Brief description of trial (Data source: BASEC)
Rückenmarksverletzungen führen meist zu Blasenfunktionsstörungen, welche sich häufig verschlechtern und mit einer Gefährdung der Nierenfunktion und Einschränkung der Lebensqualität einhergehen. Bei dieser schweiz-weiten Studie untersuchen wir die Wirkung der frühzeitigen TTNS auf Blasenfunktionsstörungen nach akuter Rückenmarksverletzung. Insgesamt werden 114 Patienten an den vier Schweizer Spezialkliniken für Rückenmarksverletzte, d.h. in Basel, Nottwil, Sion und Zürich, in die Studie eingeschlossen und nach dem Zufallsprinzip in 2 Gruppen eingeteilt: Bei 57 PatientInnen wird tatsächlich eine Therapie mit TTNS (VERUM) durchgeführt, bei 57 PatientInnen erfolgt nur scheinbar eine Therapie (Scheinbehandlung; SHAM (Placebo). Weder PatientInnen noch behandelnde ÄrztInnen kennen die Gruppen-Zuteilung, es handelt sich um eine doppel-blinde Studie. Die Therapie wird fünfmal wöchentlich für 30 Minuten während 6-9 Wochen durchgeführt. Die Dauer der Studie pro StudienteilnehmerIn beläuft sich auf 1 Jahr, wobei zu 4 festgelegten Zeitpunkten Vor- und Nachuntersuchungen stattfinden. Die Gesamtdauer der Studie beträgt 4 Jahre.
Health conditions investigated(Data source: BASEC)
Patienten, welche kürzlich (bis 40 Tage nach Verletzung) eine Rückenmarksverletzung auf Höhe der Hals- oder Brustwirbel erlitten haben.
Health conditions
(Data source: WHO)
Spinal Cord Injury, Acute
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
In dieser Studie wird die Wirkung der frühzeitigen elektrischen Stimulation des Schienbein-Nervs (transkutane tibiale Nervenstimulation (TTNS)) auf Blasenfunktionsstörungen nach akuter Rückenmarks-verletzung untersucht. Bei 57 PatientInnen wird tatsächlich eine Therapie mit TTNS (VERUM) durchgeführt, bei 57 PatientInnen erfolgt nur scheinbar eine Therapie (Scheinbehandlung; SHAM (Placebo). Die Therapie wird fünfmal wöchentlich für 30 Minuten während 6-9 Wochen durchgeführt.
Interventions
(Data source: WHO)
Device: VERUM TTNS;Device: SHAM TTNS
Criteria for participation in trial
(Data source: BASEC)
- > 18 Jahre
- Patienten mit akuter Rückenmarksverletzung auf Höhe der Hals- oder
Brustwirbel (bis 40 Tage nach Verletzung)
- Schriftliche Einverständniserklärung
Exclusion criteria
(Data source: BASEC)
- < 18 Jahre
- Personen mit Kontraindikationen für die Anwendung der elektrischen
Stimulation
- Aktuelle Behandlung mit Antimuskarinika oder Mirabegron
Inclusion/Exclusion Criteria
(Data source: WHO)
Gender: All
Maximum age: N/A
Minimum age: 18 Years
Inclusion Criteria:
- Age >18 years
- Patients with acute SCI (traumatic SCI and sudden onset (<7 days) non-traumatic SCI)
within 40 days after injury
- Patients with acute SCI at cervical or thoracic level
- Willing to take part and follow the requirements of the TASCI protocol (up to one year
after SCI)
- no percutaneous tibial nerve stimulation (PTNS)
- no functional electrical stimulation (FES), apart from upper limb FES
- no electrical muscle stimulation (EMS)
- Informed Consent
Exclusion Criteria:
- Contraindications to the investigational product
- DO with contractions greater than 40 cmH2O at a bladder filling volume of less than
500mL at baseline visit
- Treatment with antimuscarinics or with mirabegron
- Known or suspected non-adherence, drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems,
psychological disorders, dementia, etc. of the participant
- Participation in another study with investigational drug or product within the 30 days
preceding and during the present study
- Neuromodulation treatment for urological or bowel indication in the last six months or
ongoing
- Botulinum toxin injections in the detrusor and/or urethral sphincter in the last six
months
- Bilaterally absent tibial nerve compound muscle action potential (cMAP, amplitude <
1mV)
- Women who are pregnant or breast feeding
- Intention to become pregnant during the course of the study
- Individuals especially in need of protection (according to Research with Human
Subjects published by the Swiss Academy of Medical Sciences
[www.samw.ch/en/News/News.html])
- Enrolment of the investigator, his/her family members, employees and other dependent
persons
- Pre-existing or concomitant medical condition apart from SCI that might pose a safety
issue or would interfere with interpretation of study results or study conduct (e.g.
Parkinson's disease, neurodegenerative disorders including multiple sclerosis and
amyotrophic lateral sclerosis, urological malignancies)
-
Further information on trial
Recruitment status
Recruiting
Academic title
(Data source: WHO)
Transcutaneous Tibial Nerve Stimulation in Patients With Acute Spinal Cord Injury to Prevent Neurogenic Detrusor Overactivity: A Nationwide Randomised, Sham-controlled, Double-blind Clinical Trial
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
Phase
(Data source: WHO)
N/A
Primary end point
(Data source: WHO)
The occurrence of neurogenic DO jeopardizing the upper urinary tract
Secundary end point
(Data source: WHO)
Volumetric changes during urodynamics and their relation to clinical outcomes;Changes in bladder compliance [mL/cmH2O] during urodynamics and their relation to clinical outcomes;Pressure changes during urodynamics and their relation to clinical outcomes;Changes in maximum flow rate [mL/s] as assessed by urodynamics and their relation to clinical outcomes;Changes in vesicoureterorenal reflux (VUR) as assessed by videography during urodynamics and their relation to clinical outcomes;Changes in pelvic floor activity as assessed by electromyography (EMG) during urodynamics and their relation to clinical outcomes;Changes in bladder storage and voiding parameters and their relation to clinical outcomes;Changes in bowel diary parameters and their relation to clinical outcomes;Changes in International Prostate Symptom (IPSS) questionnaire and their relation to clinical outcomes;Changes in urinary symptoms as assessed by the Urinary Symptom Profile (USP) questionnaire and their relation to clinical outcomes;Changes in Qualiveen questionnaire scores and their relation to clinical outcomes;Changes in Female Sexual Function Index (FSFI) and their relation to clinical outcomes;Changes in International Index of Erectile Function (IIEF) and their relation to clinical outcomes;Changes in International Spinal Cord Society (ISCoS) Female / Male sexual function data sets and their relation to clinical outcomes;Changes in Neurogenic Bowel Dysfunction (NBD) score and their relation to clinical outcomes;Volumetric changes during rectal sensitivity testing and barostat assessment and their relation to clinical outcomes;Pressure changes during anorectal manometry and barostat assessment and their relation to clinical outcomes;Changes in rectal compliance [mL/cmH2O] during anorectal manometry and barostat assessment and their relation to clinical outcomes;Changes in defecatory disorder [Rao's classification] identified during anorectal manometry and their relation to clinical outcomes;Changes International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol;Changes in Lower Extremities Motor Scale (LEMS) from International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol;Changes in Upper Extremities Motor Scale (UEMS) from International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) protocol;Changes in Spinal Cord Independence Measure III (SCIM-III) and their relation to clinical outcomes;Changes in spasticity in the knee and elbow flexors and extensors from the Modified Ashworth Scale (MAS) assessment and their relation to clinical outcomes;Changes in spasticity in daily life as assessed by the Spinal Cord Injury Spasticity Evaluation Tool (SCI-SET) questionnaire and their relation to clinical outcomes;Changes in neurophysiology measurements of evoked potentials (EPs) as well as nerve conduction measurements and their relation to clinical outcomes;Changes in lower urinary tract (LUT) neurophysiology: Current perception thresholds (CPTs) and LUT sensory evoked potentials (LUTSEPs) with their relation to clinical outcomes;Changes in frequency power of surface electromyography (EMG) and electroencephalography (EEG) and their relation to clinical outcomes;Changes in EMG and EEG coherence measures and their relation to clinical outcomes;Changes in white and gray matter area in the lumbosacral enlargement (LSE) and their relation to clinical outcomes;Changes in white and gray matter area in upper cervical cord (at C2/C3) and their relation to clinical outcomes;Changes in white and gray matter volume of the conus medullaris (CM) and their relation to clinical outcomes;Changes in gray and white matter volume in the brain and their relation to clinical outcomes;Changes in fractional anisotropy (FA) in the brain and spinal cord and their relation to clinical outcomes;Changes in diffusivity in the brain and spinal cord and their relation to clinical outcomes;Changes in brain and spinal cord tissue microstructure and their relation to clinical outcomes;Expression profile of microRNA (miRNA) in urine and blood as well as their relation to clinical outcomes;Changes in inflammatory markers in bladder tissue, blood, and urine, as well as their relation to clinical outcomes;Changes in levels of neurotransmitters (neurotrophins) in blood, and urine, as well as their relation to clinical outcomes;Changes in the composition of urinary and stool microbiome and their relation to clinical outcomes;Changes in bladder tissue and their relation to clinical outcomes
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Basel, Nottwil, Sion, Zurich
Countries
(Data source: WHO)
Switzerland
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Dr. Martina Liechti
+41 44 510 72 05
martina.liechti@balgrist.ch
Contact for general information
(Data source: WHO)
Thomas M. Kessler, Prof. Dr. med.;Armin Curt, Prof. Dr. med.;Martin Brinkhof, Dr.;J?rgen Pannek, Prof. Dr. med.
University of Zurich;Balgrist University Hospital;Swiss Paraplegic Research, Nottwil;Swiss Paraplegic Centre
+41 44 386 39 07
thomas.kessler@balgrist.ch
Contact for scientific information
(Data source: WHO)
Thomas M. Kessler, Prof. Dr. med.;Armin Curt, Prof. Dr. med.;Martin Brinkhof, Dr.;J?rgen Pannek, Prof. Dr. med.
University of Zurich;Balgrist University Hospital;Swiss Paraplegic Research, Nottwil;Swiss Paraplegic Centre
+41 44 386 39 07
thomas.kessler@balgrist.ch
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
29.01.2020
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2019-00074
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