The treatment of refractory overactive bladder is currently limited to neuromodulation (sacral nerve stimulation or percutaneous tibial nerve stimulation) or botulinum toxin injections. Although all these options are valuable, they have their own limitations and may not be suitable for some, by failing to be efficacious, unacceptable adverse effects, or other factors such as lack of availability or funding. This study explores a much-needed further option for such patients, by re-exploring the modified Ingelman-Sundberg surgical procedure using new technology. The principle is surgical de-afferentation, or selective bladder denervation, which in this study has been administered using radiofrequency ablation using a cystoscopic device which allows direct visualisation of the bladder and trigone throughout the procedure. Two protocols (RF60 and RF10) were compared in a total of 63 women. With the RF60 protocol, which was temperature-controlled deeper ablation for 60 seconds, a 79% response was observed (≥50% reduction in urgency urinary incontinence episodes). This study follows on from ovine data (references below) and use of the voltage-controlled RF10 algorithm interim efficacy data. Adverse effects occurred in 15.9%, most commonly urinary tract infection and post-procedural pain. No occurrences of bleeding, fistulation, perforation or urinary retention were reported. Although exciting as a potentially new treatment modality, it must be remembered that this is the first study of this in humans and on a small cohort of patients, and consequently larger numbers, controlled trials, and longer term data must become available for this to be safe for clinical practice.
