Pilot single-masked, randomized, 3-arm parallel study assessing the tolerability, safety and efficacy of intraurethral/intravaginal 2940nm Er:YAG laser treatment for stress urinary 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 is to evaluate the safety of IU+IV for SUI with ISD components and compare it to IV only and sham through 6- and 12-month follow-ups. Secondary, to assess the efficacy of the IU+IV and IV-only treatments compared to sham.

Method

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 6-month follow-up. Subjects in both active groups were followed out to 12-month post-treatment.

Results

We randomized 55 patients into three groups and 53 patients completed the trial. 39 AEs were recorded in 23 patients. 17/39 recorded AEs were probably related or related to the procedure. Among these, 7 cases were associated with increased SUI, 4 with urethral pain, 2 with pelvic pain, 2 with vulval/vaginal pain, 1 with dysuria and 1 with de novo SUI. Mean (SD) duration of the AEs was 2.93 (3.2) days. VAS pain scale at treatment 1 seems higher in the group IV+IU compared to sham and IV. At 6-months (and 12 months) follow-up >50% reduction of 24h-pad weight was observed in 64.7% (55.6%) of patients in IU+IV group 36.8% (58.8%) in IV group, and 33.3% in sham group. The odds of observing a > 50% reduction of 24h-pad weight at 6 months increase of 246% in the IV+IU arm compared to IV (OR = 3.46 [0.89 - 14.9]; p = 0.08). At 6-month follow-up > 2.5 points, reduction of ICIQ-SF was observed in 57.9% of IV+IU group, 63,2% of IV group, and 33,3% of sham group. At 12-month follow-up > 2.5 points reduction of ICIQ-SF was observed in 55,6% of IV+IU group and 47,8% of IV group.

Conclusion

The addition of the intraurethral treatment did not result in a higher incidence of adverse effects. In patients with a degree of ISD, combining IU+IV treatments may improve the efficacy of the laser procedure. Clinical studies with a higher number of patients should be performed to confirm the results.