Ignite Creation Date:
2024-05-06 @ 1:29 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01824329
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2013-03-31
Brief Title:
Prostate Capsule Sparing Cystectomy and Nerve-sparing Radical Cystoprostatectomy in Men With Bladder Cancer
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Prospective Phase II Randomized Trial of Prostate Capsule Sparing Cystectomy and Nerve-sparing Radical Cystoprostatectomy in Men With Bladder Cancer
Status:
COMPLETED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARC
Brief Summary:
Bladder cancer is the 4th most common cancer amongst men If bladder cancer invades the muscle of the bladder or fails local treatments surgical removal of the bladder cystectomy with creation of a new bladder from intestine is required However standard cystectomy affects urinary function and sexual function The investigators are evaluating two modifications to cystectomy to determine to what extent they preserve urinary and sexual function
Detailed Description:
Radical cystoprostatectomy RCP is the standard treatment of muscle invasive and refractory high grade superficial bladder cancer RCP involves the removal of the bladder and prostate While this is an effective treatment for patients with organ confined disease almost all men following RCP are impotent due to resection of the neurovascular bundles that control erectile dysfunction While neobladders new bladders formed out of detubularized bowel connected to the native urethra allow patients to void normally many of these patients have difficulty with urinary incontinence Two modifications have been developed to improve the functional outcomes of this surgery Nerve sparing cystectomy NSC attempts to spare the cavernosal nerves that travel immediately adjacent to the lateral prostate and are routinely divided during a standard RCP Published series of NSC have shown improved preservation of sexual function and less urinary incontinence without compromising cancer control Another alternative prostate capsule sparing cystectomy PCSC removes the adenoma and prostatic urethra along with the urinary bladder but leaves in situ the prostatic capsule and subsequently the surrounding neurovascular bundle Several retrospective series have demonstrated preservation of sexual function and improved urinary continence compared to standard RCP and neobladder A concern with PCSC is that prostate or urothelial cancer invading the prostate could be left behind with preservation of the prostate capsule Most reported series in which patients were screened with digital rectal exam prostate and prostatic urethral biopsy and PSA blood testing could identify patients at risk for having prostate or urothelial cancer in the prostate capsule preoperatively to recommend an alternative approach Therefore both NSC and PCSC appear to offer better urinary and sexual function in properly selected patients over conventional RCP in retrospective series However these procedures have not been evaluated prospectively in a randomized fashion Our intent is to evaluate the functional outcomes of PCSC and NSC with orthotopic neobladder in terms of urinary and sexual function using the bladder cancer index a validated quality of life instrument and determine the surgical margin status and complications of the two surgical techniques
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