Clinical trial NCT04643353: Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Stress Urinary Incontinence.
Official title: Use of Non-ablative Vaginal Erbium YAG Laser for the Treatment of Stress Urinary Incontinence.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence,Stress
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Primary outcome is the subjective success rate (cure or improvement) of SUI
timeFrame: 4 months after randomisation
Secondary outcomes:
measure: Assessment of overall urinary symptoms by means of the Urogenital Distress Inventory (UDI-6).
timeFrame: At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment
measure: Assessment of the objective success rate by means of the cough stress test (CST).
timeFrame: At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment
measure: Assessment of the rate of patient satisfaction by means of the Patient Global Impression of Improvement (PGI)
timeFrame: At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment
measure: Assessment of the degree of discomfort of the treatment procedure by the patient
timeFrame: At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment
measure: Assessment of the longevity of the effect of laser therapy
timeFrame: At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment
measure: Assessment of sexual function
timeFrame: At every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatment
measure: Assessment of treatment compliance in the PFE-group
timeFrame: At end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24 months after end of treatmentAt every visit (ie. week 4, 8 and 12), end of initial treatment (ie. 4 months after randomisation), 6, 12 and 24
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jan Deprest, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: