Trial Outcomes & Findings for CISTO: Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer (NCT NCT03933826)
NCT ID: NCT03933826
Last Updated: 2025-11-04
Results Overview
Patient-reported quality of life is measured by the EORTC QLQ-C30 Physical Function scale. The scale ranges in score from 0 to 100, with higher function scores indicating better health. Scale score is calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100. Each scale requires responses for at least 50% of the items in order to be calculated.
ACTIVE_NOT_RECRUITING
570 participants
60 months after enrollment
2025-11-04
Participant Flow
Participant milestones
| Measure |
Patients who have selected bladder-sparing therapy
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
|
Patients who have selected radical cystectomy
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
|
|---|---|---|
|
Overall Study
STARTED
|
371
|
199
|
|
Overall Study
12-months from enrollment
|
303
|
174
|
|
Overall Study
COMPLETED
|
303
|
174
|
|
Overall Study
NOT COMPLETED
|
68
|
25
|
Reasons for withdrawal
| Measure |
Patients who have selected bladder-sparing therapy
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
|
Patients who have selected radical cystectomy
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
8
|
1
|
|
Overall Study
Death
|
19
|
11
|
|
Overall Study
Lost to Follow-up
|
41
|
13
|
Baseline Characteristics
CISTO: Comparison of Intravesical Therapy and Surgery as Treatment Options for Bladder Cancer
Baseline characteristics by cohort
| Measure |
Patients who have selected bladder-sparing therapy
n=371 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
|
Patients who have selected radical cystectomy
n=199 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
|
Total
n=570 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
293 Participants
n=15 Participants
|
160 Participants
n=161 Participants
|
453 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
39 Participants
n=15 Participants
|
17 Participants
n=161 Participants
|
56 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
332 Participants
n=15 Participants
|
182 Participants
n=161 Participants
|
514 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=15 Participants
|
4 Participants
n=161 Participants
|
10 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=15 Participants
|
8 Participants
n=161 Participants
|
26 Participants
n=100 Participants
|
|
Race (NIH/OMB)
White
|
341 Participants
n=15 Participants
|
184 Participants
n=161 Participants
|
525 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=15 Participants
|
2 Participants
n=161 Participants
|
6 Participants
n=100 Participants
|
|
Partner status
Partnered
|
288 Participants
n=15 Participants
|
170 Participants
n=161 Participants
|
458 Participants
n=100 Participants
|
|
Partner status
Unpartnered
|
83 Participants
n=15 Participants
|
29 Participants
n=161 Participants
|
112 Participants
n=100 Participants
|
|
Age, Continuous
|
72.4 years
STANDARD_DEVIATION 8.3 • n=15 Participants
|
69.6 years
STANDARD_DEVIATION 9.1 • n=161 Participants
|
71.4 years
STANDARD_DEVIATION 8.7 • n=100 Participants
|
|
Age, Customized
greater than or equal to 75 years
|
150 Participants
n=15 Participants
|
62 Participants
n=161 Participants
|
212 Participants
n=100 Participants
|
|
Age, Customized
Less than 75 years
|
221 Participants
n=15 Participants
|
137 Participants
n=161 Participants
|
358 Participants
n=100 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=15 Participants
|
39 Participants
n=161 Participants
|
117 Participants
n=100 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
2 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: 12 months after enrollmentPopulation: We performed tenfold multiple imputation (MICE R package) for all missing outcomes and covariates for analyses of all patient-reported outcomes.
The primary outcome of patient-reported quality of life is measured by the EORTC QLQ-C30 Physical Function scale. The scale ranges in score from 0 to 100, with higher function scores indicating better health. Scale score is calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100. Each scale requires responses for at least 50% of the items in order to be calculated.
Outcome measures
| Measure |
Patients who have selected radical cystectomy
n=174 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
|
Patients who have selected bladder-sparing therapy
n=304 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
|
|---|---|---|
|
Patient-reported Quality of Life as Measured by the Physical Function Scale of the European Organization for Research and Treatment of Cancer Quality-of-Life-Questionnaire-Core-30 (EORTC QLQ-C30)
|
86.5 score on a scale
Standard Deviation 17.5
|
85.0 score on a scale
Standard Deviation 18.9
|
PRIMARY outcome
Timeframe: 24 months after enrollmentPatient-reported quality of life is measured by the EORTC QLQ-C30 Physical Function scale. The scale ranges in score from 0 to 100, with higher function scores indicating better health. Scale score is calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100. Each scale requires responses for at least 50% of the items in order to be calculated.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 60 months after enrollmentPatient-reported quality of life is measured by the EORTC QLQ-C30 Physical Function scale. The scale ranges in score from 0 to 100, with higher function scores indicating better health. Scale score is calculated by transforming individual item scores into a 0 to 1 scale, taking the mean, and multiplying by 100. Each scale requires responses for at least 50% of the items in order to be calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after enrollmentPopulation: We imputed missing outcomes and covariates for TMLE analyses of this outcome. Therefore, all participants who enrolled in CISTO are included whether or not they completed that outcome. The mean and standard deviation for this outcome was calculated using only participants who completed this outcome (n = 292 and 166 for bladder-sparing therapy and radical cystectomy arms, respectively).
The evaluation of the effect of treatment choice on patient-reported urinary health, as measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate the two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.
Outcome measures
| Measure |
Patients who have selected radical cystectomy
n=166 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
|
Patients who have selected bladder-sparing therapy
n=292 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
|
|---|---|---|
|
Patient Self-reported Urinary Health as Measured by the Bladder Cancer Index Urinary Summary Score
|
83.8 score on a scale
Standard Deviation 14.2
|
85.3 score on a scale
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: 24 months after enrollmentThe evaluation of the effect of treatment choice on patient-reported urinary health, as measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate the two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 months after enrollmentThe evaluation of the effect of treatment choice on patient-reported urinary health, as measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate the two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after enrollmentPopulation: We imputed missing outcomes and covariates for TMLE analyses of this outcome. Therefore, all participants who enrolled in CISTO are included whether or not they completed that outcome. The mean and standard deviation for this outcome was calculated using only participants who completed this outcome (n = 238 and 143 for bladder-sparing therapy and radical cystectomy arms, respectively).
The evaluation of the effect of treatment choice on patient-reported sexual health, as measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.
Outcome measures
| Measure |
Patients who have selected radical cystectomy
n=143 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
|
Patients who have selected bladder-sparing therapy
n=238 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
|
|---|---|---|
|
Patient Self-reported Sexual Health as Measured by the Bladder Cancer Index Sexual Summary Score
|
32.6 score on a scale
Standard Deviation 20.1
|
47.1 score on a scale
Standard Deviation 25.7
|
SECONDARY outcome
Timeframe: 24 months after enrollmentThe evaluation of the effect of treatment choice on patient-reported sexual health, as measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 months after enrollmentThe evaluation of the effect of treatment choice on patient-reported sexual health, as measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after enrollmentPopulation: We imputed missing outcomes and covariates for TMLE analyses of this outcome. Therefore, all participants who enrolled in CISTO are included whether or not they completed that outcome. The mean and standard deviation for this outcome was calculated using only participants who completed this outcome (n = 293 and 166 for bladder-sparing therapy and radical cystectomy arms, respectively).
The evaluation of the effect of treatment choice on patient-reported bowel health, as measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.
Outcome measures
| Measure |
Patients who have selected radical cystectomy
n=166 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
|
Patients who have selected bladder-sparing therapy
n=293 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
|
|---|---|---|
|
Patient Self-reported Bowel Health as Measured by the Bladder Cancer Index Bowel Summary Score
|
77.2 score on a scale
Standard Deviation 10.8
|
80.1 score on a scale
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: 24 months after enrollmentThe evaluation of the effect of treatment choice on patient-reported bowel health, as measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 months after enrollmentThe evaluation of the effect of treatment choice on patient-reported bowel health, as measured by the Bladder Cancer Index (BCI). The BCI consists of 36 items, with 4- or 5-point Likert response scales, covering 3 primary domains: urinary, bowel, and sexual. For each domain a summary score is constructed from the items used to calculate two subscale scores (function and bother). Scores are calculated by transforming item responses into a 0 to 100 scale and calculating the mean of the standardized items. Higher scores indicate better health status. To calculate a score, a minimum of 80% completed items is required.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after enrollmentPopulation: We imputed missing outcomes and covariates for TMLE analyses of this outcome. Therefore, all participants who enrolled in CISTO are included whether or not they completed that outcome. The mean and standard deviation for this outcome was calculated using only participants who completed this outcome (n = 288 and 167 for bladder-sparing therapy and radical cystectomy arms, respectively).
The evaluation of the effect of treatment choice on patient-reported financial distress, as measured by the Comprehensive Score for Financial Toxicity (COST). The COST questionnaire consists of 11 items, each scored on a 5-point Likert scale from zero to four. After reversing some items as indicated in the scoring manual (by reversing the sign on the original zero to four score and adding four), all item response scores are summed into a single financial toxicity score ranging from 0 to 44, with higher scores indicating greater financial wellbeing. Each subscale requires responses for at least 50% of the items in that subscale in order to be calculated. Item nonresponse is accounted for by substituting the mean of the completed items in the subscale.
Outcome measures
| Measure |
Patients who have selected radical cystectomy
n=166 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
|
Patients who have selected bladder-sparing therapy
n=288 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
|
|---|---|---|
|
Patient Self-reported Financial Distress as Measured by the Comprehensive Score for Financial Toxicity (COST)
|
31.0 score on a scale
Standard Deviation 9.4
|
30.4 score on a scale
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: 24 months after enrollmentThe evaluation of the effect of treatment choice on patient-reported financial distress, as measured by the Comprehensive Score for Financial Toxicity (COST). The COST questionnaire consists of 11 items, each scored on a 5-point Likert scale from zero to four. After reversing some items as indicated in the scoring manual (by reversing the sign on the original zero to four score and adding four), all item response scores are summed into a single financial toxicity score ranging from 0 to 44, with higher scores indicating greater financial wellbeing. Each subscale requires responses for at least 50% of the items in that subscale in order to be calculated. Item nonresponse is accounted for by substituting the mean of the completed items in the subscale.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 months after enrollmentThe evaluation of the effect of treatment choice on patient-reported financial distress, as measured by the Comprehensive Score for Financial Toxicity (COST). The COST questionnaire consists of 11 items, each scored on a 5-point Likert scale from zero to four. After reversing some items as indicated in the scoring manual (by reversing the sign on the original zero to four score and adding four), all item response scores are summed into a single financial toxicity score ranging from 0 to 44, with higher scores indicating greater financial wellbeing. Each subscale requires responses for at least 50% of the items in that subscale in order to be calculated. Item nonresponse is accounted for by substituting the mean of the completed items in the subscale.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after enrollmentPopulation: We imputed missing outcomes and covariates for TMLE analyses of this outcome. Therefore, all participants who enrolled in CISTO are included whether or not they completed that outcome. The mean and standard deviation for this outcome was calculated using only participants who completed this outcome (n = 294 and 169 for bladder-sparing therapy and radical cystectomy arms, respectively).
The evaluation of patient-reported anxiety, as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
Outcome measures
| Measure |
Patients who have selected radical cystectomy
n=169 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
|
Patients who have selected bladder-sparing therapy
n=294 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
|
|---|---|---|
|
Patient-reported Anxiety as Measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a
|
48.8 T-score
Standard Deviation 8.9
|
50.0 T-score
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: 24 months after enrollmentThe evaluation of patient-reported anxiety, as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 months after enrollmentThe evaluation of patient-reported anxiety, as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after enrollmentPopulation: We imputed missing outcomes and covariates for TMLE analyses of this outcome. Therefore, all participants who enrolled in CISTO are included whether or not they completed that outcome. The mean and standard deviation for this outcome was calculated using only participants who completed this outcome (n = 294 and 169 for bladder-sparing therapy and radical cystectomy arms, respectively).
The evaluation of patient-reported depression, as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
Outcome measures
| Measure |
Patients who have selected radical cystectomy
n=169 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
|
Patients who have selected bladder-sparing therapy
n=294 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
|
|---|---|---|
|
Patient-reported Depression as Measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a
|
48.0 T-score
Standard Deviation 8.2
|
48.0 T-score
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: 24 months after enrollmentThe evaluation of patient-reported depression, as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 months after enrollmentThe evaluation of patient-reported depression, as measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a. Scores range from 0 to 100, with higher scores indicating greater symptoms. Scores are normalized to a mean of 50 and standard deviation of 10.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after enrollmentPopulation: We imputed missing outcomes and covariates for TMLE analyses of this outcome. Therefore, all participants who enrolled in CISTO are included whether or not they completed that outcome. The mean and standard deviation for this outcome was calculated using only participants who completed this outcome (n = 278 and 162 for bladder-sparing therapy and radical cystectomy arms, respectively).
The evaluation of patient-reported generic quality of life as measured by the EuroQoL EQ-5D-5L (EQ-5D). Scores range from 0 to 1, with higher scores indicating better health.
Outcome measures
| Measure |
Patients who have selected radical cystectomy
n=162 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
|
Patients who have selected bladder-sparing therapy
n=278 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
|
|---|---|---|
|
Patient-reported Generic Quality of Life as Measured by the EuroQoL EQ-5D-5L
|
0.86 score on a scale
Standard Deviation 0.13
|
0.84 score on a scale
Standard Deviation 0.14
|
SECONDARY outcome
Timeframe: 24 months after enrollmentThe evaluation of patient-reported generic quality of life as measured by the EuroQoL EQ-5D-5L (EQ-5D). Scores range from 0 to 1, with higher scores indicating better health.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 months after enrollmentThe evaluation of patient-reported generic quality of life as measured by the EuroQoL EQ-5D-5L (EQ-5D). Scores range from 0 to 1, with higher scores indicating better health.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollmentPopulation: All participants who had an electronic health record review or death record at least 12 months after the diagnosis of recurrent high-grade non-muscle invasive bladder cancer. Survival times were calculated from the date of recurrence to the event (metastasis or death). Censoring occurred at the last electronic health record review or death.
The evaluation of the effect of treatment choice on recurrence-free survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (recurrence or death). A recurrence was defined as any subsequent episode of high-grade bladder cancer in the bladder or elsewhere in the urinary tract (penile urethra, prostatic urethra, ureters, renal pelvis), either non-muscle or muscle invasive bladder cancer (for cystectomy arm this excludes any finding at cystectomy). Censoring occurred at the last electronic health record review or death.
Outcome measures
| Measure |
Patients who have selected radical cystectomy
n=192 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
|
Patients who have selected bladder-sparing therapy
n=356 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
|
|---|---|---|
|
Patient Recurrence-free Survival
|
176 Participants
|
226 Participants
|
SECONDARY outcome
Timeframe: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancerThe evaluation of the effect of treatment choice on recurrence-free survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (recurrence or death). A recurrence was defined as any subsequent episode of high-grade bladder cancer in the bladder or elsewhere in the urinary tract (penile urethra, prostatic urethra, ureters, renal pelvis), either non-muscle or muscle invasive bladder cancer (for cystectomy arm this excludes any finding at cystectomy). Censoring occurred at the last electronic health record review or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancerThe evaluation of the effect of treatment choice on recurrence-free survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (recurrence or death). A recurrence was defined as any subsequent episode of high-grade bladder cancer in the bladder or elsewhere in the urinary tract (penile urethra, prostatic urethra, ureters, renal pelvis), either non-muscle or muscle invasive bladder cancer (for cystectomy arm this excludes any finding at cystectomy). Censoring occurred at the last electronic health record review or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollmentPopulation: All participants who had an electronic health record review or death record at least 12 months after the diagnosis of recurrent high-grade non-muscle invasive bladder cancer. Survival times were calculated from the date of recurrence to the event (metastasis or death). Censoring occurred at the last electronic health record review or death.
The evaluation of the effect of treatment choice on metastasis-free survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (metastatis or death). A metastasis was defined as metastasis to distant lymph/nodes organs (pathologic or radiologic diagnosis of M+ disease) (for cystectomy arm this includes findings at cystectomy). Censoring occurred at the last electronic health record review or death.
Outcome measures
| Measure |
Patients who have selected radical cystectomy
n=192 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
|
Patients who have selected bladder-sparing therapy
n=349 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
|
|---|---|---|
|
Patient Metastasis-free Survival
|
178 Participants
|
330 Participants
|
SECONDARY outcome
Timeframe: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancerThe evaluation of the effect of treatment choice on metastasis-free survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (metastatis or death). A metastasis was defined as metastasis to distant lymph/nodes organs (pathologic or radiologic diagnosis of M+ disease) (for cystectomy arm this includes findings at cystectomy). Censoring occurred at the last electronic health record review or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancerThe evaluation of the effect of treatment choice on metastasis-free survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (metastatis or death). A metastasis was defined as metastasis to distant lymph/nodes organs (pathologic or radiologic diagnosis of M+ disease) (for cystectomy arm this includes findings at cystectomy). Censoring occurred at the last electronic health record review or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollmentPopulation: All participants who had an electronic health record review or death record at least 12 months after the diagnosis of recurrent high-grade non-muscle invasive bladder cancer. Survival times were calculated from the date of recurrence to the event (progression or death). Censoring occurred at the last electronic health record review or death.
The evaluation of the effect of treatment choice on metastasis-free survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (metastatis or death). A progression was defined as any subsequent episode of muscle-invasive (T2-T4) disease in the bladder or elsewhere in the urinary tract AND/OR locoregional (true pelvic/common iliac) nodal disease (N+) AND/OR distant metastasis (M+) (for cystectomy arm this includes findings at cystectomy). Censoring occurred at the last electronic health record review or death.
Outcome measures
| Measure |
Patients who have selected radical cystectomy
n=194 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
|
Patients who have selected bladder-sparing therapy
n=349 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
|
|---|---|---|
|
Patient Progression-free Survival
|
141 Participants
|
319 Participants
|
SECONDARY outcome
Timeframe: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancerThe evaluation of the effect of treatment choice on metastasis-free survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (metastatis or death). A progression was defined as any subsequent episode of muscle-invasive (T2-T4) disease in the bladder or elsewhere in the urinary tract AND/OR locoregional (true pelvic/common iliac) nodal disease (N+) AND/OR distant metastasis (M+) (for cystectomy arm this includes findings at cystectomy). Censoring occurred at the last electronic health record review or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancerThe evaluation of the effect of treatment choice on metastasis-free survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (metastatis or death). A progression was defined as any subsequent episode of muscle-invasive (T2-T4) disease in the bladder or elsewhere in the urinary tract AND/OR locoregional (true pelvic/common iliac) nodal disease (N+) AND/OR distant metastasis (M+) (for cystectomy arm this includes findings at cystectomy). Censoring occurred at the last electronic health record review or death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollmentPopulation: All participants who had an electronic health record review or death record at least 12 months after the diagnosis of recurrent high-grade non-muscle invasive bladder cancer. Survival times were calculated from the date of recurrence to the event (death from bladder cancer). Censoring occurred at the last electronic health record review or death from bladder cancer.
The evaluation of the effect of treatment choice on bladder cancer-specific survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (death from bladder cancer). Censoring occurred at the last electronic health record review or date of death from bladder cancer.
Outcome measures
| Measure |
Patients who have selected radical cystectomy
n=199 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
|
Patients who have selected bladder-sparing therapy
n=364 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
|
|---|---|---|
|
Patient Bladder Cancer-specific Survival
|
192 Participants
|
359 Participants
|
SECONDARY outcome
Timeframe: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancerThe evaluation of the effect of treatment choice on bladder cancer-specific survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (death from bladder cancer). Censoring occurred at the last electronic health record review or date of death from bladder cancer.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancerThe evaluation of the effect of treatment choice on bladder cancer-specific survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (death from bladder cancer). Censoring occurred at the last electronic health record review or date of death from bladder cancer.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollmentPopulation: All participants who had an electronic health record review or submitted a survey at least 12 months after the diagnosis of recurrent high-grade non-muscle invasive bladder cancer or had a death record at any time were included. Participants who did not have an electronic health record review or submit a survey at least 12 months after the diagnosis of recurrent high-grade non-muscle invasive bladder cancer and did not have a death record at any time were excluded.
The evaluation of the effect of treatment choice on overall survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (death). Censoring occurred at the last electronic health record review or date of death.
Outcome measures
| Measure |
Patients who have selected radical cystectomy
n=199 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
|
Patients who have selected bladder-sparing therapy
n=364 Participants
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
|
|---|---|---|
|
Patient Overall Survival
|
190 Participants
|
351 Participants
|
SECONDARY outcome
Timeframe: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancerThe evaluation of the effect of treatment choice on overall survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (death). Censoring occurred at the last electronic health record review or date of death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancerThe evaluation of the effect of treatment choice on overall survival. Survival times were calculated from the date of diagnosis of recurrent high-grade non-muscle invasive bladder cancer to the event (death). Censoring occurred at the last electronic health record review or date of death.
Outcome measures
Outcome data not reported
Adverse Events
Patients who have selected bladder-sparing therapy
Patients who have selected radical cystectomy
Serious adverse events
| Measure |
Patients who have selected bladder-sparing therapy
n=371 participants at risk
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
|
Patients who have selected radical cystectomy
n=199 participants at risk
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy (RC)
|
|---|---|---|
|
Infections and infestations
Abdominal infection
|
0.27%
1/371 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
1.0%
2/199 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
|
Infections and infestations
Lung infection
|
0.27%
1/371 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
0.50%
1/199 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/371 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
0.50%
1/199 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/371 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
1.0%
2/199 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
|
Infections and infestations
Sepsis
|
0.81%
3/371 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
1.5%
3/199 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/371 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
0.50%
1/199 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.54%
2/371 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
0.00%
0/199 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
|
Surgical and medical procedures
Postoperative hemorrhage
|
0.27%
1/371 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
0.00%
0/199 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
|
Cardiac disorders
Chest pain - cardiac
|
0.27%
1/371 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
0.00%
0/199 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
|
Surgical and medical procedures
Wound dehiscence
|
0.00%
0/371 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
1.0%
2/199 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
|
General disorders
|
4.9%
18/371 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
11.1%
22/199 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
Other adverse events
| Measure |
Patients who have selected bladder-sparing therapy
n=371 participants at risk
Patients with a diagnosis of recurrent high-grade NMIBC who have selected bladder-sparing therapy (BST)
|
Patients who have selected radical cystectomy
n=199 participants at risk
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy (RC)
|
|---|---|---|
|
Renal and urinary disorders
Hematuria
|
8.6%
32/371 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
3.0%
6/199 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
|
Renal and urinary disorders
Urinary tract infection (UTI)
|
11.1%
41/371 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
16.1%
32/199 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
|
Blood and lymphatic system disorders
Anemia
|
3.2%
12/371 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
20.1%
40/199 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
|
Gastrointestinal disorders
Nausea
|
3.5%
13/371 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
10.1%
20/199 • Time frame for all-cause mortality is 12 months post enrollment to match participant flow. Time frame for all other adverse events is 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment.
Adverse event reporting occurred systematically through regular investigator assessment and a standard questionnaire
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place