A Double-Blind Randomized Sham-Controlled Trial to Evaluate the Efficacy of Fractional Carbon Dioxide Laser Therapy on Genitourinary Syndrome of Menopause

Cruff, Jason; Khandwala, Salil

doi:10.1016/j.jsxm.2021.01.188

Cited by 34 publications

(51 citation statements)

References 46 publications

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“…A small randomized double-blind, shamcontrolled study in 30 postmenopausal women did not demonstrate a difference in vaginal symptoms, sexual function, or urinary symptoms between the treatment arm (n = 14) and the sham-controlled arm (n = 16). However, the study was likely underpowered due to its small sample size [49]. Another recently published sham-controlled randomized trial of 85 postmenopausal women, 50% of whom had a history of breast cancer, also showed no improvement in vaginal symptoms with laser treatment compared to sham treatment with 12 months follow-up [50].…”

Section: Discussionmentioning

confidence: 98%

“…Similar to vaginal estrogen treatment, vaginal laser treatment has been shown to increase the thickness of vaginal epithelium and improve the quality of the vaginal mucosa [14]. However, there is still limited prospective data with long-term follow-up and there are some studies which failed to show an improvement with laser treatment [49,50].…”

Section: Discussionmentioning

confidence: 99%

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Long-Term Follow-Up of Fractional CO2 Laser Therapy for Genitourinary Syndrome of Menopause in Breast Cancer Survivors

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Hundley

Evans

et al. 2022

JCM

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(1) Background: The objective of this study was to determine the long-term efficacy of fractional CO2 laser therapy in breast cancer survivors. (2) Methods: This was a single-arm study of breast cancer survivors. Participants received three treatments of fractional CO2 laser therapy and returned for a 4 week follow-up. Participants were contacted for follow-up at annual intervals. The Vaginal Assessment Scale (VAS), the Female Sexual Function Index (FSFI), the Female Sexual Distress Scare Revised (FSDS-R), the Urinary Distress Inventory (UDI), and adverse events were collected and reported for the two-year follow-up. The changes in scores were compared between the four-week and two-year and the one-year and two-year follow-ups using paired t-tests. (3) Results: In total, 67 BC survivors were enrolled, 59 completed treatments and the four week follow-up, 39 participated in the one-year follow-up, and 33 participated in the two-year follow-up. After initial improvement in the VAS from baseline to the four week follow-up, there was no statistically significant difference in the VAS score (mean Δ 0.23; 95% CI [−0.05, 0.51], p = 0.150) between the four week follow-up and the two-year follow-up. At the two-year follow-up, the FSFI and FSDS-R scores remained improved from baseline and there was no statistically significant change in the FSFI score (mean Δ −0.83; 95% CI [−3.07, 2.38] p = 0.794) or the FSDS-R score (mean Δ −2.85; 95% CI [−1.88, 7.59] p = 0.227) from the one to two-year follow-up. The UDI scores approached baseline at the two-year follow-up; however, the change between the one- and two-year follow-ups was not statistically significant (mean Δ 4.76; 95% CI [−1.89, 11.41], p = 0.15). (4) Conclusions: Breast cancer survivors treated with fractional CO2 laser therapy have sustained improvement in sexual function two years after treatment completion, suggesting potential long-term benefit.

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Section: Discussionmentioning

confidence: 98%

Section: Discussionmentioning

confidence: 99%

Long-Term Follow-Up of Fractional CO2 Laser Therapy for Genitourinary Syndrome of Menopause in Breast Cancer Survivors

Quick

Hundley

Evans

et al. 2022

JCM

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“…At the end it is important to noticed that the latest works confirm the safety and efficiency of CO2 laser treatment in genitourinary syndrome are randomized trials with good quality data [27][28][29].…”

Section: Discussionmentioning

confidence: 99%

The CO2 ablative laser treatment in perimenopausal patients with vulvovaginal atrophy

2021

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“…Only one small RCT has been conducted with fractional CO 2 therapy in breast and gynecologic cancer survivors, and it appeared to change vaginal symptoms, including improvement of sexual function 51 . Larger RCTs in cancer patients are needed to confirm these beneficial results, particularly since this is a minimally invasive procedure ideally performed by an experienced gynecologist, 84 and recent double-blind RCTs have not found benefit in healthy postmenopausal women 85,86 . It should be noted that currently, the utilization of laser has not been fully approved by FDA to treat any gynecologic problems.…”

Section: Discussionmentioning

confidence: 99%

“…51 Larger RCTs in cancer patients are needed to confirm these beneficial results, particularly since this is a minimally invasive procedure ideally performed by an experienced gynecologist, 84 and recent double-blind RCTs have not found benefit in healthy postmenopausal women. 85,86 It should be noted that currently, the utilization of laser has not been fully approved by FDA to treat any gynecologic problems.…”

Section: Discussionmentioning

confidence: 99%

Efficacy of interventions to manage sexual dysfunction in women with cancer: a systematic review

et al. 2022

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Importance: Cancer and its treatment negatively affect female sexual health and function. The prevalence of female sexual dysfunction after cancer is between 33% and 43%. Numerous studies have addressed treatment options for sexual dysfunction in women with cancer, but it still remains a challenge to select the most efficacious option for patients.Objective: To compile and appraise recent evidence of any interventions for managing sexual dysfunction in female cancer survivors.Evidence Review: A literature search of the electronic databases MEDLINE, EMBASE, PsycINFO, and Cochrane Central Register of Controlled Trials (January 2011 to February 2021) was conducted using general search terms of ''women'', ''cancer'', ''intervention'', ''sexual dysfunction''. We included randomized controlled trials (RCTs) and uncontrolled before-after studies that evaluated the efficacy of intervention for female sexual dysfunction in women with history of cancer. Methodological quality of studies was assessed using Risk of Bias (RoB) 2.0 for RCTs and National Institutes of Health (NIH) assessment tools for uncontrolled before-after studies.Findings: Thirty-six studies were included for qualitative synthesis (14 RCTs (n ¼ 1284), 17 uncontrolled trials (n ¼ 589), and 5 cohort studies (n ¼ 497). Only four studies were at low risk of bias. Topical interventions (vaginal gels or creams) were able to alleviate vaginal dryness and dyspareunia, with intravaginal dehydroepiandrosterone (DHEA) (6.5 mg) gel showing evidence of improved sexual function. Evidence for estriol-lactobacilli vaginal tablets was unreliable due to a small-scale study. Psychoeducational therapy (internet-based cognitive behavioral therapy [CBT]) studies typically were at high risk of bias, but all displayed significant improvements of sexual function. Both laser therapy (fractional CO 2 and erbium) and multimodal approach studies were at concerning risk of bias, although suggesting beneficial effects on sexual function.Conclusions and Relevance: The most reliable evidence for improvement was from a study of DHEA vaginal gel, but in general, gels or creams were useful in reducing dyspareunia. Pharmacological, psychoeducational, laser therapy, and multimodal approaches demonstrated potential in managing cancer-related sexual issues, but most were small in size (10-70 participants), with moderate to high risk of bias. Therefore, large-scale, double-blind, RCTs with long-period follow-up, and at low risk of bias are needed to show efficacy for these interventions.

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A Double-Blind Randomized Sham-Controlled Trial to Evaluate the Efficacy of Fractional Carbon Dioxide Laser Therapy on Genitourinary Syndrome of Menopause

Cited by 34 publications

References 46 publications

Long-Term Follow-Up of Fractional CO2 Laser Therapy for Genitourinary Syndrome of Menopause in Breast Cancer Survivors

Long-Term Follow-Up of Fractional CO2 Laser Therapy for Genitourinary Syndrome of Menopause in Breast Cancer Survivors

The CO2 ablative laser treatment in perimenopausal patients with vulvovaginal atrophy

Efficacy of interventions to manage sexual dysfunction in women with cancer: a systematic review

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