IncobotulinumtoxinA versus onabotulinumtoxinA intradetrusor injections in patients with neurogenic detrusor overactivity incontinence: a double-blind, randomized, non-inferiority trial.

BACKGROUND: A randomized, double-blind, non-inferiority clinical study was performed on the efficacy and tolerability of IncobotulinumtoxinA (Incobot/A) vs. OnabotulinumtoxinA (OnabotA) intradetrusor injections in patients with refractory neurogenic detrusor overactivity incontinence performing intermittent catheterization. METHODS: Sixty-four patients with spinal cord injury (SCI) or multiple sclerosis were randomized to receive 30 intradetrusor injections of Incobot/A or OnabotA 200 U; 28 patients in incobotulinumtoxinA group and 29 in onabotulinumtoxinA group completed the study. Primary outcome measure was the non-inferior variation from baseline in daily urinary incontinence episodes (week 12), with a non-inferiority margin of one episode/day. Secondary outcomes measures were changes in Incontinence- Quality of Life questionnaire, Visual Analog Scale Score (bother of symptoms on Quality of Life), urodynamic parameters, occurrence of adverse effects and related costs (week 12). RESULTS: At week 12, mean value of difference in urinary incontinence episodes/day between the two groups was -0.2 (95% two-sided CI: -1; 0.7); the difference in incontinence episodes/day between the two groups was -0.4 with a higher limit of one-sided 95% CI of 0.2 episodes/day which was much lower than the non-inferiority margin of one episode/day. Total score and subscores of Incontinence- Quality of Life questionnaire, Visual Analog Scale scores and urodynamics did not show differences between the two groups. Adverse effects were similar for both treatments, with urinary tract infection being the most frequent, localised effect. Minor costs were observed following Incobot/A. CONCLUSIONS: In patients with refractory neurogenic incontinence due to SCI or multiple sclerosis, incobotulinumtoxinA was not inferior to onabotulinumtoxinA in improving clinical and urodynamic findings in the short-term follow-up, with comparable adverse effects but minor costs.

Increased risk of transurethral and suprapubic catheter self-extraction in COVID-19 patients: real-life experience.

INTRODUCTION: This study evaluated the prevalence of transurethral catheter self-removal in critically-ill COVID-19 non-sedated adult patients compared with non-COVID-19 controls. METHODS: COVID-19 patients who self-extracted transurethral or suprapubic catheters needing a urological intervention were prospectively included (group A). Demographic data, medical and nursing records, comorbidities and nervous system symptoms were evaluated. Agitation, anxiety and delirium were assessed by the Richmond Agitation and Sedation Scale (RASS). The control group B were non-COVID-19 patients who self-extracted transurethral/suprapubic catheter in a urology unit (subgroup B1) and geriatric unit (subgroup B2), requiring a urological intervention in the same period. RESULTS: 37 men and 11 women were enrolled in group A. Mean RASS score was 3.1 ± 1.8. There were 5 patients in subgroup B1 and 11 in subgroup B2. Chronic comorbidities were more frequent in group B than the COVID-19 group (P<0.01). COVID-19 patients had a significant difference in RASS score (P<0.006) and catheter self-extraction events (P<0.001). Complications caused by traumatic catheter extractions (severe urethrorrhagia, longer hospital stay) were greater in COVID-19 patients. CONCLUSION: This is the first study focusing on the prevalence and complications of catheter self-removal in COVID-19 patients. An increased prevalence of urological complications due to agitation and delirium related to COVID-19 has been demonstrated-the neurological sequelae of COVID-19 must be considered during hospitalisation.

Continuing care for patients affected by urologic chronic pelvic pain in the era of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic.

AIMS: Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) pandemic poses a challenge to treatment of patients with urologic chronic pelvic pain (UCPP), who are at risk to be postponed in the priority of care. We investigated pain, catastrophizing, and psychological status in UCPP patients during SARS-CoV-2 by means of Skype telephone calls. METHODS: A total of 28 UCPP patients underwent Skype video consultations. Pain intensity was assessed with Pain Numerical Rating Scale (PNRS). Pain Catastrophizing Scale (PCS) and Depression Anxiety Stress Scales (DASS-21) were used to assess catastrophizing and psychological status. RESULTS: During SARS-CoV-2, UCPP patients showed higher intensity of pain than before (mean ± SD PNRS score: 7.25 ± 0.9 vs. 5.4 ± 0.7; p < .0001), with pain exacerbation in 75%; they showed higher PCS and DASS-21 scores as compared to before the pandemic (mean ± SD PCS total score: 32.4 ± 1.2 vs. 23.7 ± 3.5; mean ± SD DASS-21 total score: 42.03 ± 4.5 vs. 34.4 ± 2.2; p < .001 and p < .001, respectively). CONCLUSION: During SARS-CoV-2 pandemic UCPP patients presented with high intensity of pain, marked catastrophizing thoughts and severe alteration of the psychological status. These observations impose the need not to postpone assessment and treatment of these patients during the pandemic. Remote visits with video telephone calls are a simple way of continuing care in UCPP patients.