Reviewed by Ashley Harwyn, PA-C, ABAAHP | A4M Board Certified | Updated October 2, 2026
IncontiLase is an Er:YAG laser marketed as a proven fix for leaking. Here is what the evidence actually shows, why it is not FDA-cleared, and the treatments that work.
That does not mean it can never help anyone. The fair summary is “unproven,” and before an elective laser you should know that the proven treatments for stress incontinence, starting with pelvic floor muscle training, are better studied, often more effective, and usually far less expensive. Where the hormonal changes of menopause are part of the picture, hormone therapy can help as well. We do offer IncontiLase at Solcara, which is exactly why we want you to see its evidence first.
- IncontiLase is a non-ablative Er:YAG laser aimed at the vaginal wall, marketed to tighten supporting tissue and reduce stress urinary incontinence. It is not FDA-approved or FDA-cleared for incontinence.[1]
- The FDA issued a safety communication warning against energy-based devices for urinary incontinence and similar uses, citing reports of burns, scarring, and chronic pain.[1]
- The evidence is mixed. Two sham-controlled trials at three months and a 2026 trial at six months were positive, but the single most rigorous trial, a double-blind study of 144 women with six-month follow-up, found the laser no more effective than a sham procedure.[2][3][4][6]
- Pelvic floor muscle training is first-line, and a Cochrane review of 31 trials and 1,817 women concluded we can be confident it cures or improves stress incontinence.[5]
- For the right candidate, a pessary or a mid-urethral sling are established, effective options with far more evidence than laser.[5]
- The smartest first step is an evaluation, not a laser, because the cause and severity decide which treatment actually fits.
What IncontiLase actually is
IncontiLase is a brand name for a non-ablative Er:YAG laser protocol delivered through the vagina, marketed to heat and tighten the tissue that supports the urethra and, in theory, to reduce leaking during a cough, sneeze, or jump. Using a laser rather than surgery sounds elegant and low-risk, and the sessions are quick. Firming tissue with laser energy sounds sensible, and that intuition is what the advertising leans on. Plausible is not the same as proven, and this is where the evidence gets uncomfortable for the industry.
Start with the regulatory status, because a sales page will blur it. The FDA has not cleared or approved any energy-based device, laser or radiofrequency, to treat urinary incontinence. In a 2018 safety communication the agency went further and warned patients directly that these devices were being marketed for uses the FDA had never evaluated, and that treating incontinence by applying energy to the vagina can lead to serious harm, including vaginal burns, scarring, and recurring pain.[1] So any clinic describing IncontiLase as an FDA-approved treatment for incontinence is misstating the facts. The honest framing is that this is an off-label, elective use of a laser.
What the evidence on laser for stress incontinence really shows
Clinic pages for this laser rarely show the trial results below. There are good sham-controlled trials of Er:YAG laser for stress urinary incontinence, and they do not all agree, which by itself tells you the treatment is not settled science.
Most of the encouraging trials are short. A 2018 randomized trial of 114 premenopausal women treated with the IncontiLase protocol found that at three months the laser group improved significantly more than the sham group on a validated incontinence questionnaire, with 21 percent of laser patients dry compared with 4 percent of sham patients.[3] A 2025 multicenter trial of 126 women was also positive on its main success measure at three months.[4] Both are real results worth knowing. Both also followed women for only three months, and in the 2025 trial the quality-of-life and symptom questionnaires improved in the sham group too, with no meaningful difference between laser and sham on those measures, a pattern that points to a strong placebo effect.[4] A 2026 multicenter trial that enrolled 79 women in the UK, Switzerland, and Germany followed them for six months: 62.7 percent of laser patients met its cure definition, at least a 50 percent drop on a one-hour pad test, against 18.2 percent on sham. Only the patients were blinded, and two of its six authors reported research and speaker fees from Fotona, the company that makes IncontiLase.[6]
Then there is the trial that matters most. A 2024 double-blind, sham-controlled study of 144 women, the most rigorous design in this field, found that the Er:YAG laser was no more effective than the sham procedure for curing or improving stress urinary incontinence.[2] The reported cure rate was near zero in both groups. In plain terms, the women who got a convincing fake treatment did just as well as the women who got the real laser. When you put the trials side by side, the honest summary is that any benefit is uncertain and vanished in the best-designed study. Anyone promising you reliable, long-lasting results is going well past the data.
Pelvic floor muscle training (first-line, with a Cochrane review confident it cures or improves), a fitted pessary, weight loss where relevant, and a mid-urethral sling for appropriate candidates, each with real, established evidence.
A non-ablative laser that is not FDA-cleared for incontinence, with mixed trials and a negative result in the single most rigorous study, marketed as revolutionary and proven.
IncontiLase compared with proven treatments
With the evidence laid out, IncontiLase lines up against the established options on what matters most: whether it is proven, whether it is FDA-cleared, and what role it realistically plays. The table below compares them honestly.
| Option | Evidence and approval | Honest role |
|---|---|---|
| IncontiLase (Er:YAG laser) | Mixed short-term trials, best one negative; not FDA-cleared; FDA warned against energy devices for incontinence | Unproven; elective, realistic expectations only |
| Pelvic floor muscle training | Strong evidence, Cochrane review confident it cures or improves | First-line, proven, low-cost starting point |
| Pessary | Established, effective support device for many women | Proven non-surgical option |
| Mid-urethral sling surgery | Well studied, high cure rates for appropriate candidates | Proven option when conservative care is not enough |
Six questions about your leakage
Check whatever applies. More checks mean a proper evaluation and the proven treatments should come before an elective laser.
Two things stand out when you read it honestly. Conservative treatments carry the strongest evidence and usually the lowest cost; the laser has neither advantage. Second, none of this matters until someone has evaluated your type and severity of incontinence, because that is what decides which treatment fits.
The treatments that are actually proven
A practice that sells the laser has little reason to put this front and center. Stress incontinence has treatments with genuinely strong evidence, and most people should try them before an elective laser.
Pelvic floor muscle training comes first. A Cochrane systematic review of 31 trials and 1,817 women concluded that we can be confident pelvic floor muscle training cures or improves stress incontinence, reduces leakage episodes, and improves quality of life, which is why it belongs in first-line care.[5] It costs little, carries essentially no risk, and done properly it works for a large share of women. A pessary, a small support device fitted in the office, is another proven and reversible option. And for women whose leaking is more severe or who have not improved with conservative care, a mid-urethral sling is one of the most studied procedures in gynecology, with high cure rates for the right candidate.[5]
Weight loss, bladder habits, and a review of medications and other contributors round out the picture, and the hormonal changes of menopause can play a role worth addressing with hormone therapy where appropriate. Where an elective option is genuinely what you want, the O-Shot and IncontiLase are both available here, and we will discuss them candidly as the unproven options they are, with realistic expectations, not as guaranteed cures. But they come after the evaluation and the proven treatments, not instead of them.
Tired of planning your day around the nearest bathroom? That is worth a real evaluation, not just a laser. Call 843-981-0870 and we will pin down the type and severity of your leakage and begin with the treatment best supported for it.
Stress incontinence care in Mount Pleasant and Charleston
If IncontiLase is what brought you here, the place to start is an evaluation, not a laser appointment. That evaluation sorts out the type and severity of your incontinence, looks at contributors from childbirth to menopause to medications, starts the proven treatment that fits, and only then weighs elective options against the trial data.
That is the sequence we follow at Solcara. A simple bladder diary kept for a few days before your visit, noting when leaks happen and what you were doing, makes the first appointment far more productive. Pelvic health visits are available in Mount Pleasant and at our downtown Longevity Club location. Ashley Harwyn, PA-C will tell you plainly where the evidence is thin, and if IncontiLase is still your choice after that, it is offered as an elective, unproven option rather than a cure.
Medical Weight Management
Losing excess weight can reduce the leaking of stress incontinence. Read Medical Weight Management.
Bioidentical Hormone Therapy
For the hormonal changes that can contribute to symptoms. Read Bioidentical Hormone Therapy.
Full Panel Lab Testing
Where a thorough evaluation of your overall health starts. Read Full Panel Lab Testing.
Ashley Harwyn, PA-C
PA-C, ABAAHP · Founder, Solcara Health
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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 women as whole people and tells them the truth about what the evidence does and does not support.
Full bio →References
The FDA 2018 safety communication on energy-based vaginal devices, a double-blind sham-controlled Er:YAG laser trial (AJOG 2025), two sham-controlled laser trials with positive short-term results (2018 and 2025), and the Cochrane review of pelvic floor muscle training, each accessed October 2, 2026.
- U.S. Food and Drug Administration. FDA Warns Against Use of Energy-Based Devices to Perform Vaginal 'Rejuvenation' or Vaginal Cosmetic Procedures: FDA Safety Communication. July 30, 2018. FDA.gov Archive copy. fda.gov
- Lee P, Perruzza D, Edell H, et al. Double-blind randomized controlled trial of Er:YAG vaginal laser to treat female stress urinary incontinence. American Journal of Obstetrics & Gynecology. 2025;232(6):541.e1-541.e12. pubmed.ncbi.nlm.nih.gov
- Blaganje M, Scepanovic D, Zgur L, et al. Non-ablative Er:YAG laser therapy effect on stress urinary incontinence related to quality of life and sexual function: A randomized controlled trial. European Journal of Obstetrics & Gynecology and Reproductive Biology. 2018;224:153-158. pubmed.ncbi.nlm.nih.gov
- Wang X, Zhang Z, Meng L, et al. Efficacy and safety of non-ablative ErYAG laser for mild to moderate stress urinary incontinence: a prospective, multicenter, randomized, sham-controlled clinical trial. Lasers in Medical Science. 2025;40(1):195. pubmed.ncbi.nlm.nih.gov
- Cacciari LP, Dumoulin C, Hay-Smith EJ. Pelvic floor muscle training versus no treatment, or inactive control treatments, for urinary incontinence in women: a Cochrane systematic review abridged republication. Brazilian Journal of Physical Therapy. 2019;23(2):93-107. pubmed.ncbi.nlm.nih.gov
- Phillips C, Shah G, Gamper M, et al. Vaginal Erbium Laser for the Treatment of Mild-to-Moderate Stress Urinary Incontinence: A Multicentre Randomised Sham-Controlled Trial. BJOG. 2026;133(4):609-617. pubmed.ncbi.nlm.nih.gov
Medical Disclaimer: This page is for educational and informational purposes only and does not constitute medical advice, and reading it does not create a patient-provider relationship. It describes general medical information and categories of care, not a recommendation that any individual start, stop, or change any test, treatment, or medication. Any diagnosis or treatment decision requires evaluation by a qualified, licensed clinician who knows your personal and family history. Consult a qualified healthcare provider before making medical decisions. Information reflects sources available as of October 2, 2026.
Ashley Harwyn, PA-C, ABAAHP, is a Diplomate of the American Board of Anti-Aging Health Practitioners (ABAAHP) through A4M and the founder of Solcara Health. Solcara serves South Carolina from Downtown Charleston (163 Rutledge Ave, Ste 202, The Longevity Club) and Mt. Pleasant (496 Bramson Ct, Ste 120).




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