Treatment of bladder neck dissynergia with transurethral injection of OnabotulinumtoxinA: objective and patient-reported results

Background: Current therapies for lower urinary tract symptoms (LUTS) due to bladder-neck dyssynergia (BND) have many limitations. Objective: To determine efficacy and safety of OnabotulinumtoxinA (BoNT-A) injection therapy in medically-refractory patients with LUTS due to BND. Design, Setting, and Participants: Prospective single-armed cohort study. Therty-five consecutive ambulatory males, younger than 50 yr and diagnosed with BND refractory to medical therapy, with IPSS>15, Qmax<15 ml/s and total prostate volume <30 cm3, were screened from January 2010 and December 2011. Patients were assessed at baseline, two, six, nine and 12 mo postprocedure and until duration of clinical response. Intervention: Transurethral bladder-neck injection of 200 U of BoNT-A (50 U/ml x 4 sites). Outcome Measurements: Kaplan-Meier survival analysis addressed the response rate according to an improvement in IPSS from baseline ≥25%. Secondary outcomes were changes from baseline in total, storage and voiding IPSS, QoL score, Qmax and post-voiding residual volume (PVR), patient-reported outcome measures, complications and adverse effects. Results: Of 30 enrolled patients (mean age 33.8 yr), 29 (96.7%) completed the study. Response rates were as high as 86.7% ±6.2, 76.7% ±7.7, 31.4% ±8.6, 10.5% ±5.7 and 0.0% at two, six, nine, 12 and 16 mo, respectively. Mean time to failure was 8.9 ±0.7 mo. Statistically significant improvements from baseline of total, storage and voiding IPSS, QoL score, Qmax and PVR were observed until nine mo postprocedure. The proportion of patients with overall satisfaction was favourable although decreasing from 80% at two mo, to 46% at 12 mo. No significant complications and adverse effects were noted. The lack of a placebo arm limits the level of evidence. Conclusions: BoNT-A injection therapy is effective and safe in improving LUTS and uroflow parameters in medically-refractory men with BND, although repeated procedures are required for long-term sustained benefit.