Somato-sensory Reflex Arch in Spinal Cord Injury - Effect on Clinical Outcome

NCT01241630 | Completed DMC

• 1 other identifier: M-20090113 - 2
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal cord injury (SCI) usually affects young people and causes severe bowel and bladder dysfunction. Recently, the concept of a surgically created somat-sensory reflex arch for bladder dysfunction in SCI has been introduced. The concept is promising, not just for bladder but also for bowel dysfunction. However, well designed studies need to be performed before recommending the procedure to a large number of patients worldwide. In this study we perform multidisciplinary studies providing necessary information about the clinical outcome of the somato-sensory reflex arch in adult SCI patients. The hypothesis is as follows:

1. 1.In a "western setting" the somato-sensory reflex arch can be created in adult SCI patients with only minor morbidity and complications.
2. 2.Somato-sensory reflex arch reduces bladder and bowel symptoms in SCI patients.

Conditions

Spinal Cord Injury

Keywords

Somato-sensory reflex arch; Spinal cord injury; Xiao Procedure

Outcome Measures

Primary Outcomes (1)

• Urodynamic function and bladder symptoms before and after somato-autonomic reflex arch in spinal cord injury patients

  Prospective study of urodynamic function and bladder symptoms before and after somato-autonomic reflex arch in spinal cord injury patients.

  2013 (anticipated)

Secondary Outcomes (3)

• Colorectal symptoms before and after somato-autonomic reflex arch in spinal cord injury patients

  2013 (anticipated)

• Colorectal transit times and rectal wall properties after somato-autonomic reflex arch in spinal cord injury patient

  2013 (anticipated)

• Effect of quality of Life after somato-autonomic reflex arch in spinal cord injury patient

  2013 (anticipated)

Interventions

Somatosensory reflex arch (Xiao Procedure) PROCEDURE

Cross over surgery. Proximal part of L5 Ventral root is anastomosed to distal part of ventral root of S2 or S3 producing a somato-sensory reflex arch

Also known as: Somato-sensory reflex arch, Artificial somato-sensory reflex arch

Eligibility Criteria

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

You may qualify if:

• years of age or above with motoric complete
• Spinal cord injury medullary level C4-L4
• Preserved Hamstring reflex (L5)
• Participation acceptance in verbal and writing

You may not qualify if:

• Respiratory dependent patient Baclofen pump Malignancy in the urinary tract, surgery on the urinary tract, urethral strictures Ileostomy, Colostomy or radiation towards the area Pregnancy, for men planning a pregnancy with their partner

Sponsors & Collaborators

• University of Aarhus: lead
• Lundbeck Foundation: collaborator

Study Sites (1)

Aarhus University Hospital

Aarhus, 8000, Denmark

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

• Klaus Krogh, MD,PhD, DmSc

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 16, 2010
• Study Start: November 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: May 12, 2014

Record last verified: 2012-10

Locations

DK (1)