NS-AUA 2024 Annual Meeting Abstracts – Female Urology, Incontinence

Introduction: Stress urinary incontinence (SUI) includes loss of urethral support and intrinsic sphincter deficiency (ISD).We aimed to enhance SUI by integrating intraurethral (IU) with intravaginal (IV) non-ablative Er: YAG laser therapy.The primary objective was to evaluate the safety of IU+IV laser therapy for SUI with ISD components and compare it to IV only and sham through six-and 12-month followups.The secondary objective was to assess the efficacy of the IU+IV and IV-only treatments compared to sham.Methods: Women with proven SUI with a degree of ISD were randomized into IU+IV laser treatment (n=20), IV laser treatment (n=20), and sham control (n=15).The sham subjects were offered the active treatment after a six-month followup.Subjects in both active groups were followed out to 12 months post-treatment.Tolerability and safety were assessed by VAS pain scale, recording of adverse events (AE), and measuring uroflow and post-void residual (PVR).Secondary effectiveness endpoints were assessed by 24-hour pad test, three-day voiding diary, and ICIQ-UI SF and PGI-I questionnaires. Results:We randomized 55 patients into three groups, and 53 patients completed the trial.Thirty-nine adverse events (AEs) were recorded in 23 patients.Seventeen of the 39 recorded AEs were probably related or related to the procedure.Mean (SD) duration of the AEs was 2.93 (3.2) days.The PVR results revealed no clinically meaningful differences between groups (p=0.49), the same as for voiding symptoms at six (p=0.19) or 12 months (p=0.76).At six-month and 12-month followup, >50% reduction of 24-hour pad weight was observed in 64.7% (55.6%) of patients in the IU+IV group, 36.8% (58.8%) in the IV group, and 33.3% in the sham group.The odds of observing a >50% reduction of 24-hour pad weight at six months increased by 246% in the IV+IU arm compared to IV (OR=3.46[0.89-14.9];p=0.08).Conclusions: The addition of the intraurethral treatment did not result in a higher incidence of AEs.In patients with a degree of ISD, combining intraurethral and intravaginal treatments may improve the efficacy of the laser procedure.Clinical studies with a higher number of patients should be performed to confirm the results.Funding: This trial was sponsored by Fotona d.o.o., manufacturer of the laser device used in the trial.