Spinal Cord Injury Clinical Trial
Official title:
Quantitative and Qualitative Changes in Neural Efferent Receptors, Collagen and Smooth Muscle Content in the Bladder, Following Spinal Cord Injury (SCI) in Humans
NCT number | NCT00472784 |
Other study ID # | H-6079 |
Secondary ID | |
Status | Withdrawn |
Phase | |
First received | |
Last updated | |
Start date | October 1998 |
Est. completion date | October 2010 |
Verified date | January 2020 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
OBJECTIVE: 1. To study tissues from spinal cord injured patients with noncompliant bladders
as well as neurologically intact patients with normal bladder compliance, analyzing both
quantitative and qualitative neural efferent receptors, collagen, and smooth muscle contents,
using RT-PCR and electron microscopy. 2. To explore the possible shift in bladder neural
architecture after SCI from beta to alpha-adrenergic receptors.
RESEARCH DESIGN: 25 spinal cord injury patients who underwent cystoscopic procedures will be
included in this study. 25 control patients without spinal cord injury and already scheduled
for urologic procedures will also be included in this study.
METHODOLOGY: Study patients will undergo flexible or rigid cystoscopy as well as selective
cold cup biopsies of the posterior and lateral walls, and trigonal area of the bladder.
Control patents will undergo cystoscopy and selected bladder biopsies preceding their
scheduled urologic procedures. Tissue samples will be frozen for later EM and RT-PCR analysis
of collagen, smooth muscle, and efferent adrenergic receptor content and subtype. Hemostasis
will be achieved with a cautery electrode. Criteria of exclusion include active urinary tract
infection identified by preoperative urinalysis, or the presence of suspicious lesions seen
during cystoscopy. Suspicious areas will be biopsied and the patient will be excluded from
the study.
Subjects will be given a preoperative dose of Rocephin 1g IM as well as a postoperative 3-day
course of Cipro 500 mg BID. Control patients will be given standard perioperative
prophylactic/empiric therapy as indicated for their urologic procedure. Patients will be
followed in 1-2 weeks to evaluate their postoperative course.
FINDINGS: Total number of subjects enrolled: 43. 12-03: To date we have not encountered any
problems with the study and health wise the subjects have done fine. No adverse events have
been reported. Preliminary Results: The tissue is currently being analyzed - mRNA by
microchip analysis and the data is still being worked on to look for correlations in genes up
or down regulation versus the morphological EM findings previously reported.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2010 |
Est. primary completion date | October 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: - Informed and consenting adult VA patients with either: 1. spinal cord injury and documented noncompliant bladders by urodynamics (n=20, 2. men with normal bladder compliance (n=5, >20cc/cm H20) scheduled for TURP or TURBT or lithotripsy Exclusion Criteria: - Patients with active urinary infections |
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine - Scott Department of Urology | Houston | Texas |
United States | Michael E. DeBakey Veteran's Affairs Medcial Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The tissue is currently being analyzed - mRNA by microchip analysis and the data is still being worked on to look for correlations in genes up or down regulation versus the morphological EM findings previously reported. | 9 years |
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