Treatment of Neurogenic Detrusor Overactivity: Early Versus Late Pudendal Nerve Stimulation in Spinal Cord Injury (SCI) Patients

This study has suspended participant recruitment.
(Poor patient recruitment, necessary number of patients could not be included within the required time frame)
Sponsor:
Collaborators:
The Institut Guttmann
Schweizerisches Paraplegikerzentrum Nottwil
Neurourologie - Berufsgenossenschaftliche Unfallklinik Murnau
Klinik für Paraplegiologie, Universitätsklinikum Heidelberg
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01043848
First received: January 6, 2010
Last updated: January 25, 2013
Last verified: January 2010

January 6, 2010
January 25, 2013
December 2009
October 2012   (final data collection date for primary outcome measure)
Videocystometry [ Time Frame: week 4, 12, 26, 38, 52 after SCI ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01043848 on ClinicalTrials.gov Archive Site
Neurophysiological measurements (NCV, BCR, SSR) [ Time Frame: week 2, 4, 12, 26, 38, 52 after SCI ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment of Neurogenic Detrusor Overactivity: Early Versus Late Pudendal Nerve Stimulation in Spinal Cord Injury (SCI) Patients
Therapeutic Effects of Early and Late Onset Peripheral Pudendal Neurostimulation on Bladder Function and Autonomic Neuroplasticity in SCI - a Controlled European Multicenter Study

Background: Although a small group, special attention has to be given to lower urinary tract (LUT) dysfunctions in spinal cord injury (SCI) patients, as they also suffer under a loss of motor-sensory function and autonomic regulation next to the severe deficiencies in bladder and bowel control. Autonomic dysregulation linked with LUT dysfunction can cause autonomic dysreflexia with life threatening increases in blood pressure and there is still no concept for an early rehabilitation of bladder function after SCI.

Hypothesis: We assume that inadequate reorganization of nerve fibres in SCI is a reason for spastic bladder dysfunction and vegetative dysregulation and that this can be positively influenced by early neuromodulation. We hypothesized that bladder dysfunction as well as autonomic dysreflexia will be positively affected.

Specific aims: Evaluation, if external pudendal nerve stimulation (EPS) can positively influence LUT rehabilitation in SCI patients and if early initiation of stimulation is more effective compared to late initiation (after spinal shock).

Experimental design: Prospective multicentre study in 36 SCI patients (24 treatment subjects, 12 control subjects). EPS will be started either within 10 days after SCI (early stim group) or after cessation of spinal shock (late stim group). Effects on spastic bladder function and autonomic disinhibition will be assessed by urodynamics, vegetative tests, and by electrophysiological techniques.

Expected value: If early EPS is effective and complete SCI patients benefit from this intervention; and if early onset of EPS has better and longer lasting effects than late onset stimulation, the findings will be of utmost relevance not only for bladder function but also to alleviate adverse phenomena such as autonomic dysreflexia. Neurostimulation may bear the opportunity to early reshape maladaptive neuroplasticity. This would be proof of an effective modulation and promotion of neuroplasticity, thus opening up new treatment options in the field of paraplegiology.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Neurogenic Detrusor Overactivity
  • Spinal Cord Injury
Procedure: external electric pudendal nerve stimulation

intervention timing: twice daily for 20 minutes during 3 consecutive months.

intervention procedure: electrodes will be placed around the penile shaft (in males) or clips will be directly placed on the clitoris (in females).

intervention device: contic+

stimulation parameters: 10 Hz, 200μs pulse width, 10mA (or less, if too uncomfortable).

Other Name: contic+, tic Medizintechnik GmbH, 46286 Dorsten, Germany
  • Experimental: Early pudendal stimulation
    Subjects in this arm will start with the intervention within 2 weeks after SCI
    Intervention: Procedure: external electric pudendal nerve stimulation
  • Experimental: Late pudendal stimulation
    Subjects in this arm will start with the intervention 12 weeks after SCI
    Intervention: Procedure: external electric pudendal nerve stimulation
  • No Intervention: Control
    Subjects in this arm will be treated according to standard therapy but will receive no pudendal stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
36
Not Provided
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Single event traumatic or ischemic Para- or Tetraplegia
  • Complete SCI (ASIA A)
  • Lesion level between C4 and Th10
  • Performance of study treatment and assessments possible according to the study time schedule
  • Patient capable and willing of giving written informed consent

Exclusion Criteria:

  • Nontraumatic Para- or Tetraplegia (i.e. disc herniation, tumor, AV- Malformation, myelitis) exkl. single event ischemic incidences
  • Pre- known dementia or severe reduction of intelligence, leading to reduced capabilities of cooperation or giving consent
  • Peripheral Nerve lesions below the level of lesion (i.e. pudendal nerve impairment, cauda equina syndrome, pre- known Polyneuropathy)
  • Severe craniocerebral injury
  • Previous or planned intradetrusor injections of botulinum toxin
  • Previous or planned surgical therapy for neurogenic detrusor overactivity (e.g. bladder augmentation, Mitrofanoff, sphincter prothesis, sacral neuromodulation, deafferentation, sphincterotomy)
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain,   Switzerland
 
NCT01043848
EMSCI-NU-2/09
Not Provided
University of Zurich
University of Zurich
  • The Institut Guttmann
  • Schweizerisches Paraplegikerzentrum Nottwil
  • Neurourologie - Berufsgenossenschaftliche Unfallklinik Murnau
  • Klinik für Paraplegiologie, Universitätsklinikum Heidelberg
Principal Investigator: Ulrich Mehnert, MD University of Zurich
Principal Investigator: Martin Schubert, MD Balgrist University Hospital
University of Zurich
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP