An observational study in Bladder Cancer, Cancer of the Bladder, Recurrent and Non-muscle Invasive Bladder Cancer, sponsored by University of Washington. Active, not recruiting at 36 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-12.
Sponsored by University of Washington · Observational
Bladder cancer is the most common urinary tract cancer and the 5th most common cancer in the US (1). Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery as Treatment Options (CISTO) for Bladder Cancer Study has the potential to fill these critical evidence gaps, change care pathways for the management of non-muscle-invasive bladder cancer (NMIBC), and provide for personalized, patient-centered care. The purpose of CISTO is to conduct a large prospective study that directly compares the impact of medical management versus bladder removal in recurrent high-grade NMIBC patients with Bacillus Calmette-Guerin (BCG) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).
Most bladder cancer patients (74%) present with NMIBC where the cancer is limited to the lining or support layer of the bladder. High-grade NMIBC is treated initially with endoscopic resection and intravesical immunotherapy, followed by bladder instillations of BCG. Most patients with high-risk, high-grade NMIBC are able to retain their bladders and avoid more invasive treatments. However, 24-61% of patients will have their cancers recur within 12 months of treatment with BCG (BCG failures), and they have limited treatment options. National guidelines recommend consideration between two alternatives: additional medical management and radical cystectomy (removal of the bladder). Selecting between these options involves weighing the risk of progression of bladder cancer and loss of a window of potential cure versus the risk of morbidity and loss of quality of life (QOL) with bladder removal. This complex decision-making engages patients and their caregivers, who may be impacted by the urinary, sexual, and bowel dysfunctions that can occur with NMIBC treatment.
The investigators will evaluate this research question on a large scale in real world practice settings including academic and community-based practices and examine patient-centered outcomes. The investigators have engaged stakeholders with diverse perspectives relevant to this research question, including patients, caregivers, national patient advocacy organizations, national medical specialty organizations, guideline developers, health care payers, and industry. By engaging broad expertise relevant to this research question, the investigators will ensure that the study results will help NMIBC patients whose cancer recurs after BCG treatment make more informed decisions that improve the health outcomes that are important to them.
CISTO is an observational study that will not affect the treatment that patients chose. Patient surveys will occur at study entry and at follow-up assessments for up to four years. There will also be a qualitative sub-study that will include interviews of approximately 50 patients and 25 caregivers recruited from the observational cohort study.
294 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 126 are open to participants now.
This study's enrollment of 570 is above the median of 300 across 49 observational studies indexed under Non-Muscle Invasive Bladder Neoplasms.
Browse Non-Muscle Invasive Bladder Neoplasms studies →University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
Compared within Non-Muscle Invasive Bladder Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urinary Bladder Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Patients with a diagnosis of recurrent high-grade NMIBC who are considering second-line treatment will be approached for participation in this observational study in addition to their caregivers. Enrollment at each site will aim for a 2:1 ratio of participants selecting bladder-sparing therapy to radical cystectomy in order to ensure adequate enrollment of radical cystectomy patients. There will also be a qualitative sub-study that will include interviews of 50 patients and 25 caregivers recruited from the observational cohort study.
Patient Eligibility, Inclusion Criteria:
Presenting with high-grade NMIBC established by anatomic pathology as tumor stage classification Tis, Ta, or T1, and with:
Patient Eligibility, Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with a diagnosis of recurrent high-grade NMIBC who have selected radical cystectomy
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)
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.
Time frame: 12 months after enrollment
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)
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.
Time frame: 24 months after enrollment
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)
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.
Time frame: 60 months after enrollment
Patient Self-reported Urinary Health as Measured by the Bladder Cancer Index Urinary Summary Score
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.
Time frame: 12 months after enrollment
Patient Self-reported Urinary Health as Measured by the Bladder Cancer Index Urinary Summary Score
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.
Time frame: 24 months after enrollment
Patient Self-reported Urinary Health as Measured by the Bladder Cancer Index Urinary Summary Score
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.
Time frame: 60 months after enrollment
Patient Self-reported Sexual Health as Measured by the Bladder Cancer Index Sexual Summary Score
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.
Time frame: 12 months after enrollment
Patient Self-reported Sexual Health as Measured by the Bladder Cancer Index Sexual Summary Score
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.
Time frame: 24 months after enrollment
Patient Self-reported Sexual Health as Measured by the Bladder Cancer Index Sexual Summary Score
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.
Time frame: 60 months after enrollment
Patient Self-reported Bowel Health as Measured by the Bladder Cancer Index Bowel Summary Score
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.
Time frame: 12 months after enrollment
Patient Self-reported Bowel Health as Measured by the Bladder Cancer Index Bowel Summary Score
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.
Time frame: 24 months after enrollment
Patient Self-reported Bowel Health as Measured by the Bladder Cancer Index Bowel Summary Score
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.
Time frame: 60 months after enrollment
Patient Self-reported Financial Distress as Measured by the Comprehensive Score for Financial Toxicity (COST)
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.
Time frame: 12 months after enrollment
Patient Self-reported Financial Distress as Measured by the Comprehensive Score for Financial Toxicity (COST)
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.
Time frame: 24 months after enrollment
Patient Self-reported Financial Distress as Measured by the Comprehensive Score for Financial Toxicity (COST)
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.
Time frame: 60 months after enrollment
Patient-reported Anxiety as Measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a
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.
Time frame: 12 months after enrollment
Patient-reported Anxiety as Measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a
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.
Time frame: 24 months after enrollment
Patient-reported Anxiety as Measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a
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.
Time frame: 60 months after enrollment
Patient-reported Depression as Measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a
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.
Time frame: 12 months after enrollment
Patient-reported Depression as Measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a
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.
Time frame: 24 months after enrollment
Patient-reported Depression as Measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a
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.
Time frame: 60 months after enrollment
Patient-reported Generic Quality of Life as Measured by the EuroQoL EQ-5D-5L
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.
Time frame: 12 months after enrollment
Patient-reported Generic Quality of Life as Measured by the EuroQoL EQ-5D-5L
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.
Time frame: 24 months after enrollment
Patient-reported Generic Quality of Life as Measured by the EuroQoL EQ-5D-5L
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.
Time frame: 60 months after enrollment
Patient Recurrence-free Survival
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.
Time frame: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment
Patient Recurrence-free Survival
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.
Time frame: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Recurrence-free Survival
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.
Time frame: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Metastasis-free Survival
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.
Time frame: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment
Patient Metastasis-free Survival
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.
Time frame: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Metastasis-free Survival
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.
Time frame: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Progression-free Survival
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.
Time frame: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment
Patient Progression-free Survival
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.
Time frame: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Progression-free Survival
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.
Time frame: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Bladder Cancer-specific Survival
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.
Time frame: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment
Patient Bladder Cancer-specific Survival
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.
Time frame: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Bladder Cancer-specific Survival
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.
Time frame: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Overall Survival
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.
Time frame: 12 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer, up to 12 months post enrollment
Patient Overall Survival
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.
Time frame: 24 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
Patient Overall Survival
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.
Time frame: 60 months after diagnosis of recurrent high-grade non-muscle invasive bladder cancer
| Milestone | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy |
|---|---|---|
| Started | 371 | 199 |
| 12-months from enrollment | 303 | 174 |
| Completed | 303 | 174 |
| Not completed | 68 | 25 |
| Withdrew: Withdrawal by subject | 8 | 1 |
| Withdrew: Death | 19 | 11 |
| Withdrew: Lost to follow-up | 41 | 13 |
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.
| score on a scale | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy |
|---|---|---|
| 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) | 85.0 ± 18.9 | 86.5 ± 17.5 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
| score on a scale | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy |
|---|---|---|
| Patient Self-reported Urinary Health as Measured by the Bladder Cancer Index Urinary Summary Score | 85.3 ± 16.7 | 83.8 ± 14.2 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
| score on a scale | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy |
|---|---|---|
| Patient Self-reported Sexual Health as Measured by the Bladder Cancer Index Sexual Summary Score | 47.1 ± 25.7 | 32.6 ± 20.1 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
| score on a scale | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy |
|---|---|---|
| Patient Self-reported Bowel Health as Measured by the Bladder Cancer Index Bowel Summary Score | 80.1 ± 9.5 | 77.2 ± 10.8 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
| score on a scale | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy |
|---|---|---|
| Patient Self-reported Financial Distress as Measured by the Comprehensive Score for Financial Toxicity (COST) | 30.4 ± 9.9 | 31.0 ± 9.4 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
| T-score | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy |
|---|---|---|
| Patient-reported Anxiety as Measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Anxiety 4a | 50.0 ± 8.9 | 48.8 ± 8.9 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
| T-score | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy |
|---|---|---|
| Patient-reported Depression as Measured by the Patient Reported Outcome Measurement Information System (PROMIS) Short Form v1.0 - Depression 4a | 48.0 ± 8.3 | 48.0 ± 8.2 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
| score on a scale | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy |
|---|---|---|
| Patient-reported Generic Quality of Life as Measured by the EuroQoL EQ-5D-5L | 0.84 ± 0.14 | 0.86 ± 0.13 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
| Participants | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy |
|---|---|---|
| Patient Recurrence-free Survival | 226 | 176 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
| Participants | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy |
|---|---|---|
| Patient Metastasis-free Survival | 330 | 178 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
| Participants | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy |
|---|---|---|
| Patient Progression-free Survival | 319 | 141 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
| Participants | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy |
|---|---|---|
| Patient Bladder Cancer-specific Survival | 359 | 192 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
| Participants | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy |
|---|---|---|
| Patient Overall Survival | 351 | 190 |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over 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.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Who Have Selected Bladder-sparing Therapy | 19/371 (5.1%) | 25/371 (6.7%) | 77/371 (20.8%) |
| Patients Who Have Selected Radical Cystectomy | 11/199 (5.5%) | 29/199 (14.6%) | 73/199 (36.7%) |
| Event | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy |
|---|---|---|
| SepsisInfections and infestations | 3/371 | 3/199 |
| Abdominal infectionInfections and infestations | 1/371 | 2/199 |
| Small intestinal obstructionGastrointestinal disorders | 0/371 | 2/199 |
| Wound dehiscenceSurgical and medical procedures | 0/371 | 2/199 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 2/371 | 0/199 |
| Lung infectionInfections and infestations | 1/371 | 1/199 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/371 | 1/199 |
| Urinary tract obstructionRenal and urinary disorders | 0/371 | 1/199 |
| Postoperative hemorrhageSurgical and medical procedures | 1/371 | 0/199 |
| Chest pain - cardiacCardiac disorders | 1/371 | 0/199 |
| Event | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy |
|---|---|---|
| AnemiaBlood and lymphatic system disorders | 12/371 | 40/199 |
| Urinary tract infection (UTI)Renal and urinary disorders | 41/371 | 32/199 |
| NauseaGastrointestinal disorders | 13/371 | 20/199 |
| HematuriaRenal and urinary disorders | 32/371 | 6/199 |
| Age, Continuous(years) | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy | Total |
|---|---|---|---|
| Mean | 72.4 ± 8.3 | 69.6 ± 9.1 | 71.4 ± 8.7 |
| Age, Customized(Participants) | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy | Total |
|---|---|---|---|
| greater than or equal to 75 years | 150 | 62 | 212 |
| Less than 75 years | 221 | 137 | 358 |
| Sex: Female, Male(Participants) | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy | Total |
|---|---|---|---|
| Female | 78 | 39 | 117 |
| Male | 293 | 160 | 453 |
| Ethnicity (NIH/OMB)(Participants) | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy | Total |
|---|---|---|---|
| Hispanic or Latino | 39 | 17 | 56 |
| Not Hispanic or Latino | 332 | 182 | 514 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 6 | 4 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 18 | 8 | 26 |
| White | 341 | 184 | 525 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 4 | 2 | 6 |
| Partner status(Participants) | Patients Who Have Selected Bladder-sparing Therapy | Patients Who Have Selected Radical Cystectomy | Total |
|---|---|---|---|
| Partnered | 288 | 170 | 458 |
| Unpartnered | 83 | 29 | 112 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — De-identified study data will be shared according to the PCORI policy for data management and data sharing.
Supporting information: Study protocol, Statistical analysis plan
Time frame: The PCORI-designated repository will make the data available for third-party requests when PCORI makes the Final Research Report available on the PCORI website pursuant to PCORI's Process for Peer Review of Primary Research and Public Release of Research Findings. Data will be available in perpetuity.
Access criteria: Individual investigators or teams of investigators seeking access to data from PCORI-funded studies must complete and submit a data request form to the PCORI-designated repository.
Ran from Jul 2019 to primary completion in Jan 2025, 66 months.
Results were first posted in Nov 2025, 9 months after primary completion.
Of 29 observational studies under Non-Muscle Invasive Bladder Neoplasms, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 30. This study's 66 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Non-Muscle Invasive Bladder Neoplasms →