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Almost all studies (93.5%) reported an improvement in validated patient-reported outcomes following treatment.
Vaginal rejuvenation using laser or radiofrequency treatment may be a safe and effective option for patients with genitourinary symptoms associated with vaginal atrophy and urinary incontinence, according to findings from a recent literature review.1
The results were presented at the 2024 Annual Fall Scientific Meeting of the Sexual Medicine Society of North America (SMSNA) in Scottsdale, Arizona.
“The current standard of care is local estrogen, but energy-based treatments have become an emerging treatment option,” the authors wrote. “An FDA statement in 2018 expressed concern over alleged lack of supporting evidence for these therapies, leaving laser and radiofrequency treatment of the vagina somewhat controversial.”
Thus, the authors aimed to conduct an updated review of the literature to gauge the safety and efficacy of these procedures.
In total, the study assessed 77 studies with a total of 5134 patients. Almost all studies (93.5%) reported an improvement in validated patient-reported outcomes following treatment. About half (49.4%) of studies reported incidences of at least minor or transient adverse events (AEs). According to the authors, “These included vaginitis, leukorrhea, vaginal pain, dysuria, urinary tract infection, spotting/bleeding, and burning.” The authors noted that the majority of AEs were minor.
For efficacy assessments, 10 studies included a placebo control arm, with 8 of those reporting improvements in the sham group. Only 4 studies found a significant difference between the treatment and placebo groups in improvements in reported outcomes.
Overall, for the study, the authors assessed 1374 studies from Embase (n = 792), PubMed (n = 376), and CENTRAL (n = 206) between November 2018 and June 2024.
For inclusion in the review, studies needed to include adult patients who were undergoing laser or radiofrequency therapy of the vagina for a specific genitourinary complaint, as well as a report of adverse effects and patient-reported outcomes following treatment. Studies were excluded if they explored combination therapies or included purely cosmetic indications, animal or cadaver models, or patients with an active infectious or neoplastic genitourinary pathology.
Among all studies identified, 1059 were screened and 295 were assessed for eligibility. Ultimately, 77 studies were included in the review with a total of 5143 patients. Among these studies, 27 were randomized controlled trials, 40 were prospective interventional studies, and 10 were retrospective studies.
The majority (79%; n = 61) of studies evaluated only the use of laser treatment. Thirteen studies assessed radiofrequency alone, and 3 evaluated both. The indication for treatment was stress urinary incontinence in 18 studies and genitourinary syndrome of menopause or related symptoms in 59 studies.
Based on these data, the authors suggest, “According to recent literature, laser and radiofrequency treatment of the vagina consistently results in an improvement in reported outcomes from patients with genitourinary symptoms associated with vaginal atrophy and urinary incontinence.”
However, they also note that further research is necessary.
“More randomized controlled trials with sham groups are needed to elucidate the extent that placebo effect may play in treatment outcomes,” they wrote. “Further investigation into objective physiological changes and their correlation to clinical outcomes is needed.”
Reference
1. Ricottone J, Richards R, Reese A, Burke M, Brennan M. Vaginal rejuvenation by laser or radiofrequency: A systematic review of the literature. Presented at: 2024 Sexual Medicine Society of North America Fall Scientific Meeting. October 17-20, 2024. Scottsdale, Arizona. Poster 196