Pilot study of fractional CO2 laser therapy for genitourinary syndrome of menopause in gynecologic cancer survivors

Abstract

Purpose: The objectives of this study were to evaluate the feasibility and efficacy of fractional CO2 laser therapy in gynecologic cancer survivors.

Methods: This was a pilot, multi-institutional randomized sham-controlled trial of women with gynecologic cancers with dyspareunia and/or vaginal dryness. Participants were randomized to fractional CO2 laser treatment or sham laser treatment. The primary aim was to estimate the proportion of patients who had improvement in symptoms based on the Vaginal Assessment Scale (VAS). Secondary aims included changes in sexual function assessed using the Female Sexual Functioning Index (FSFI) and urinary symptoms assessed using the the Urinary Distress Inventory (UDI-6).

Results: Eighteen women participated in the study, ten in the treatment arm and eight in the sham arm. The majority of participants had stage I (n = 11, 61.1 %) or II (n = 3, 16.7 %) endometrial cancer with adenocarcinoma histology (n = 9, 50 %). In total, 15 (83.3 %) of the participants completed all treatments and follow-up visit. There was no difference in the change in the median VAS score from baseline to follow-up. However, there was an improvement in change in the median total FSFI score with treatment compared with sham (Δ 6.5 vs -0.3, p = 0.02). The change in the median UDI-6 score was lower in the treatment arm (Δ -14.6 vs -2.1, p = 0.17), but this was not statistically significant. There were no reported serious adverse events.

Conclusions: Fractional CO2 laser therapy is feasible in gynecologic cancer survivors, with preliminary evidence of safety. In addition, there was preliminary evidence of improvement in sexual function compared with sham treatment. Clinicaltrial.gov Identifier: NCT03372720 (OSU-17261; NCI-2017-02051).

Keywords: Atrophic vaginitis; Cancer survivors; Dyspareunia; Genitourinary syndrome of menopause; Laser therapy; Sexual function; Vaginal atrophy; Vaginal dryness.

Conflict of interest statement

Conflict of interest

Charles Loprinzi reports personal fees from PledPharma, Disarm Therapeutics, Asahi Kasei, Metys Pharmaceuticals, OnQuality, and Mitsubishi Tanabe, which are all outside the submitted work. The other authors have no relevant conflicts of interest or financial disclosures. No financial support was provided by Hologic inc. The laser device was provided by loan to OSU from Hologic/Cynosure. None of the investigators received financial support from Hologic/Cynosure. The company was not involved in study data analysis or manuscript preparation.

Copyright © 2020 Elsevier B.V. All rights reserved.

Figures

Figure 1:

Patient consort diagram

Figure 2:

Distribution of Vaginal Assessment Scale (VAS) scores at baseline (T0/1), prior to T2, T3, and T4. Mean (○, +), median (horizontal lines), and the 1st and 3rd quartiles (Q1: bottom and Q3: top of box) are displayed. The whiskers are the distance equal to 1.5 times the interquartile range (IQR) from Q1 and Q3. The diagram also shows outliers (+) which are values that above or below the whisker ends.

Figure 3:

Distribution of Vulvar Assessment Scale (VuAS) (A), Urinary Distress Inventory-6 (UDI-6) (B), and Female Sexual Function Index (FSFI) (C) scores at baseline (T0/1), T2, T3, and T4. Mean (○, +), median (horizontal lines), and the 1st and 3rd quartiles (Q1: bottom and Q3: top of box) are displayed. The whiskers are the distance equal to 1.5 times the interquartile range (IQR) from Q1 and Q3. The diagram also shows outliers (+) which are values that above or below the whisker ends.

Figure 3:

Distribution of Vulvar Assessment Scale (VuAS) (A), Urinary Distress Inventory-6 (UDI-6) (B), and Female Sexual Function Index (FSFI) (C) scores at baseline (T0/1), T2, T3, and T4. Mean (○, +), median (horizontal lines), and the 1st and 3rd quartiles (Q1: bottom and Q3: top of box) are displayed. The whiskers are the distance equal to 1.5 times the interquartile range (IQR) from Q1 and Q3. The diagram also shows outliers (+) which are values that above or below the whisker ends.