Four vaginal energy devices tied on symptoms — with no sham arm to beat

Energy-based devices — vaginal lasers and radiofrequency systems — are widely marketed for genitourinary syndrome of menopause, the cluster of dryness, painful intercourse, and urinary symptoms that follows the loss of oestrogen. A four-arm randomised trial published in Maturitas on September 25 compared four of them against each other, and found no difference [s1].

The result is worth reading carefully, because what the trial compared determines what the result can mean.

What the trial did

Forty-eight postmenopausal women with genitourinary syndrome of menopause were randomised into four groups in a single-blind trial registered with the Brazilian Registry of Clinical Trials (RBR-5vw3vpg) [s1]. Group 1 received non-ablative Er:YAG laser, Group 2 microablative CO2 laser, Group 3 non-ablative radiofrequency, and Group 4 fractional microablative radiofrequency [s1].

The primary outcome combined symptom assessment with vaginal histological analysis at baseline and one month after treatment ended [s1]. Secondary outcomes were sexual function, urinary symptoms, treatment satisfaction, and major adverse events [s1].

Including histology is unusual and useful. Symptom scales in this condition move a great deal with attention and expectation; tissue does not.

The findings

All four modalities produced significant improvement in dryness (p < 0.001) and dyspareunia (p < 0.001) on visual analogue scales, and in vaginal symptoms measured by the International Consultation on Incontinence Questionnaire–Vaginal Symptoms (p < 0.001), with no significant differences between groups [s1].

All four also produced significant increases in tissue thickness (p < 0.001), number of epithelial layers (p < 0.001), and collagen quantity and depth (p < 0.001), again with no significant difference between the groups [s1].

The authors conclude that microablative and non-ablative energies, whether laser or radiofrequency, are effective for symptoms of genitourinary syndrome of menopause, with histological correlation and no notable efficacy difference between modalities [s1].

The comparison that is missing

There is no sham arm and no untreated control [s1]. Every participant received an active device. "All four improved and none beat the others" is therefore compatible with two very different underlying facts: that all four work about equally well, or that none of them does anything specific and all four groups improved for the reasons untreated groups improve — regression to the mean, repeated clinical attention, the lubricating effect of the procedure itself, and the well-documented placebo response in genitourinary symptom scales.

That is not a hypothetical concern here. The only large double-blind sham-controlled trial of a vaginal laser found no benefit. In 85 postmenopausal women randomised at a tertiary referral hospital in Sydney to three fractional CO2 laser treatments or three sham treatments, with 78 (91.7%) completing 12-month follow-up, there was no significant difference between groups in symptom severity on a visual analogue scale (change −17.2 with laser vs −26.6 with sham; difference 9.4, 95% CI −28.6 to 47.5) or on the Vulvovaginal Symptom Questionnaire (−3.1 vs −1.6; difference −1.5, 95% CI −5.9 to 3.0) [s2].

Notably, that trial also found no difference in histological comparisons between laser and sham groups [s2] — which complicates the inference that tissue change in the new trial demonstrates a device-specific effect.

The sham group in the Sydney trial improved substantially on its own. That is the number that makes an uncontrolled four-arm comparison hard to interpret.

Other limits

Forty-eight women split four ways gives twelve per arm [s1]. A trial that size can only detect very large differences between modalities; the finding of "no significant difference between groups" is close to guaranteed by the sample size regardless of the truth.

Follow-up was one month after the end of treatment [s1]. The Sydney trial's primary endpoint was at 12 months [s2]. Genitourinary syndrome of menopause is a chronic condition driven by ongoing oestrogen deficiency, and short-term symptom change is a weak guide to durable benefit.

The trial was single-blind, meaning participants were not blinded to which device they received [s1].

Why this keeps mattering

Energy-based vaginal treatments are typically paid for out of pocket and delivered in courses of several sessions. The evidence question — do they outperform sham — is therefore also a consumer protection question. A trial comparing four active devices at twelve patients per arm cannot answer it, however carefully conducted.

What the new trial does contribute is a genuine head-to-head signal: nothing in the data suggests one energy modality outperforms another, and non-ablative approaches performed no worse than microablative ones [s1]. If a device effect exists, this trial gives no reason to prefer the more aggressive version of it.

What to watch

Whether adequately powered sham-controlled trials with 12-month endpoints are conducted for radiofrequency, which has less sham-controlled evidence than laser; whether histological change without symptom separation from sham is replicated; and how professional societies weigh this literature in guidance on non-hormonal options.

This article describes randomised trial results and is informational only. It is not medical advice and does not recommend any device or procedure.

Sources

• [s1] Slongo H, Henriques DCP, Ongaratto APN, Machado HC, Triglia RM, Juliato CRT, Microablative and non-ablative laser and radiofrequency treatment of genitourinary syndrome of menopause: A randomised controlled trial with four different energies, Maturitas, 2025;202:108737, published online 2025-09-25.
• [s2] Li FG, Maheux-Lacroix S, Deans R, Nesbitt-Hawes E, Budden A, Nguyen K, Lim CY, Song S, McCormack L, Lyons SD, Segelov E, Abbott JA, Effect of Fractional Carbon Dioxide Laser vs Sham Treatment on Symptom Severity in Women With Postmenopausal Vaginal Symptoms: A Randomized Clinical Trial, JAMA, 2021;326:1381-1389, published 2021-10-01.