol Urodyn. 2015 Mar;34(3):224-30. doi: 10.1002/nau.22544. Epub 2014 Jan 10.

Weitere Publikationen zur sakralen Neuromodulation bei überaktiver Blase

Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial

"Both treatments [sacral neuromodulation (SNM) and onabotulinumtoxinA (BTX)] offered sustainable UUI [urinary urge incontinence] improvement, and higher BTX dosing had low clean intermittent catheterization rates, but with UTI [urinary tract infection] risk. SNM revision/removal rates were low due to standardized lead placement with strict treatment response definitions."

"We found that both therapies had similar success in reducing UUI symptoms, and adverse events were low."

Amundsen CL, Komesu YM, Chermansky C, Gregory WT, Myers DL, Honeycutt EF, Vasavada SP, Nguyen JN, Wilson TS, Harvie HS, Wallace D; Pelvic Floor Disorders Network. Eur Urol. 2018 Jul;74(1):66-73.

Patient preferences for treating refractory overactive bladder in the UK.

"Preference was explored using direct questioning, comparing SNM, Botox, and PTNS ... Among the 127 (91 %) of patients who had experience with OAB medication only, most (≥80 %) were willing to try each of the three treatments; 57, 34, and 9 % most preferred PTNS, SNM, and Botox, respectively."

Hashim H, Beusterien K, Bridges JF, Amos K, Cardozo L. Int Urol Nephrol. 2015 Oct;47(10):1619-27

RESULTS OF SACRAL NEUROMODULATION THERAPY FOR URINARY VOIDING DYSFUNCTION: OUTCOMES OF A PROSPECTIVE, WORLDWIDE CLINICAL STUDY

"This long-term study demonstrates that InterStim^® Therapy is safe and effective for restoring voiding in appropriately selected cases refractory to other forms of treatment."

van Kerrebroeck PE, van Voskuilen AC, Heesakkers JP, et al. Journal of Urology. 2007;178:2029-2034.

Sakrale Neuromodulation bei refraktärer überaktiver Blase [Sacral neuromodulation for refractory overactive bladder].

"Die SNM ist eine international etablierte Behandlungsmethode für die refraktäre idiopathische OAB sowie weiterer Blasen- und Darmfunktionsstörungen."

"Die SNM kann erfolgreich bei „OAB wet“ und „OAB dry“ sowie bei Patienten mit oder ohne Detrusorüberaktivität eingesetzt werden."

"Der Wirkmechanismus der SNM scheint im Wesentlichen auf Modulation pathologischer Afferenzen betroffener Beckenbodenorgane zu beruhen."

"Das Verfahren ist leicht erlernbar und gut standardisiert."

"Die SNM ist mit niedriger Morbidität sicher."

van Ophoven A. Urologe A. 2018 Nov;57(11):1375-1388.

Studien zu InterStim bei Harnretention

RESULTS OF SACRAL NEUROMODULATION THERAPY FOR URINARY VOIDING DYSFUNCTION: OUTCOMES OF A PROSPECTIVE, WORLDWIDE CLINICAL STUDY

"This long-term study demonstrates that InterStim^® Therapy is safe and effective for restoring voiding in appropriately selected cases refractory to other forms of treatment."

van Kerrebroeck PE, van Voskuilen AC, Heesakkers JP, et al. Journal of Urology. 2007;178:2029-2034.

Efficacy of sacral nerve stimulation for urinary retention: results 18 months after implantation.

"...successful results were achieved in 83% of the implant group with retention compared to 9% of the control group at 6 months. ... Results of this prospective, randomized clinical study demonstrate that sacral nerve stimulation is effective for restoring voiding in patients with retention who are refractory to other forms of treatment."

Jonas U, Fowler CJ, Chancellor MB, Elhilali MM, Fall M, Gajewski JB, Grünewald V, Hassouna MM, Hombergh U, Janknegt R, van Kerrebroeck PE, Lylcklama a Nijeholt AA, Siegel SW, Schmidt RA. J Urol. 2001 Jan;165(1):15-9.

Sacral nerve stimulation for treatment of refractory urinary retention: long-term efficacy and durability.

"A retrospective study for all patients who underwent SNS with the InterStim device for refractory, nonobstructive urinary retention ... At a mean follow-up of 40 months, 85.7% of patients with refractory, nonobstructive urinary retention demonstrated greater than 50% improvement in symptoms with SNS. "

White WM, Dobmeyer-Dittrich C, Klein FA, Wallace LS. Urology 2008; 71:71-4.

Sacral neurostimulation for urinary retention: 10-year experience from one UK centre.

"Overall, 43 of 60 (72%) women were voiding spontaneously, with a mean postvoid residual volume of 100 mL; 30 (50%) no longer needed to use CISC. ... SNS has sustained long-term efficacy..."

Datta SN, Chaliha C, Singh A, Gonzales G, Mishra VC, Kavia RB, Kitchen N, Fowler CJ, Elneil S. BJU Int 2008; 101:192-6.

Optimizing the duration of assessment of stage-1 sacral neuromodulation in nonobstructive chronic urinary retention.

"By day 17, a cumulative percentage of 90% of patients had a normalized bladder sensation and 80% had commenced voiding. ... Stage-1 SNM may be left in situ for up to four weeks to ensure the maximum chance of restoring normal bladder function in this complex group of patients."

Elneil S, Abtahi B, Helal M, Digesu A, Gonzales G. Neuromodulation. 2014 Jan;17(1):66-70

Studien zur Programmierung und Follow-up

SACRAL NEUROMODULATION REPROGRAMMING: IS IT AN OFFICE BURDEN?

"Our objective was to evaluate the burden of sacral neuromodulation (SNM) reprogramming and the reasons for reprogramming, and to correlate these with the underlying diagnosis. . . . There was no correlation with number of reprogramming events and patient age, sex, reason for implantation, or diagnosis. These data suggest that the number of reprogramming episodes is small, and the majority is done as part of routine follow-up."

Burks FN, Ananais C, Lajiness MJ, et al. International Urogynecology Journal. 2008;19(8):1137-1140.

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.

Siegel S et al. Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim therapy compared to standard medical therapy at 6-months in subjects with mild symptoms of overactive bladder. Neurourol Urodyn. 2015 Mar;34(3):224-30.

Schmidt RA, Jonas U, Oleson KA, Janknegt RA, Hassouna MM, Siegel SW, van Kerrebroeck PE. Sacral nerve stimulation for treatment of refractory urinary urge incontinence. Sacral Nerve Stimulation Study Group. J Urol. 1999 Aug;162(2):352-7.

van Voskuilen AC, Oerlemans DJ, Weil EH, de Bie RA, van Kerrebroeck PE. Long term results of neuromodulation by sacral nerve stimulation for lower urinary tract symptoms: a retrospective single center study. Eur Urol. 2006 Feb;49(2):366-72.

⁴

van Kerrebroeck PE, van Voskuilen AC, Heesakkers JP, Lycklama á Nijholt AA, Siegel S, Jonas U, Fowler CJ, Fall M, Gajewski JB, Hassouna MM, Cappellano F, Elhilali MM, Milam DF, Das AK, Dijkema HE, van den Hombergh U. Results of sacral neuromodulation therapy for urinary voiding dysfunction: outcomes of a prospective, worldwide clinical study. J Urol. 2007 Nov;178(5):2029-34

⁵

Chartier-Kastler E, Ballanger P, Belas M, Biserte J, Corbel L, Gamé X, Grise P, Karsenty G, LeNormand L, Mauroy B, Pasquale J, Ruffion A, Rousseau T, Saussine C, Suberville M, Tollon C, et le club de neuromodulation del’Association francaise d’urologie. Neuromodulation sacrée avec le système InterStimTM : résultats du registre national francais. Prog Urol (2010),doi:10.1016/j.purol.2010.05.008

⁶

Groen J, Blok BF, Bosch JL. Sacral neuromodulation as treatment for refractory idiopathic urge urinary incontinence: 5-year results of a longitudinal study in 60 women. J Urol. 2011 Sep;186(3):954-9

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Peeters K, Sahai A, De Ridder D, Van Der Aa F. Long-term follow-up of sacral neuromodulation for lower urinary tract dysfunction. BJU Int. 2014 May;113(5):789-94

⁸

Siegel S, Noblett K, Mangel J, Griebling TL, Sutherland SE, Bird ET, Comiter C, Culkin D, Bennett J, Zylstra S, Kan F, Thiery E. Three-year Follow-up Results of a Prospective, Multicenter Study in Overactive Bladder Subjects Treated With Sacral Neuromodulation. Urology. 2016 Aug;94:57-63.

⁹

Siegel S et al. Five-Year Followup Results of a Prospective, Multicenter Study of Patients with Overactive Bladder Treated with Sacral Neuromodulation. J Urol. 2018 Jan;199(1):229-236.

¹⁰

Amundsen CL, Komesu YM, Chermansky C, Gregory WT, Myers DL, Honeycutt EF, Vasavada SP, Nguyen JN, Wilson TS, Harvie HS, Wallace D; Pelvic Floor Disorders Network. Two-Year Outcomes of Sacral Neuromodulation Versus OnabotulinumtoxinA for Refractory Urgency Urinary Incontinence: A Randomized Trial. Eur Urol. 2018 Jul;74(1):66-73

¹¹

Foster RT Sr, Anoia EJ, Webster GD, Amundsen CL. In patients undergoing neuromodulation for intractable urge incontinence a reduction in 24-hr pad weight after the initial test stimulation best predicts long-term patient satisfaction. Neurourol Urodyn. 2007;26(2):213-7

¹²

Leong RK, Marcelissen TA, Nieman FH, De Bie RA, Van Kerrebroeck PE, De Wachter SG. Satisfaction and patient experience with sacral neuromodulation: results of a single center sample survey. J Urol. 2011 Feb;185(2):588-92

¹³

Elneil S, Abtahi B, Helal M, Digesu A, Gonzales G. Optimizing the duration of assessment of stage-1 sacral neuromodulation in nonobstructive chronic urinary retention. Neuromodulation. 2014 Jan;17(1):66-70

¹⁴

Jonas U, Fowler CJ, Chancellor MB, Elhilali MM, Fall M, Gajewski JB, Grunewald V, Hassouna MM, Hombergh U, Janknegt R, van Kerrebroeck PE, Lylcklama a Nijeholt AA, Siegel SW, Schmidt RA. Efficacy of sacral nerve stimulation for urinary retention: results 18 months after implantation. J Urol 2001; 165:15-9

¹⁵

van Ophoven A. Neuromodulative Verfahren in Urologie und Proktologie, 1. Auflage, Uni-Med Verlag AG, 2013