Pilot study evaluating the safety of intradetrusor injections of botulinum toxin type A: investigation of generalized spread using single-fiber EMG.

AIMS: Intradetrusor botulinum toxin type-A injections are a novel therapy for treatment of neurogenic overactive bladder resistant to parasympatholytic treatment. In rare cases, however, it may be associated with generalized muscle weakness. Single-fiber electromyographic (SFEMG) analysis of neuromuscular jitter (NJ) was used to study OnabotulinumtoxinA (BOTOX®) migration to striated muscle.

METHODS

This study comprised a prospective, single-center investigation of 21 spinal cord injured patients receiving intradetrusor OnabotulinumtoxinA. Clinical tolerance was assessed through muscle testing and para-clinical tolerance by systematic analysis of NJ in muscles distant from the bladder.

RESULTS

Twenty-one patients (13 males, 8 females) received one intradetrusor injection of 300  U OnabotulinumtoxinA. Mean age was 42.1  ±  14.4 and mean number of injections prior to study inclusion was 2.6  ± 1.7. Clinical and para-clinical assessments were performed on average 26 days  ±  8 days post-OnabotulinumtoxinA injection. Seven patients had abnormal NJ results on SFEMG, but no patient had evidence of blocking. Four patients complained of tiredness (one with NJ abnormalities).

CONCLUSIONS

Patients showed good tolerance to intradetrusor OnabotulinumtoxinA injections. Tiredness was not associated with generalized muscle weakness since testing remained unchanged and NMJ was normal in three of four patients. NJ analysis was abnormal in 7 of 21 patients, but this was not considered serious and there was no evidence of muscle fiber block. These results support the safety of bladder injections of OnabotulinumtoxinA and suggest that, although migration of OnabotulinumtoxinA to other muscle groups may impair NJ function in a minority of patients, this does not correlate with symptoms of tiredness or muscle weakness.