Objective: Clinical trials have demonstrated the safety and efficacy of non-surgical, transurethral radiofrequency (RF) collagen denaturation for treating female stress urinary incontinence (SUI) due to hypermobility. Women in those trials were anesthetized using intravenous conscious sedation. This multicenter trial aimed to demonstrate the feasibility, safety, and efficacy of an oral sedation and local anesthetic regimen in performing RF collagen denaturation.
Design and methods: This single-arm study enrolled 33 women, each diagnosed with SUI due to hypermobility, at three United States sites (private physician offices). All women were pretreated with an oral sedative (diazepam) and antibiotic (quinolone) and underwent a bilateral peri-urethral block using 10 cc total of 2% lidocaine. Non-surgical, transurethral RF collagen denaturation was then performed.
Main outcome measures: The feasibility of the in-office anesthetic regimen was determined based on the number of RF collagen denaturation treatments completed without conversion to intravenous conscious sedation. To assess the patients' subjective level of pain, a visual analog scale (VAS) (0 = no pain; 10 = terrible pain) was completed by each patient immediately before discharge.
Results: The in-office anesthetic regimen allowed for treatment completion in all patients (100% feasibility). On the VAS, 42% of the women rated their pain as 0; the mean pain score was 1.4 (SD 1.8). One woman (3% prevalence) experienced two clinically minor adverse events not conclusively related to the anesthetic regimen; both resolved spontaneously without treatment.
Conclusions: The results of this trial were similar to those of larger, sham-controlled studies using intravenous conscious sedation and showed non-surgical RF collagen denaturation to be feasible, safe, and effective when performed using in-office anesthesia.