BACKGROUND AND PURPOSE:

• Genitourinary syndrome of menopause (GSM) includes vaginal moisturizers, lubricants and hormonal therapy
• Fractionated CO₂ laser therapy can lead to tissue remodeling with production of collagen and elastic fibers
• Paraiso et al. (Menopause, 2020) compared 6-month efficacy and safety for treatment of GSM using fractionated CO2 vaginal laser vs estrogen vaginal cream

METHODS:

• Multicenter, randomized controlled trial (RCT)
  • Vaginal Laser therapy to Vaginal Estrogen Therapy (VeLVET) trial
• Participants
  • Menopausal women (no menses for ≥12 months)
  •  Reported significant vaginal dryness (quantified using visual analog scale [VAS] ≥7 cm)
  • Exclusion: Prolapse >stage II | Recent pelvic surgery | Prior mesh surgery | Active genital infection | History of estrogen sensitive malignancy | Autoimmune conditions
• Interventions
  • Fractionated CO₂ laser: 3 intravaginal treatments at least 6 weeks apart
  • Estrogen cream: conjugated estrogen cream 0.5 g intravaginally daily (using applicator or fingertip) for 14 days followed by 0.5 g twice weekly for 24 weeks
• Primary outcome
  • Visual analog scale vaginal dryness score
• Secondary outcomes
  • Evaluation of vaginal atrophy | Quality of life symptoms | Assessment of sexual function | Urinary symptoms
• Statistical analysis
  • Noninferiority study design
  • Predefined noninferiority margin is a difference of 1.0 cm on a 10 cm VAS
  • Primary outcome was presented as the difference in VAS scores between treatments (vaginal estrogen – vaginal laser)

RESULTS:

• Note: Enrollment closed before the completion of the trial due to FDA requiring Investigational Device Exemption (IDE) for laser therapy | IDE would have required a prolonged cessation of enrollment | Authors chose to complete treatment of enrolled participants and close the study
• 69 women enrolled | 62 completed the 6-month protocol
  • 30 women were randomized to laser therapy, 32 to estrogen cream
  • Demographics aside from parity (estrogen more parous) did not differ between groups

Primary Outcome

• Primary outcome: No difference in VAS scores for vaginal dryness
  • No difference between groups (laser -5.48 vs 6.76; P=0.67)
• No differences found for
  • GSM symptoms (vaginal burning, vaginal itching, and dysuria) | Day-to-Day Impact of Vaginal Aging (DIVA) | Female Sexual Function Index (FSFI) | Urogenital distress inventory (UDI) | Vaginal Health Index (VHI) scores.
• Vaginal Maturation Index (VMI) was greater in estrogen group (with linear regression adjustment P=0.02) | Data available for 16 patients randomized to laser vs 18 to estrogen
  • Estrogen group 25 +/- 22.6
  • Laser 3.9 +/- 30.6
• No significant difference found for the following  
  • Improvement between the two groups: Reported as “better or much better”
    • Laser group: 85.8%
    • Estrogen cream group: 70%
  • Satisfaction between the two groups: Reported being either “satisfied or very satisfied”
    • Laser group: 78.5%
    • Estrogen group: 73.3%
• No serious adverse events were reported

CONCLUSION:

• Patients treated with CO₂ laser reported similar improvement in symptoms similar to that of estrogen cream treatment for genitourinary syndrome of menopause reported improvement in symptoms, sexual, and urinary function, similar to participants receiving estrogen cream therapy
• 70 to 80% of participants were satisfied with either treatment
• The authors state

The major limitation of our study was our inability to reach our predetermined statistical power due to early closure of the study because of a request to obtain an IDE to continue. While we cannot state with certainty that CO2 laser treatment is noninferior to vaginal estrogen therapy due to lack of power, we can conclude from our very preliminary results that fractionated CO2 vaginal laser and vaginal estrogen treatment both resulted in improvement in GSM symptoms at 6 months.

Learn More – Primary Sources:

A randomized clinical trial comparing vaginal laser therapy to vaginal estrogen therapy in women with genitourinary syndrome of menopause: The VeLVET Trial

Related ObG Topics:

Genitourinary Syndrome of Menopause: New Name, Old Problem

More Follow-Up Data from the Estrogen vs Lubricant RCT

Treating Postmenopausal Vaginal Atrophy When Estrogen is Not an Option

Vaginal Moisturizers vs Vaginal Estradiol for Postmenopausal Vulvovaginal Symptoms