Quantitative and Qualitative Changes in Neural Efferent Receptors

This study has been withdrawn prior to enrollment.
(Study no longer being conducted.)
Sponsor:
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00472784
First received: May 11, 2007
Last updated: April 1, 2011
Last verified: April 2011
  Purpose

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.


Condition Phase
Spinal Cord Injury
Bladder Dysfunction
Phase 0

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • 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. [ Time Frame: 9 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 1998
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

Twenty-five (25) spinal cord injury patients, as part of their annual cystoscopic screening for squamous cell carcinoma, will be included in this study. Approximately twenty-five (25) control patients without spinal cord injury and already scheduled for cystoscopic procedures (transurethral resection of the prostate TURP for benign prostatic hyperplasia BPH, transurethral resection of low-grade superficial bladder tumor TURBT, or lithotripsy of urinary stones) will be included in this study. Enrollment of additional patients is necessary to increase the statistical power to demonstrate significant difference between the study and control groups. Preliminary results revealed that electron microscopy was accurate at differentiating neurogenic detrusor muscle from normal. There was a strong trend towards increased type I/type III collagen expression in SCI patients versus normal, but recruitment of more patients is necessary to demonstrate unequivocally a statistical difference.

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. Bladder mapping (diagram attached) will be performed to document specific areas biopsied. Tissue samples will be frozen for later RT-PCR analysis of collagen, smooth muscle, and efferent adrenergic receptor content and subtype. No anesthesia will be required in the SCI study patients. Control group patients will undergo anesthesia as indicated by their TURP or cystoscopic procedure.

Hemostasis will be achieved with a cautery electrode. Criteria for exclusion include active urinary tract infection identified by preoperative urinalysis. Patients with low-grade superficial bladder tumor, which has a classic cystoscopic appearance, is no longer excluded from the study since directed cold cup bladder biopsies at sites away from the visible tumor (obtained from the posterior, both lateral walls, as well as the trigone of the bladder) is now considered standard of care to rule out occult carcinoma-in-situ (CIS).

Prophylactic perioperative antibiotics will be employed. Patients will be followed in 1-2 weeks to evaluate their postoperative course.

Annual cystoscopy in spinal cord injured patients to screen for squamous cell carcinoma as well as preoperative cystoscopy in TURP, TURBT, and lithotripsy candidates is considered standard clinical care.

Selective bladder biopsies of normal appearing bladder mucosa and muscle are included as part of this study protocol.

Study patients will be given a preoperative dose of Rocephin 1 gm IM as well as a postoperative 3-day course of Cipro 500mg BD. Control patients will be given standard perioperative prophylactic/empiric therapy as indicated for their scheduled cystoscopic procedures.

Study patients will be scheduled for two visits. The first visit as part of their annual exam, to include cystoscopy, and bladder biopsies, will last approximately one hour. The second visit, two weeks later, will examine the patient's postoperative course. This visit will last approximately 15 minutes. Control patients will undergo cystoscopy and selected bladder biopsies preceding their already scheduled cystoscopic surgery.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Spinal cord injury Bladder dysfunction

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472784

Locations
United States, Texas
Baylor College of Medicine - Scott Department of Urology
Houston, Texas, United States, 77030
Michael E. DeBakey Veteran's Affairs Medcial Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Christopher P. Smith, M.D. Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Christopher P. Smith, M.D., Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00472784     History of Changes
Other Study ID Numbers: H-6079
Study First Received: May 11, 2007
Last Updated: April 1, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014