Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472784
Status:
WITHDRAWN
Last Update Posted:
2020-01-31
First Post:
2007-05-11
Brief Title:
Quantitative and Qualitative Changes in Neural Efferent Receptors
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study no longer being conducted
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 prophylacticempiric 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
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 prophylacticempiric 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
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 Itype 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 prophylacticempiric 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 patients postoperative course This visit will last approximately 15 minutes Control patients will undergo cystoscopy and selected bladder biopsies preceding their already scheduled cystoscopic surgery
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 prophylacticempiric 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 patients postoperative course This visit will last approximately 15 minutes Control patients will undergo cystoscopy and selected bladder biopsies preceding their already scheduled cystoscopic surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None