Initial clinical experience with selective bladder denervation for refractory overactive bladder.

AIMS

To report the initial clinical experience with selective bladder denervation (SBD) of the trigone in women with refractory overactive bladder (OAB).

METHODS

Females with refractory OAB underwent SBD of the bladder sub-trigone region. Patients were treated using a 10-s voltage-controlled radiofrequency (RF) algorithm (RF10) at study onset. The protocol was modified during the study after which point remaining patients received 60-s temperature-controlled RF (RF60). Patients were followed for 12 weeks and evaluated for adverse events and changes in OAB symptoms. Exploratory analyses on the influence of RF duration were performed.

RESULTS

Among 63 patients, SBD resulted in statistically significant and clinically important improvements for most outcomes. Comparing RF10 (n = 34) to RF60 (n = 29), treatment benefit was greater with RF60 including mean reduction in urgency urinary incontinence (-2.5 vs -0.9; P < 0.01), urinary incontinence (-2.6 vs -0.8; P < 0.001), and total urgency and frequency score (-13 vs -7; P = 0.02); and improvements in symptom bother (-33 vs -18; P < 0.01) and quality of life (28 vs 16; P = 0.02) on the OAB questionnaire. The proportion of urgency urinary incontinence treatment responders (≥50% reduction in episodes) was 79% with RF60 and 31% with RF10. The frequency of device- or procedure-related adverse events was comparable in RF10 versus RF60 groups (14.7% vs 17.2%).

CONCLUSIONS

This study demonstrated the feasibility of SBD in alleviating symptoms of refractory OAB. A 60-s RF algorithm using deeper ablations of the sub-trigonal tissues was more effective and comparably safe to a 10-s RF algorithm using more superficial ablations.