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Spinal Cord InjuryNCT00472784

Quantitative and Qualitative Changes in Neural Efferent Receptors

An observational study of Spinal Cord Injury and Bladder Dysfunction, run by Baylor College of Medicine at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years, men onlyHealthy volunteers can take part
Conditions the study is for
Spinal Cord Injury, Bladder Dysfunction
How many people
0 participants
Where
2 sitesUnited States
Study dates
Oct 1998to Oct 2010
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Study population: Spinal cord injury Bladder dysfunction

Who may be able to join

  • Informed and consenting adult VA patients with either:
  • spinal cord injury and documented noncompliant bladders by urodynamics (n=20,
  • men with normal bladder compliance (n=5, >20cc/cm H20) scheduled for TURP or TURBT or lithotripsy

Who cannot join

  • Patients with active urinary infections

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Baylor College of Medicine - Scott Department of Urology

    Houston, Texas, 77030

  • Michael E. DeBakey Veteran's Affairs Medcial Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

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.

Read more

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.

Read the 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.

Medical subject headings
Spinal Cord Injuries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 9 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2007 (estimated)
  2. Study startOct 1998
  3. Primary completionOct 2010
  4. Study completionOct 2010

Why it stopped: Study no longer being conducted.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00472784
Sponsor's protocol ID
H-6079
Status last verified
Jan 2020
First submitted
11 May 2007
Last updated
31 Jan 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Spinal Cord Injury and Bladder Dysfunction, run by Baylor College of Medicine at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.

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