Use of Fractional CO2 Laser for the Treatment of Vulvovaginal Atrophy: a Double-blinded Randomized Placebo-controlled Clinical Trial.

NCT04021966 | Completed DMC

• 1 other identifier: S61680
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Vulvovaginal Atrophy

Outcome Measures

Primary Outcomes (1)

• Primary outcome measure is the change in severity of most bothersome symptom (MBS)

  The MBS is derived from a selected list of symptoms (consisting of the four most common symptoms of vaginal dryness, vaginal itching/irritation, vaginal soreness and dyspareunia). At baseline, participants are instructed to rate each of these symptoms as not present, mild, moderate or severe and then are asked to select a single symptom among those classified as moderate or severe as the MBS. The MBS is then followed through to the end of treatment, and the change in its severity is used to evaluate symptomatic improvement.

  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 (9)

• Assessment of the effect of treatment on the female urogenital health, by means of the globally validated "Vaginal Health Index Score" (VHIS).

  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

• Assessment of the effect of treatment on the female urogenital health, by means of vaginal pH measurements.

  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

• 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).

  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

• 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).

  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

• Assessment of the degree of discomfort of the treatment procedure by the patient, by mean of a VAS-score(0-10cm, continuous scale).

  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

Study Arms (2)

Laser

EXPERIMENTAL

In this arm, participants will have 3 real laser treatments first, followed by 3 consecutive sham treatments.

Procedure: Vaginal laser application

Sham

SHAM COMPARATOR

In this arm, participants will have 3 sham treatments first, followed by 3 consecutive real laser treatments.

Procedure: Vaginal laser application

Interventions

Vaginal laser application PROCEDURE

One laser treatment cycle consists of 3 vaginal laser applications with a 4-weeks interval. Each application lasts around 5 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. A vaginal probe will be gently inserted and manually rotated to provide a 360° treatment of the vaginal mucosa.

Laser; Sham

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• prof. dr. Jan Deprest: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (1)

• Page AS, Verbakel JY, Verhaeghe J, Latul YP, Housmans S, Deprest J. Laser versus sham for genitourinary syndrome of menopause: A randomised controlled trial. BJOG. 2023 Feb;130(3):312-319. doi: 10.1111/1471-0528.17335. Epub 2022 Nov 15.

  PMID: 36349391 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 16, 2019
• Study Start: August 1, 2019
• Primary Completion: September 27, 2021
• Study Completion: December 31, 2021
• Last Updated: January 10, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)