Does Vaginal Rejuvenation Really Work? A Complete Guide for Women

Ashley Harwyn, PA-C, ABAAHP  |  Published September 9, 2025  |  Last updated October 6, 2026  |  19 min read

Vaginal lasers have now been tested against convincing fake treatments. Here is what those trials found, and what to try before you book a device.

We first published this guide as a broad overview. For this update we rebuilt it around one question: what happened when lasers were tested against a convincing placebo, the way a new drug would be? We offer vaginal rejuvenation in Mount Pleasant, so we have every commercial reason to tell you it works. We would rather show you the trials, what they measured, and the treatments with stronger evidence behind them.

• In July 2018 the FDA warned that the safety and effectiveness of energy-based devices (commonly laser or radiofrequency) for vaginal “rejuvenation” “has not been established,” and said such treatments may lead to serious adverse events including burns, scarring, and painful sex.[1]
• Three double-blind trials of CO2 laser for menopausal vaginal symptoms or sexual function found no significant difference from sham treatment, including one that followed women for 12 months.[2][3][4]
• In those trials the sham groups improved too; in the Sydney trial, overall symptom scores fell more in the sham group than in the laser group.[2][4]
• For stress urinary incontinence, the largest double-blind Er:YAG trial found the laser no more effective than sham at 6 months, while a smaller single-blind trial, in which two of six authors reported research and speaker honoraria from the laser's maker, found a benefit.[6][7]
• Better-supported first steps exist: lubricants, moisturizers, low-dose vaginal estrogen, and other prescription options for menopausal symptoms, all graded Level A by The Menopause Society, and pelvic floor muscle training for stress leakage, backed by high-quality evidence in a Cochrane review.[8][10]
• The FDA advised patients to discuss the benefits and risks of all available treatment options for vaginal symptoms with their health care provider.[1]

What did the FDA actually warn about in 2018?

On July 30, 2018, the FDA issued a safety communication warning against the use of energy-based devices, commonly radiofrequency or laser, to perform vaginal “rejuvenation” or vaginal cosmetic procedures.[1] Its central sentence was blunt: the safety and effectiveness of these devices for those procedures “has not been established.” The agency warned that applying energy-based therapies to the vagina for these symptoms may lead to serious adverse events, including vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.[1]

The confusing part for patients is that the devices themselves had FDA clearance, for general gynecologic uses such as destroying abnormal or precancerous cervical or vaginal tissue and genital warts.[1] That clearance did not cover rejuvenation. The agency told patients directly that it had not cleared or approved any energy-based medical device for vaginal “rejuvenation” or for vaginal symptoms related to menopause, urinary incontinence, or sexual function.[1] So “this laser is FDA-cleared” and “this laser is FDA-cleared for vaginal rejuvenation” are two different sentences, and according to the 2018 communication, only the first one was true.

Two years later, the American College of Obstetricians and Gynecologists repeated the point in its committee opinion on elective genital cosmetic procedures, noting that the FDA had not cleared or approved any energy-based medical device for vaginal “rejuvenation” or for vaginal symptoms related to menopause, urinary incontinence, or sexual function.[9] The North American Menopause Society (now The Menopause Society) addressed the devices in its 2020 position statement. It concluded that there were insufficient placebo-controlled trials of energy-based therapies “to draw conclusions on efficacy and safety or to make treatment recommendations.”[8]

That statement grades its own advice. Its recommendations on lubricants, moisturizers, and low-dose vaginal estrogen earn its Level A grade, which it defines as supported by sufficient, consistent scientific evidence. Its line on lasers and radiofrequency devices, that they require long-term, sham-controlled safety and efficacy studies before their routine use can be recommended, is graded Level C, meaning based primarily on expert opinion.[8] Put simply, the statement rated its advice on the first-line treatments as backed by sufficient, consistent evidence, and its advice on devices as expert opinion.

Why is a sham-controlled trial the test that matters?

A sham treatment is designed to look and feel like the real procedure without delivering the active treatment. In a double-blind trial, neither the woman nor the people assessing her know which one she received. It plays the role that a sugar pill plays in a drug trial: it lets researchers separate the effect of the laser energy from the effect of everything else about being treated.

That matters here because the main outcomes in these trials are symptom scores that women rate themselves. In the 12-month Sydney trial, women in the sham group reported a larger average drop in overall vaginal symptoms on a 0 to 100 scale (26.6 points) than women who got the laser (17.2 points), and the difference between the groups was not statistically significant.[2] A study that measured only the laser group before and after treatment would have recorded an improvement, with no way to tell how much of it the laser caused.

The Menopause Society flagged this problem in 2020, noting that laser studies in breast cancer survivors generally had neither a positive nor a sham control, “a shortcoming of many of the studies on these devices.”[8] To be fair, the same statement acknowledged that data from small studies of fractional CO2 laser support improvement in vaginal dryness and painful sex.[8] Sham-controlled trials are how those small-study findings get tested.

How to judge any vaginal laser study in four questions

• Was there a sham group, or only a before-and-after comparison?
• Were the women and the people measuring results both blinded?
• How long were women followed: weeks, or a year?
• Who paid for the study, and did the authors report ties to the device maker?

What did the sham-controlled laser trials find?

Five sham-controlled trials published between 2021 and 2026 are the backbone of this review. Three tested CO2 lasers for menopausal vaginal symptoms or sexual function, and two tested Er:YAG lasers (the laser type that includes IntimaLase) for stress urinary incontinence. The table summarizes who took part, how long they were followed, and what each trial reported against sham.

Read across the menopause rows and a pattern appears. In Sydney, 85 women were randomized to three fractional CO2 treatments or sham, 78 completed a full year, and the authors concluded the laser “did not significantly improve vaginal symptoms after 12 months” compared with sham.[2] There were 16 adverse events in the laser group and 17 in the sham group, including vaginal pain or discomfort, spotting, discharge, and lower urinary tract symptoms, and no severe adverse events in either group.[2] In Belgium, each woman received both laser and sham in random order, and the response at 12 weeks was “comparable to that of sham applications.”[3]

The Barcelona trial matters for women who cannot or will not use estrogen. All 72 breast cancer survivors received a first-line routine of nonhormonal moisturizers and vaginal vibrator stimulation, and each was randomly assigned to laser or sham on top of that routine. Sexual function scores rose in both groups, from 14.8 to 20.0 points with laser and from 15.6 to 23.5 points with sham, with no significant difference between them.[4] Women also rated the laser as less tolerable than the sham.[4]

Pooled analysis tells a similar story with one wrinkle. A 2023 meta-analysis of 7 randomized trials comparing CO2 laser with sham, covering 407 women, found the two comparable for most measures, including sexual function scores, pain with intercourse, vaginal health scores, vaginal pH, and satisfaction. One symptom scale favored the laser, and the authors called it “promising” while saying further well-designed trials are needed.[5] We read that as an open question, not a proven treatment.

Can a vaginal laser fix bladder leakage?

Stress urinary incontinence is leakage when you cough, sneeze, laugh, or exercise. Lasers such as IntimaLase are marketed to stimulate collagen in the vaginal wall and improve mild leakage. Here the two sham-controlled trials cited in this guide point in opposite directions, and the details explain why we treat the question as unsettled.

The larger trial, a double-blind study at a single tertiary hospital led by researchers in Toronto, randomized 144 women to two Er:YAG laser sessions or two sham sessions. At 6 months there was no difference in the reported cure rate, which was close to zero in both groups. Apart from statistically significant differences at 6 weeks on 1 of 3 incontinence questionnaires and 3 of 9 quality-of-life domains, there were no significant differences between the groups, including on 24-hour pad tests that measure leaked urine. The authors concluded the laser “was no more effective than sham for curing or improving” stress incontinence at 6 months.[6]

The smaller trial, run in three urogynecology departments in the UK, Switzerland, and Germany, reported the opposite: 32 of 51 women (62.7%) given laser met its cure definition, at least a 50% reduction on a one-hour pad weigh test, compared with 4 of 23 (18.2%) given sham.[7] Three things temper that result. Only the patients were blinded, the sham group had 23 women, and two of the six authors reported research and speaker honoraria from Fotona, the company that makes the IntimaLase laser.[7] Industry ties do not make a result wrong. They do make independent replication important before anyone calls it proven.

Compare that with pelvic floor muscle training, a structured program of pelvic floor exercises. A Cochrane review of 31 trials found that women with stress incontinence who did the training were eight times more likely to report cure than women who received no treatment or an inactive control (56% versus 6%), and rated that finding high-quality evidence.[10] We walk through incontinence types and first-line care in our guide to urinary incontinence and vaginal laxity, and our IncontiLase page explains that laser option.

One gap is worth naming. None of the five trials in the table lists vaginal laxity among the outcomes in its published abstract, although improving laxity is one of the things IntimaLase is marketed for. These trials therefore cannot tell you that a laser reliably tightens the vagina, and you should be wary of any clinic in Charleston or elsewhere that promises it will.

If not a laser, what helps dryness and painful sex?

The symptoms many women hope a laser will fix, dryness, burning, irritation, and pain with sex after menopause, are part of a named condition: genitourinary syndrome of menopause, or GSM.[8] The Menopause Society estimates it affects approximately 27% to 84% of postmenopausal women, and notes that unlike hot flashes, which usually improve over time, it is generally progressive without effective therapy.[8] Its main treatments carry the statement's Level A grade.

The 2020 position statement lays out a stepwise plan, after other causes of symptoms are excluded:[8]

• First line, for less severe symptoms: a nonhormone lubricant during sex plus a long-acting vaginal moisturizer used regularly, several times a week (Level A).
• For moderate to severe symptoms, or when lubricants and moisturizers are not enough: low-dose vaginal estrogen, vaginal DHEA (prasterone), or ospemifene, an oral pill (each Level A).
• When hot flashes are also present: systemic estrogen therapy (Level A).
• For women with a history of breast or endometrial cancer: management depends on her preferences, how severe the symptoms are, and her understanding of the risks, after consultation with her oncologist (Level C).

If you are wary of vaginal estrogen because of the warnings attached to systemic hormone therapy, the same statement says those risks are highly unlikely with low-dose vaginal estrogen, given minimal systemic absorption and reassuring findings from trials and observational studies (Level B).[8] Our guide on whether vaginal estrogen is safe covers that evidence in detail. When hot flashes or night sweats come with the dryness, the statement lists systemic estrogen therapy as an option, and our bioidentical hormone therapy page covers that service. One more rule from the same statement: spotting or bleeding in a postmenopausal woman requires a thorough evaluation.[8]

Not sure whether your symptoms need a device at all? Call 843-981-0870 to book an exam, and ask what is causing the dryness, pain, or leakage and which treatment has the strongest evidence for it.

How should you weigh a vaginal rejuvenation offer in Charleston?

If you are considering a vaginal rejuvenation offer in Charleston or Mount Pleasant, a short, practical sequence of questions helps before you book anything.

• Name the symptom in plain words. Dryness, pain with sex, leakage with a cough, a looser feeling, or a concern about appearance each lead somewhere different.
• Ask what diagnosis the clinician suspects. The Menopause Society lists many conditions that can mimic GSM, including infections and skin conditions such as lichen sclerosus, and stress incontinence has its own first-line care.[8][10]
• Ask which sham-controlled trial supports the device for that exact symptom. If the answer is a before-and-after study or a brochure, you now know how to weigh it.
• Ask what you should try first, and for how long. The Menopause Society lists lubricants and moisturizers as first-line for GSM, and the Cochrane review found high-quality evidence for pelvic floor muscle training in stress incontinence.[8][10]
• Ask about harms in writing. The FDA said energy-based treatments for these purposes may lead to burns, scarring, painful sex, and recurring or chronic pain.[1]

Surgery deserves the same scrutiny. ACOG states that cosmetic genital surgery or procedures to alter sexual appearance or function, excluding procedures for clinical indications such as vaginal prolapse, incontinence, or a previous obstetric injury, are not medically indicated, pose substantial risk, and lack established safety and effectiveness.[9] It lists possible complications including pain, bleeding, infection, scarring, adhesions, altered sensation, painful sex, and the need for another operation.[9] ACOG also notes that a clinician can reassure a woman that the size, shape, and color of the external genitalia vary considerably from woman to woman.[9]

At Solcara Health we offer IntimaLase and the O-Shot, and our vaginal rejuvenation page describes the order we work in: an examination, a name for what is actually going on, the evidence-based treatment if there is a diagnosable condition, and only then any discussion of elective options, with realistic expectations explained. Solcara sees patients at our Mount Pleasant office on Bramson Court and at The Longevity Club on Rutledge Avenue in downtown Charleston. You can read more about Ashley and her training before you decide.

Ashley Harwyn, PA-C PA-C, ABAAHP · Founder, Solcara Health Online

Tap a question to ask

About the author

Ashley Harwyn, PA-C, ABAAHP

Founder, Solcara Health · Diplomate, American Board of Anti-Aging Health Practitioners (ABAAHP)

Ashley has practiced medicine for more than fifteen years. Her path into it began at home, with a family member born with a congenital heart defect and a childhood spent watching how much the quality of a clinician's attention could change the shape of a life. She has since practiced across a range of settings, including medical mission work in Uganda, before founding Solcara to build the kind of practice she kept wishing existed, one that treats patients as whole people and tells them the truth about what the evidence does and does not support.

Full bio →