Treatment for Vaginal Atrophy Using Microablative Fractional CO2 Laser

A Randomized Double-Blinded Sham-Controlled Trial

Purim Ruanphoo, MD; Suvit Bunyavejchevin, MD, MHS

Disclosures

Menopause. 2020;27(8):858-863. 

In This Article

Results

A total of 88 participants were randomized. In the laser group (n = 44), three participants withdrew from the study. One participant withdrew from the study because she could not tolerate the pain when the vaginal probe was inserted into the vagina. The other two women withdrew from the study claiming that it was inconvenient for them to come according to the schedule of the study. In the sham group (n = 44), six participants were lost to follow-up because it was inconvenient for them to come in to receive the treatment. Because we planned to use the ITT analysis for this study, all 44 participants from each group were included for analysis (Figure 1). Linear regression technique was used to impute those missing outcome data for the analysis. We had nine missing outcome data (three in the laser group and six in the sham group). The mean ± SD age of the enrolled women was 60.78 ± 7.77 years. The mean ± SD age at menopause was 49.21 ± 3.49 years. Thirty-four women (38.64%) were sexually active (10 [22.73%] in the laser group and 24 [54.55%] in the sham group; Table 1).

Figure 1.

CONSORT flowchart of participants.

Outcome measurements at baseline are shown in Table 2. In the laser group, the mean ± SD VHI and VAS scores were 14.18 ± 3.39 and 2.27 ± 0.42, respectively. In the sham group, the mean ± SD VHI and VAS scores were 14.66 ± 2.91 and 2.02 ± 0.40, respectively. At baseline, the VHI score (P = 0.48), VAS score (P = 0.06), and ICIQ-VS, the item for vaginal dryness (P = 0.09) were comparable between both groups (Table 2). Data were compared between baseline and 12-week follow-up (Table 2). In the laser group, there was significant improvement for all outcomes at week 12 when compared to baseline. The VHI score significantly increased from 14.18 ± 3.39 at baseline to 17.45 ± 2.61 at 12-week follow-up, P < 0.001. The VAS score decreased from 2.27 ± 0.42 to 1.83 ± 0.51, P < 0.001. As for ICIQ-VS, the item for vaginal dryness significantly decreased from 5.00 (2.00–6.00) to 3.24 (0–4.00), P = 0.02. In the sham group, there was no statistical difference of the VHI score at 12-week follow-up period (P = 0.06). The VAS score increased from 2.02 ± 0.40 at baseline to 2.06 ± 0.49 at 12-week follow-up (P = 0.59). The ICIQ-VS, the item for vaginal dryness decreased at week 12 (P = 0.07) (Table 2).

Because the outcomes at baseline were not significantly different between groups, we assumed that the outcomes at 12-week follow-up could represent the change after treatment. When we compared the outcomes at 12-week follow-up with the ITT analysis, there was statistically significant differences between the two groups for VHI score (P < 0.001) and VAS score (P = 0.03) with the mean difference of 1.37 (95% CI: 0.12–2.63) and −0.23 (95% CI: −0.45 to −0.27), respectively. There was, however, no significant differences for ICIQ-VS, the item for vaginal dryness (P = 0.56) (Table 2). The results from per-protocol analysis were similar to the ITT analysis. A one-way analysis of covariance was conducted to determine whether there were any significant differences between the laser and sham groups for VHI score at 12-week follow-up after controlling for active sexual status. After the active sexual status was controlled, we saw a significant improvement in the VHI score in the laser group compared to the sham group (F (1,86) = 6.47, P < 0.05).

Seventy-seven women answered the satisfaction evaluation questionnaire (39 women from the laser group and 38 women from the sham group). The comparison of the participants' satisfaction from both groups is shown in Table 3. There was a significant difference between the two groups for "very satisfied or satisfied" and "neither satisfied nor dissatisfied or lower" (P = 0.002). Participants experiencing minor adverse events (ie, vaginal bleeding, vaginal discharge, vaginitis, and pain after procedure) are shown in Table 4. The adverse events were not statistically significant between the groups. One participant from the laser group was diagnosed with bacterial vaginosis 1 week after the procedure and was treated with oral metronidazole for 7 days.

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