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

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

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.

Inclusion Criteria:

• 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). Scores are from 0 to 12. The higher the score, the more severe the urinary incontinence (mild=1-2, moderate= 3-6, severe=8-9, very severe=12).
• Voluntary informed consent

Exclusion Criteria:

• Any previous PFE-treatment in the last year for the same problem
• Previous surgery for incontinence or prolapse
• Severe (Sandvik SIS ≥8) SUI or insensible loss, high suspicion of intrinsic sphincter deficiency (ISD)
• Prolapse grade III or more
• Pregnancy
• Vaginal bleeding, injuries or infection in the treated area