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

NCT01043848 | Withdrawn

• 1 other identifier: EMSCI-NU-2/09
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Neurogenic Detrusor Overactivity; Spinal Cord Injury

Keywords

neurogenic detrusor overactivity; neuromodulation; spinal cord injury; pudendal nerve stimulation; videocystometry; neurophysiology; neuroplasticity

Outcome Measures

Primary Outcomes (1)

• Videocystometry

  week 4, 12, 26, 38, 52 after SCI

Secondary Outcomes (1)

• Neurophysiological measurements (NCV, BCR, SSR)

  week 2, 4, 12, 26, 38, 52 after SCI

Study Arms (3)

Early pudendal stimulation

EXPERIMENTAL

Subjects in this arm will start with the intervention within 2 weeks after SCI

Procedure: external electric pudendal nerve stimulation

Late pudendal stimulation

EXPERIMENTAL

Subjects in this arm will start with the intervention 12 weeks after SCI

Procedure: external electric pudendal nerve stimulation

Control

NO INTERVENTION

Subjects in this arm will be treated according to standard therapy but will receive no pudendal stimulation

Interventions

external electric pudendal nerve stimulation PROCEDURE

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).

Also known as: contic+, tic Medizintechnik GmbH, 46286 Dorsten, Germany

Early pudendal stimulation; Late pudendal stimulation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ulrich Mehnert: lead
• Institut Guttmann: collaborator
• Schweizerisches Paraplegikerzentrum Nottwil: collaborator
• BG Unfallklinik Murnau: collaborator
• Klinik für Paraplegiologie, Universitätsklinikum Heidelberg: collaborator

Study Sites (3)

Guttmann Institute

Badalona, Barcelona, 08916, Spain

Location

Schweizerisches Paraplegikerzentrum Nottwil

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ulrich Mehnert, MD

  University of Zurich

  PRINCIPAL INVESTIGATOR

• Martin Schubert, MD

  Balgrist University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive physician

Study Record Dates

• First Submitted: January 6, 2010
• First Posted: January 7, 2010
• Study Start: December 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

ES (1); CH (2)