Academic hospital starts a clinical trial of non-ablative Vaginal Erbium YAG Laser for the Treatment of Stress Urinary Incontinence

Photo by Martha Dominguez de Gouveia

Universitaire Ziekenhuizen Leuven is starting a new clinical trial of Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Stress Urinary Incontinence.

This is a study, sponsored by the UZ Leuven, Leuven, Belgium; comparing laser treatment to pelvic floor exercises (PFE).

Women with symptomatic stress urinary incontinence who seek for a conservative treatment, with no history of previous incontinence-surgery will be randomised to either the laser-arm or the PFE-arm.

The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators.

The primary objective is to evaluate the effects of VEL treatment for the subjective cure or improvement of SUI.

The clinical trial started in November 7, 2020 and will continue throughout December 2023.

Primary outcome is the subjective success rate (cure or improvement) of SUI.

The population that can be enrolled into this study includes the patients with the presence of mild (score 1-2) to moderate (3-6) SUI with wish for treatment. The patient can have concomitant urge urinary incontinence (UUI), but that should not be the leading factor. Incontinence severity will be categorized by the four-level Sandvik severity index score (SIS).

Universitair Ziekenhuis Leuven, often shortened to UZ Leuven, is an academic hospital in Leuven, Belgium, associated with the university KU Leuven.

The contacts and locations are the UZ Leuven, Leuven, Belgium. For more details: https://ichgcp.net/clinical-trials-registry/NCT04643353