Finding studies
Finding studies
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Lead
Baylor College of Medicine
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.
Age
18–64
Sex
MALE
Healthy volunteers
Accepted
