Introduction: Transurethral radiofrequency (RF) collagen denaturation (Renessa) is approved for nonsurgical treatment of stress urinary incontinence (SUI) due to urethral hypermobility. RF energy applied through a transurethral probe heats submucosal tissue to reduce tissue compliance without necrosis, thus distinguishing this procedure from surgical transvaginal or laparoscopic RF tissue ablation (SURx). This study aimed to determine long-term durability of RF collagen denaturation.
Materials and Methods: A controlled, in-office trial blindly randomized women with SUI to receive RF collagen denaturation (n=110) or identical sham treatment without RF delivery (n=63). Ninety-one active-treatment patients were evaluated at 1-year and 21 at ≥3 years posttreatment. Patients completed the Incontinence Quality of Life (I-QOL) questionnaire, 3-day voiding diaries, and a treatment satisfaction questionnaire.
Results: Outcome measures were: ≥10-point I-QOL improvement from baseline; any improvement at 1 year, with ongoing improvement at ≥3 years; and fewer incontinence episodes at 1 year, with ongoing decrease at ≥3 years. I-QOL scores improved at ≥3 years in 16/21 women (mean improvement, 17.6). Twelve women (55%) had ≥10-point I-QOL improvement at ≥3 years. Most patients were satisfied with results after 3 years. Five women with recurrent SUI symptoms had undergone additional incontinence procedures prior to 3-year follow-up and were evaluated for the impact of RF collagen denaturation on subsequent treatments. No long-term safety issues were identified.
Conclusions: Transurethral RF collagen denaturation is safe and effective for SUI patients, demonstrating durable improvements in QOL, incontinence frequency, and patient satisfaction ≥3 years posttreatment. This treatment does not negatively impact subsequent procedures.