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

History of Changes

Purpose

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.

Condition	Intervention
Neurogenic Detrusor Overactivity Spinal Cord Injury	Procedure: external electric pudendal nerve stimulation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Therapeutic Effects of Early and Late Onset Peripheral Pudendal Neurostimulation on Bladder Function and Autonomic Neuroplasticity in SCI - a Controlled European Multicenter Study

Resource links provided by NLM:

MedlinePlus related topics: Spinal Cord Injuries

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:

Videocystometry [ Time Frame: week 4, 12, 26, 38, 52 after SCI ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Neurophysiological measurements (NCV, BCR, SSR) [ Time Frame: week 2, 4, 12, 26, 38, 52 after SCI ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	December 2009
Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Early pudendal stimulation Subjects in this arm will start with the intervention within 2 weeks after SCI	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: Late pudendal stimulation Subjects in this arm will start with the intervention 12 weeks after SCI	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
No Intervention: Control Subjects in this arm will be treated according to standard therapy but will receive no pudendal stimulation

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01043848

Locations

Spain
Guttmann Institute
Badalona, Barcelona, Spain, 08916
Switzerland
Schweizerisches Paraplegikerzentrum Nottwil
Nottwil, Luzern, Switzerland, 6207
Balgrist University Hospital
Zurich, Switzerland, 8008

Sponsors and Collaborators

University of Zurich

The Institut Guttmann

Schweizerisches Paraplegikerzentrum Nottwil

Neurourologie - Berufsgenossenschaftliche Unfallklinik Murnau

Klinik für Paraplegiologie, Universitätsklinikum Heidelberg

Investigators

Principal Investigator:	Ulrich Mehnert, MD	University of Zurich
Principal Investigator:	Martin Schubert, MD	Balgrist University Hospital

More Information

No publications provided

Responsible Party:	University of Zurich
ClinicalTrials.gov Identifier:	NCT01043848 History of Changes
Other Study ID Numbers:	EMSCI-NU-2/09
Study First Received:	January 6, 2010
Last Updated:	January 25, 2013
Health Authority:	Switzerland: Ethikkommission Switzerland: Swissmedic

Keywords provided by University of Zurich:

neurogenic detrusor overactivity
neuromodulation
spinal cord injury
pudendal nerve stimulation

videocystometry
neurophysiology
neuroplasticity

Additional relevant MeSH terms:

Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases

Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 23, 2013

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