Efficacy and Safety of AbobotulinumtoxinA in Patients with Neurogenic Detrusor Overactivity Incontinence Performing Regular Clean Intermittent Catheterization: Pooled Results from Two Phase 3 Randomized Studies (CONTENT1 and CONTENT2)

Kennelly, Michael; Cruz, Francisco; Herschorn, Sender; Abrams, Paul; Önem, Kadir; Solomonov, Viktor Kibanov; Coz, Elena Del Rosario Figueroa; Manu-Marin, A.; Giannantoni, Antonella; Thompson, Catherine; Vilain, Claire; Volteau, Magali; Denys, P.

doi:10.1016/j.eururo.2022.03.010

Cited by 25 publications

(18 citation statements)

References 20 publications

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“…Improvements in symptoms with aboBoNT‐A in the present study were reflected in urodynamic parameters, and thus bladder function, in a similar manner for the SCI and MS groups, consistent with results of onaBoNT‐A treatment in patients with NDOI, with improvements observed to similar extents 17 . This trend was confirmed across urodynamic endpoints with onaBoNT‐A, consistent with the pooled analysis of previous aboBoNT‐A phase III studies 18 . However, the majority of the MS group were not performing CIC before treatment in onaBoNT‐A studies, so significant increases in post‐void residual urine, urinary retention, and instigation of CIC were observed, all of which were associated with an increased incidence of UTIs 17 .…”

Section: Discussionsupporting

confidence: 89%

“…Full details of methodology have been published 18 . Briefly, CONTENT1 and CONTENT2 were phase III multicenter, randomized, double‐blind, parallel‐group, placebo‐controlled studies in adults with SCI or MS and NDOI uncontrolled with oral medication and requiring regular CIC.…”

Section: Methodsmentioning

confidence: 99%

“…Exclusion criteria included previous or current tumor or malignancy affecting the spine or any other nonstable cause of SCI, medications that affect neuromuscular transmission, and unstable MS (which can affect urinary symptoms and therefore interfere with treatment effect measures). Full details of eligibility criteria have been published 18 …”

Section: Methodsmentioning

confidence: 99%

“…A logistic regression model was used for analysis of the proportion of patients with no IDCs at Week 6. Details of statistical analyses have been published 18 . No imputations were performed for missing data.…”

Section: Methodsmentioning

confidence: 99%

“…However, patients were not required to regularly perform CIC; the risks of new onset CIC, urinary retention and urinary tract infection (UTI) were found to be higher following onaBoNT‐A treatment in patients with MS compared with SCI; and the majority of the SCI group were also already performing CIC 17 . The clinical program presented here assessed abobotulinumtoxinA (aboBoNT‐A; Dysport®, Ipsen Ltd.) in patients with NDOI due to SCI or MS who regularly performed CIC (CONTENT1 [NCT02660138] and CONTENT2 [NCT02660359]) 18 . Given the difference in patient populations between studies of onaBoNT‐A and aboBoNT‐A with respect to CIC status, a pooled analysis of data from the CONTENT studies was performed to evaluate whether etiology of NDOI had an impact on efficacy and safety of aboBoNT‐A, since it has already been shown that aboBoNT‐A 600 or 800 U was well tolerated, and improved bladder storage symptoms, quality of life (QoL), and urodynamic parameters in the overall population 18 …”

Section: Introductionmentioning

confidence: 99%

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AbobotulinumtoxinA is effective in patients with urinary incontinence due to neurogenic detrusor overactivity regardless of spinal cord injury or multiple sclerosis etiology: Pooled analysis of two phase III randomized studies (CONTENT1 and CONTENT2)

Denys

Castaño

Nunes

et al. 2022

Neurourology and Urodynamics

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Background Neurogenic detrusor overactivity incontinence (NDOI) is often inadequately managed with oral therapy. Objective To assess efficacy and safety of abobotulinumtoxinA (aboBoNT‐A; Dysport®; Ipsen Ltd.) according to etiology of NDOI. Design, Setting, and Participants Two phase III, randomized, double‐blind studies (CONTENT1 [NCT02660138] conducted in Asia, Europe and North America; CONTENT2 [NCT02660359] conducted in the Americas, Asia, Europe and Oceania) both included patients with spinal cord injury (SCI) or multiple sclerosis (MS), with inadequately managed NDOI, regularly performing clean intermittent catheterization (CIC). Intervention Patients in CONTENT1 and CONTENT2 received aboBoNT‐A injections 600 U (n = 162)/800 U (n = 161), or placebo (n = 162) into the detrusor muscle. Outcome Measurements and Statistical Analysis Primary endpoint: mean change from baseline in number of NDOI episodes/week at Week 6. Secondary endpoints: proportion of patients with no NDOI episodes; incontinence‐related quality of life (I‐QoL); urodynamic parameters; and time‐to‐retreatment. Safety was also assessed. Statistical analyses were conducted for pooled populations by etiology (aboBoNT‐A doses vs. placebo). Results and Limitations Of 485 randomized patients, 341 (70%) and 144 (30%) had SCI and MS etiologies, respectively. A significant reduction was observed in mean NDOI episodes/week at Week 6 with both aboBoNT‐A doses versus placebo in the SCI (all p < 0.001) and MS (all p < 0.01) groups, as well as significant improvements in I‐QoL and urodynamic parameters. Median time‐to‐retreatment was longer in patients with MS (48–62 weeks across doses) than those with SCI (39–44 weeks). Safety data were similar between etiologies. Urinary tract infection was the most frequent adverse event; similar numbers were reported across treatment groups. Conclusions AboBoNT‐A was well tolerated and significantly improved continence and bladder function, and QoL, in patients with SCI or MS with NDOI performing regular CIC. Patient Summary AboBoNT‐A injections improved QoL, symptoms, and bladder function in patients with SCI or MS with bladder muscle overactivity that causes incontinence.

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Section: Discussionsupporting

confidence: 89%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%