Long-Term Clinical Effectiveness of and Adherence to Onabotulinumtoxin A Injections for Neurogenic Detrusor Overactivity.

STUDY

DESIGN

Retrospective cohort study in consecutive patients.

OBJECTIVE

To evaluate the long-term effectiveness of and treatment adherence to intradetrusor onabotulinumtoxin A (BoNT-ONA) injections in patients with neurogenic detrusor overactivity (NDO).

METHODS

Consecutive patients with NDO who had undergone intradetrusor BoNT-ONA treatment at a single tertiary neuro-urology referral center were identified from a registry documenting off-label use of BoNT-ONA prior to formal regulatory approval. Demographic, clinical, and urodynamic data obtained before and after each treatment were collected. In patients performing intermittent catheterization, treatment success was defined by the following urodynamic criteria: bladder capacity ≥ 400 mL, bladder compliance ≥20 mL/cmH2O, and maximum detrusor storage pressure <40 cmH2O. In patients with an indwelling catheter, treatment success was defined as the achievement of urinary continence. In addition, data regarding treatment discontinuation and the underlying reasons were collected. Descriptive statistical analyses were performed to evaluate treatment effectiveness, adherence, and discontinuation patterns.

RESULTS

The data of 142 patients (51 females) with a mean age of 35.9 ± 13.1 years and a mean NDO duration of 6.4 ± 8.1 years at the beginning of the BoNT-ONA treatment were analyzed. Over a mean follow-up period of 12.0 ± 6.1 years, evaluated patients received a mean 7.9 ± 5.5 treatments. The BoNT-ONA treatment was continued in 34 (23.9%) patients. In 95 (66.9%) patients, the treatment was discontinued, and 13 (9.2%) patients were lost to follow-up. Five of the 34 patients (14.7%) who continued BoNT-ONA treatment received additional oral medication for NDO. Two (5.9%) and three (8.8%) patients showed reduced bladder compliance and increased detrusor storage pressure, respectively. Ten (34.5%) patients showed increased cystatin C values during the follow-up. The main reason for BoNT-ONA treatment discontinuation was insufficient effectiveness in 56 (58.9%) patients. Most patients who discontinued treatment transitioned to oral medication (45/95, 47.4%) and surgical interventions (25/95, 26.3%).

CONCLUSION

Treatment of NDO with BoNT-ONA injections into the detrusor demonstrated sustained effectiveness in one quarter of the evaluated patients during a follow-up period of more than 12 years. The main reason for BoNT-ONA treatment discontinuation was insufficient effectiveness.