Development of a 90-Minute Integrated Noninvasive Urinary Assay for Bladder Cancer Detection.

PURPOSE: Despite suboptimal sensitivity urine cytology is often performed as an adjunct to cystoscopy for bladder cancer diagnosis. We aimed to develop a noninvasive, fast molecular diagnostic test for bladder cancer detection with better sensitivity than urine cytology while maintaining adequate specificity. MATERIALS AND METHODS: Urine specimens were collected at 18 multinational sites from subjects prior to cystoscopy or tumor resection, and from healthy and other control subjects without evidence of bladder cancer. The levels of 10 urinary mRNAs were measured in a training cohort of 483 subjects and regression analysis was used to identify a 5-mRNA model to predict cancer status. The performance of the GeneXpert® Bladder Cancer Assay, an assay labeled for investigational use only to detect the 5 mRNAs ABL1, CRH, IGF2, ANXA10 and UPK1B, was evaluated in an independent test cohort of 450 participants. RESULTS: In the independent test cohort the assay ROC curve AUC was 0.87 (95% CI 0.81-0.92). At an example cutoff point of 0.4 overall sensitivity was 73% while specificity was 90% and 77% in the hematuria and surveillance patient populations, respectively. CONCLUSIONS: We developed a 90-minute, urine based test that is simple to perform for the detection of bladder cancer. The test can help guide physician decision making in the management of bladder cancer. Additional evaluation in a prospective study is needed to establish the clinical usefulness of this assay.

The transurethral suprapubic endo-cystostomy (T-SPeC): a novel suprapubic catheter insertion device.

BACKGROUND AND PURPOSE: Current methods of suprapubic cystostomy (SPC) catheter insertion may be difficult for patients in poor health and can result in significant morbidity and mortality. These include a highly invasive open procedure, as well as the use of the percutaneous trocar punch methods, commonly associated with short-term SPC. We present the first human experience with the Transurethral Suprapubic endo-Cystostomy (T-SPeC(®)) device, a novel disposable device used for introducing a suprapubic catheter via a retrourethral (inside-to-out) approach similar to the Lowsley technique. PATIENTS AND METHODS: Four men at St. Mary's General Hospital in Kitchener Ontario, Canada, received the T-SPeC device (model T7) under general anesthesia. RESULTS: Patients had no complications from catheterization using the T-SPeC T7 Surgical System. The mean surgical time of the four procedures was 9.7 minutes, with a range of 7.9 to 13.5 minutes, including instrument preparation and cystoscopy. All four procedures were highly accurate and rapid. There were no complications and minimal blood loss from the procedure. CONCLUSIONS: We found that the T-SPeC device allows for efficient and safe insertion of a suprapubic catheter in an outpatient setting and may be a useful addition to the urologic armamentarium. The T-SPeC Surgical System facilitates rapid and precise suprapubic catheter placement.

A multicenter, randomized, double-blind, parallel group pilot evaluation of the efficacy and safety of intravesical sodium chondroitin sulfate versus vehicle control in patients with interstitial cystitis/painful bladder syndrome.

OBJECTIVE: The goal of this pilot study was to gather information on differences between intravesical chondroitin sulfate and inactive vehicle control for treatment of interstitial cystitis/painful bladder syndrome (IC/PBS). METHODS: This was a prospective, randomized, double-blind, inactive vehicle-controlled, 12-week study (6-week treatment period, followed by a 6-week follow-up period) in patients with IC/PBS. Patients were randomized to weekly intravesical treatment with 2.0% sodium chondroitin sulfate in phosphate-buffered saline or intravesical vehicle control. Primary efficacy analysis compared responders (moderately or markedly improved) according to the 7-point Global Response Assessment. Secondary endpoints include questionnaires focused on symptoms and quality of life. RESULTS: Sixty-five evaluable patients were randomized. At the primary endpoint analysis (week 7), 22.6% of the vehicle control group were responders compared with 39.4% of the active therapy group (P = .15). There was no statistically significant difference for any of the secondary endpoints. Overall, 76.9% of the patients in the study reported at least 1 adverse event; most were mild or moderate, the majority associated with the vehicle control treatment. Nine nonserious intervention-related adverse events were reported in 3 patients in the vehicle control group compared with 2 in 1 patient in the active treatment group. CONCLUSION: The difference in treatment effect in this small underpowered study was not statistically significant, although twice as many patients reported a clinically significant benefit with intravesical chondroitin sulfate treatment compared with vehicle control treatment. This trial provides data required to design a well-powered randomized vehicle-controlled trial to determine the true efficacy of this potentially promising therapy.