eligible for neobladder reconstruction following radical cystectomy., Muscle-invasive bladder cancer (MIBC) patients
Conditions
Brief summary
Proportion of patients with a fatal event (death)., Proportion of patients with neobladder rejection., Proportion of patients for whom revision surgery was required., Proportion of patients who were free from the composite endpoint of death, neobladder rejection and need for revision surgery., Late post-surgical complications / Serious Adverse Events (SAEs)., Recurrent urinary tract infections (UTIs).
Detailed description
Degree of urinary continence., Presence of mucus in the urine., Incidence of urinary stone formation (urolithiasis)., Electrolyte disturbances and occurrence of metabolic acidosis., Health-Related Quality of Life (HRQoL), as assessed by the EORTC QLQ-C30 questionnaire score.
Interventions
DRUGaUroCell-Tx
Sponsors
Phosprint S.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with a fatal event (death)., Proportion of patients with neobladder rejection., Proportion of patients for whom revision surgery was required., Proportion of patients who were free from the composite endpoint of death, neobladder rejection and need for revision surgery., Late post-surgical complications / Serious Adverse Events (SAEs)., Recurrent urinary tract infections (UTIs). | — |
Secondary
| Measure | Time frame |
|---|---|
| Degree of urinary continence., Presence of mucus in the urine., Incidence of urinary stone formation (urolithiasis)., Electrolyte disturbances and occurrence of metabolic acidosis., Health-Related Quality of Life (HRQoL), as assessed by the EORTC QLQ-C30 questionnaire score. | — |
Outcome results
None listed