Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Stress Urinary Incontinence. (VELSUI)
Urinary Incontinence,Stress
About this trial
This is an interventional treatment trial for Urinary Incontinence,Stress
Eligibility Criteria
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
Sites / Locations
- UZ Leuven
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Non-ablative vaginal Erbium YAG laser treatment
Pelvic floor exercises (PFE)
There are 3 visits where vaginal application of laser will be performed, with a 4-weeks interval. If needed, 3 extra laser applications can be added to the treatment (ie. with a maximum of 6 applications). 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. 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. Each laser treatment session consists of a full vaginal canal irradiation (using a 360° circular adapter), followed by additional irradiation of the prolapsed anterior wall (using a 90° angular adaptor) and concluded with irradiation of the vestibule area.
Standard PFE in Belgium are 9 sessions with a pelvic floor physiotherapist of choice, which can be extended by another 9 sessions, if clinically indicated. There are different strategies, though that will be on discretion of the physiotherapist. We will register the type of physiotherapy (standard (PFMT) versus assisted pelvic floor muscles training (APFMT)), number of completed sessions and duration of therapy. What is exactly done by the patient is registered as a variable.