Lumbar to Sacral Ventral Nerve Re-Routing
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|ClinicalTrials.gov Identifier: NCT00378664|
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : October 14, 2015
|Condition or disease||Intervention/treatment||Phase|
|Urinary Incontinence Spinal Cord Injury Spina Bifida||Procedure: lumbar to sacral ventral nerve re-routing procedure||Phase 2|
Spinal cord injury (SCI) and spina bifida is a source of irreversible injury to the spinal cord often resulting in paralysis and loss of sensation below the waist. The inability to urinate normally is a consequence of both conditions (neurogenic voiding dysfunction). In spina bifida and spinal cord injury, the nerve that controls the bladder and sphincter (the muscle that squeezes the bladder neck to prevent leaking) may no longer work properly resulting in patients who cannot urinate or are constantly wet.
Most patients will maintain high pressures in their bladder and these elevated pressures will eventually take its toll by causing recurrent urinary tract infections, backup of urine to the kidneys, and marked dilatation of possible further damage to the kidneys. Many patients eventually suffer from irreversible renal (kidney) damage, where dialysis or kidney transplant is the only way to sustain life.
Spinal bifida (present at birth) and SCI (occurs most often early in the fourth decade of life) predominately affect young individuals and longevity and quality of life may be greatly reduced by the presence of bladder, bowel, and sexual dysfunction. In the recent past, medications and catheters were the only way to help cord injured patients empty their bladders. Although clean intermittent catheterization (CIC) provides good maintenance results, medications can help conserve low bladder pressures, and antibiotics sustain an infection free urinary tract, these are difficult bladder management programs to uphold. They are expensive, time consuming, and outcomes are inconsistent.
A new surgical procedure has potential for treatment of spinal cord injuries/ spinal bifida. Recently, Dr. Chuan-Guo Xiao from China developed a surgical procedure of rewiring the nerves in the spinal cord to gain better control of urination and avoid complications of neurogenic bladder. The procedure reconnects live wires (nerves) to dead wires.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lumbar to Sacral Ventral Nerve Re-Routing|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
All enrollees are included in the intervention - lumbar to sacral ventral nerve re-routing procedure surgical nerve re-routing procedure.
Procedure: lumbar to sacral ventral nerve re-routing procedure
surgical nerve re-routing procedure
- Assess the level of improvement in voiding function after lumbar to sacral ventral nerve re-routing procedure in SCI and spina bifida patients. [ Time Frame: evaluated at 6 months and 1 year ]
- Assess the effect of lumbar to sacral ventral the nerve re-routing on bowel function in SCI and spina bifida patients [ Time Frame: evaluated at 6 month and 1 year visit ]
- Assess the effect of the lumbar to sacral ventral nerve re-routing on health related quality of life in SCI and spina bifida patients [ Time Frame: evaluate at 6 month and 1 year ]
- Assess the effect of the lumbar to sacral ventral nerve re-routing on ability to perform activities of daily living in SCI and spina bifida patients [ Time Frame: evaluate at 6 month and 1 year visit ]
- Assess the effect of the lumbar to sacral ventral nerve re-routing on sexual function in SCI patients 18 years of age and older [ Time Frame: evaluate at 6 months and 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378664
|Principal Investigator:||Kenneth M Peters, M.D.||William Beaumont Hospitals|