Genitourinary syndrome of menopause (GSM) affects women after breast cancer under antihormonal therapy in up to 61%. Hormone-free therapies like intravaginal laser therapy and hyaluronic acid suppositories have shown symptom relief in women with breast cancer, but have not been tested against each other. The aim of this study was to compare the efficacy of intravaginal GSM treatment in women with breast cancer in a randomized fashion.

In this randomized controlled trial we randomly assigned 45 women (age 54, IQR: 49 – 58) with GSM and a history of breast cancer to receive intravaginal laser therapy (2 courses within 1 months) versus hyaluronic acid suppositories (3 times per week continuously for three months). The primary end-point was the improvement of the vaginal health index (VHI) score after 3 months. Secondary endpoints were subjective bother for all GSM symptoms, i.e. vaginal atrophy, dyspareunia, urinary incontinence on a visual analogue scale. Quality of life and sexual health were assessed with the EORTC QR45 and SHQ-C22 questionnaire.

45 women underwent randomization, 22 were randomized to intravaginal laser therapy, 23 to vaginal suppositories with 21 women being available for follow-up. 
At baseline, the VHI was 9 in the laser groups vs. 13 in the suppository group indicating vaginal atrophy in all study participants. The score improved significantly in both groups (p=0.001) but did not reveal any differences between intravaginal laser therapy versus hyaluronic acid suppository therapy (median: 10, IQR: 8 – 14 to 13, 11-17; p= 0.232). 

At baseline, vaginal atrophy and dyspareunia were the most bothersome GSM symptoms affecting more than 80% of women. At three months follow-up, most GSM symptoms improved significantly without any significant difference between treatment type. 
The bother of vaginal atrophy on a numeric rating scale improved from 7 to 3 points in the laser group (p<0.001) and from 4 to 2 in the suppository group (p=0.002) in line with a significantly improved VHI index in both groups.

The overall score in terms of pelvic floor symptoms improved significantly in both groups (p=0.008 and 0.029), however, similar to the remaining results, not between treatment groups (0.650). The incontinence domain showed a significant improvement in the laser group (0.017) but not in the suppository group. Conversely, the sexual health domain improved significantly in the suppository group (0.007) but did not reach significance in the laser group (0.054).

Significant improvement was also seen in both groups for quality of life and sexual health, without significant differences between laser and hyaluronic acid therapy.

Quality of life and sexual health can significantly improve in women with breast cancer suffering from genitourinary syndrome of menopause after treatment with intravaginal laser therapy and hyaluronic acid suppositories.

Both intravaginal laser therapy and hyaluronic acid suppositories are effective treatment options for women after breast cancer suffering from GSM. No difference was found between treatment regimens. (ClinicalTrials.gov number, NCT03816735).