Clinical trial NCT04021966: Use of Fractional CO2 Laser for the Treatment of Vulvovaginal Atrophy: a Double-blinded Randomized Placebo-controlled Clinical Trial.
Official title: Use of Fractional CO2 Laser for the Treatment of Vulvovaginal Atrophy: a Double-blinded Randomized Placebo-controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvovaginal Atrophy
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2019-07-16
Enrollment: 60
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Purpose of the trial is to study the efficacy of fractional laser in alleviating genitourinary symptoms in menopausal women.

Primary outcome of the study is the efficacy of the laser procedure, intended as the amelioration of the severity of most bothersome symptom (MBS).

Therefore we conducted a single center, double-blinded randomized placebo-controlled cross-over trial.


Eligibility criteria: Inclusion Criteria:

Healthy women with menopausal status (\>1 year amenorrhea) AND with moderate to severe symptoms of VVA as measured by the MBS score ≥2.

Exclusion Criteria:

* Acute or recurrent urogenital infections
* Prolapse ≥ grade 3 according to the Pelvic Organ Prolapse Quantification System
* Hormonal replacement therapy within the last 6 months before study entry
* Use of local estrogens, moisturizers, lubricants or homeopathic preparations within the last 3 months
* Pelvic floor physiotherapy for pelvic floor disorders within the last 3 months
* Any condition that could interfere with study compliance

Primary outcomes:
measure: Primary outcome measure is the change in severity of most bothersome symptom (MBS)
timeFrame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Secondary outcomes:
measure: Assessment of the effect of treatment on the female urogenital health, by means of the globally validated "Vaginal Health Index Score" (VHIS).
timeFrame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
measure: Assessment of the effect of treatment on the female urogenital health, by means of vaginal pH measurements.
timeFrame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
measure: Assessment of the effect of treatment on VVA symptoms (vaginal dryness, vaginal burning, vaginal itching, dyspareunia and dysuria) using the Visual Analog Scale (0-10cm, continuous scale).
timeFrame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
measure: Assessment of the rate of patient satisfaction by means of the Patient Global Impression of Improvement (PGI), using a 5-point Likert scale (1=much worse, 2=worse, 3=same, 4=better, 5=much better).
timeFrame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
measure: Assessment of the degree of discomfort of the treatment procedure by the patient, by mean of a VAS-score(0-10cm, continuous scale).
timeFrame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
measure: Assessment of the degree of difficulty encountered by the physician in performing the treatment, by means of a 5-point Likert scale (1=very difficult, 2=difficult, 3=neutral, 4=easy, 5=very easy).
timeFrame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
measure: Assessment of the long term satisfaction with, and the longevity of the effect of laser therapy, measured by the need for, and the timing for repeating the same, or initiating an alternative therapy.
timeFrame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
measure: Assessment of the vaginal wall thickness using in vivo microscopy (vaginal focal depth measurement).
timeFrame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
measure: Effect of treatment, in sexually active patients, on female sexual function, by means of the validated "Female Sexual Function Index" (FSFI) specific questionnaire
timeFrame: Will be measured at baseline and during every next visit (vaginal applications and follow-up visits); ie. 0 weeks, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks, 3 months, 6 months and 12 months post treatment
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References: