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Quantitative and Qualitative Changes in Neural Efferent Receptors

NCT00472784 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2020-01-31

No results posted yet for this study

Summary

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.

Conditions

  • Spinal Cord Injury
  • Bladder Dysfunction

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Christopher P. Smith, M.D. · Baylor College of Medicine

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1998-10-31
Primary Completion
2010-10-31
Completion
2010-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00472784 on ClinicalTrials.gov