A Phase 2 interventional study of Prostate capsule sparing cystectomy and Nerve sparing cystectomy in Bladder Cancer and Transitional Cell Carcinoma of the Bladder, sponsored by University of Michigan. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-19.
Sponsored by University of Michigan · Phase 2, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
Prostate capsule sparing cystectomy involves removing the entire bladder.
Procedure: Prostate capsule sparing cystectomy
Nerve sparing cystectomy involves removal of the whole bladder and the entire prostate.
Procedure: Nerve sparing cystectomy
Removes the adenoma and prostatic urethra along with the urinary bladder, but leaves in situ the prostatic capsule and subsequently the surrounding neurovascular bundle.
Attempts to spare the cavernosal nerves that travel immediately adjacent to the lateral prostate and are routinely divided during a standard RCP.
Post-operative urinary function
Assess post-operative urinary function using the bladder cancer index (BCI) in patients randomized to either prostate capsule sparing cystectomy (PCSC) or nerve sparing radical cystoprostatectomy (NSC).
Time frame: 7 years
Bladder cancer control
Determine bladder cancer control with PCSC compared to NSC as measured by margin status and time to disease recurrence.
Time frame: 7 years
Sexual function
Determine sexual function after PCSC and NSC using the BCI.
Time frame: 7 Years
Adverse event rates
Determine adverse event rates after PCSC and NSC.
Time frame: 7 years
Peri-operative differences
Determine peri-operative differences between PCSC and NSC in terms of operative time, estimated blood loss, length of hospital stay, and time to catheter removal.
Time frame: 7 years
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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University of Michigan