ABSTRACT
INTRODUCTION AND OBJECTIVE: Patients with non-muscleinvasive bladder cancer (NMIBC) that recurs after treatment with intravesical Bacillus Calmette-Guerin (BCG) must weigh the risk of progression of bladder cancer and loss of a window of potential cure with medical therapy against the risk of morbidity and loss of quality of life (QOL) with radical cystectomy. The CISTO Study (NCT03933826) is a pragmatic, prospective observational cohort study comparing medical therapy (i.e., intravesical therapy or systemic immunotherapy) with radical cystectomy for recurrent highrisk NMIBC. Here we report on the design and progress of the CISTO Study. METHODS: 900 patients with recurrent high-risk NMIBC that has failed first-line BCG and who have chosen to undergo standard of care treatment will be enrolled. Patient stakeholders helped determine the primary outcome: 12-month patient-reported QOL using the EORTC QLQ-C30. Secondary outcomes include urinary and sexual function, decisional regret, financial distress, healthcare utilization, return to work/normal activities, progression, and recurrence-free, metastasis-free, and overall survival. Participants will be followed for up to 3 years. RESULTS: Enrollment is active at 32 sites across the US, including 23 university-based centers and 9 community sites. As of November 1, 2021, 173 participants have been enrolled, 104 of whom chose medical therapy and 69 of whom chose radical cystectomy. The completion rate for the primary outcome of QOL at 12 months is 94% (15 out of 16 participants to date). The inclusion of electronic consent and collection of PROs allowed recruitment and follow-up to continue remotely during the COVID-19 pandemic. Significant pandemic-related challenges have included slow study start-up at sites, staffing, periods of suspension, and delays in patients obtaining care. Strategies to address these challenges include improved methods for onboarding and training sites, all-site communication, confirming study eligibility, ing EHR data, and remote monitoring while adhering to the highest study standards. CONCLUSIONS: The CISTO Study will compare patient reported outcomes for those undergoing medical therapy with radical cystectomy for recurrent high-risk NMIBC. The CISTO Study has the potential to fill critical evidence gaps and provide for personalized, patient-centered care.
ABSTRACT
INTRODUCTION AND OBJECTIVE: The COVID-19 pandemic prompted a transition to telehealth in Urology. No study has analyzed urologic surgical outcomes among patients evaluated preoperatively via telehealth only. We compared surgical outcomes between patients who had telehealth only versus in-person preoperative visits prior to urologic surgery. METHODS: Retrospective single center review of all urologic surgeries from April-December 2020. Cases were classified based on whether patients visited preoperatively in person or via telehealth. Major exclusion criteria included having both preoperative in person and telehealth visits. Cases were stratified into four categories for analysis based on CPT coding: Upper Tract Endoscopic (UTE), Lower Tract Endoscopic (LTE), Major Abdominal (MA) (Open/ Laparoscopic/Robotic), and Lower Tract Reconstructive (LTR). Covariates of interest included age, sex, race, ASA status, and distance from hospital. Outcomes included need for blood products, complications, operative time, and length of stay (LOS). Complications were identified using reported morbidity and mortality data and organized based on the Clavien-Dindo scale;scores >2 were considered major complications. RESULTS: Table 1 displays demographic and outcomes of interest. 1,405 patients met inclusion criteria with 101 visits being telehealth only. There was no difference in sex, race, and ASA status. Telehealth patients were younger and lived farther away from the hospital and more likely to undergo UTE or MA surgeries compared to in person visits. There was no difference in perioperative complications or transfusion events between groups. Stratified by procedure type, there was no difference operative time or LOS between cohorts for UTE, MA, or LTE surgeries. LTR surgeries were associated with shorter operative times for telehealth patients, but no difference in LOS. CONCLUSIONS: Patients seen preoperatively by telehealth alone experienced no difference in complications or length of stay when undergoing urologic surgery, including major abdominal surgery. Despite limitations in selection bias and its retrospective nature, our study suggests that telehealth based preoperative evaluation is feasible and safe in appropriately selected patients undergoing urologic surgery.