Table 2 Overview of bladder cancer RCTs with a PRO evaluation published between 2004 and 2018
Author | Intervention | Type of bladder cancer | Sample sizea | Main Clinical Outcome | PRO instrument used | Summary findings for main clinical outcome and PROb |
|---|---|---|---|---|---|---|
PRO primary endpoint | ||||||
 Marandola et al. 2005 [27] | Spinal anaesthesia with 10 mg of 0.5% hyperbaric bupivacine vs. 15 μg of sufentanil | Scheduled for TURBT | 62 | Motor and sensory blockages (primary) | Verbal analogue pain scale | • Bupivacine patients experienced more intense motor blockade • Statistical significance on PRO outcomes not reported |
 Ozyuvaci et al. 2005 [28] | General anaesthesia vs combined epidural and general anaesthesia for radical cystectomy | Scheduled for radical cystectomy | 50 | Intraoperative outcomes | Visual analogue scale | • Significant reduction of intraoperative blood loss for those in the combined group • Lower post-operative pain scores for the combined group |
 Gontero et al. 2013 [29] | Intravesical gemcitabine vs 1/3 dose BCG instillation | NMIBC | 120 | Recurrence and progression | EORT QLQ-C30 | • No difference in recurrence and progression • On univariate analysis, at T1, gemcitabine had better cognitive and emotional functioning and urinary symptom distress. At T2, gemcitabine had better cognitive functioning and less nausea and vomiting symptom distress |
 Johnson et al. 2013 [33] | 10 mg extended release oxybutynin daily or placebo 6 weeks prior to BCG treatment | BCG Naïve NMIBC | 50 | Adverse reactions and systemic symptoms | Self-reported urinary symptoms | • More urinary frequency and burning, fever and flu-like symptoms when receiving treatment • Worse urinary symptoms when receiving treatment |
 Karl et al. 2014 [30] | Early recovery vs conservative regimen after radical cystectomy | Scheduled for radical cystectomy | 101 | Postoperative morbidity, adverse events, mobility | EORTC QLQ-C30 | • Early recovery associated with lower rates of wound healing disorders, DVT and fever • Early recovery associated with improvements in most QLQ-C30 scales |
PRO secondary endpoint | ||||||
 Skinner et al. 2009 [31] Ahmadi et al. 2013 [32] | T pouch vs Studer pouch diversion after radical cystoprostatectomy | Scheduled for cystoprostatectomy | 295 | Renal function and anatomy at 3 years following surgery (primary) | Modified version of the Bladder Cancer Index | • No differences • Not reported |
 Koga et al. 2010 [26] | Maintenance vs observation following complete response after BCG | NMIBC | 53 | Efficacy of duration (primary) | EORTC QLQ-C30 | • Maintenance BCG associated with lower recurrence rate on univariate, but not multivariate, analyses • No difference in QoL |
Sabichi et al. 2011 [25] | Celecoxib vs. placebo | NMIBC | 146 | Time to recurrence (primary) | EORTC QLQ-C30 | • No effect on time to recurrence. • No difference in QoL |
 James et al. 2012 [24] | Radiotherapy with or without chemotherapy | MIBC | 360 | Survival free of locoregional disease (primary) | Not reported | • Locoregional disease-free survival was significantly better in the chemoradiotherapy group than in the radiotherapy group • PRO not reported |
 Kim et al. 2015 [20] | Glycopyrrolate vs atropine in combination with neostigmine after TURBT | Scheduled for TURBT | 74 | Incidence of catheter-related bladder discomfort postoperatively (primary) | Numerical rating scale | • Incidence of CRBD was significantly lower in the glycopyrrolate group than in the atropine group postoperatively • No difference in pain scores |
 Huang et al. 2015 [21] | Pirarubicin combined with hyaluronic acid vs pirarubicin alone after TURBT | Scheduled for TURBT | 127 | Recurrence (efficacy) (primary) | Visual analogue scale | • No difference in treatment efficacy • The VAS for bladder pain was significantly lower, at the end of the induction cycle, in the experimental group |
 Kim et al. 2015 [22] | Dexmedetomidine vs placebo during TURBT | Scheduled for TURBT | 109 | Incidence of catheter-related bladder discomfort postoperatively (primary) | Numerical rating scale | • Incidence of CRBD was significantly higher in the control group • The postoperative pain score was higher in the control group |
 Kim et al. 2016 [17] | Sevoflurane vs desflurane during TURBT | Scheduled for TURBT | 89 | Incidence of catheter-related bladder discomfort 24 h postoperatively (primary) | Numerical rating scale | • Sevoflurane was associated with less frequent postoperative CRBD • No difference in postoperative pain scores |
 Yokomizo et al. 2016 [18] | 80 mg BCG (standard) vs 40 mg BCG induction therapy | NMIBC or CIS | 166 | Non-inferiority with a null hypothesis of 15% decrease in complete response rate | EORT QLQ-C30 | • Noninferiority not proven. • Low dose BCG associated with higher quality of life |
 Khan et al. 2016 [19] | Laparoscopic radical cystectomy vs. robot-assisted radical cystectomy | Scheduled for cystectomy | 60 | 30- and 90-day complication rates | FACT-Bl | • 30-d complication rate higher in the open radical prostatectomy arm; but no differences at 90-d • No difference in QoL between both arms |
 Chung et al. 2017 [16] | Solifenacin vs standard care prior, during, and after TURBT | NMIBC | 134 | Incidence of catheter-related bladder discomfort (CRBD) at 1 and 2 h post TURBT (primary) | Visual analogue scale | • No difference in incidence rates • No difference in postoperative pain scores |
 Parekh et al. 2018 [23] | Robot-assisted radical cystectomy vs. open radical cystectomy | Scheduled for cystectomy | 302 | Progression-free survival at 2 years after surgery | Short Form-8 FACT-VCI | • Robotic cystectomy was non-inferior to open cystectomy for 2 years progression-free survival • No difference in QoL between both arms |