NCT04643353

Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Stress Urinary Incontinence.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a single center, investigator initiated 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. There are 3 visits (with a maximum of 6 visits) where vaginal application of laser will be performed, with a 4-weeks interval. Each application lasts around 15 minutes. 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 secondary objectives are to measure objective outcomes, to register any adverse events, and to determine for how long the effects of laser are sustained, with a maximum of two years.

Conditions

• Urinary Incontinence,Stress

Interventions

Type	Name	Description
DEVICE	Non-ablative vaginal Erbium YAG laser treatment	Laser therapy is performed using a 2940 nm VEL (SP Spectro, Fotona, Slovenia) with SMOOTH mode setting, which enables non-ablative, thermal-only operation. The parameters are selected based on extensive preclinical and clinical studies.
OTHER	PFE	PFE will be prescribed as it is already implemented in clinical practice (i.e. up to 2x 9 sessions with a pelvic floor physiotherapist of choice). Type of physiotherapy, number of completed sessions and duration of therapy will be recorded.

Timeline

• Start date: 2020-11-27
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2020-11-25
• Last updated: 2024-09-26

Locations

1 site across 1 country: Belgium