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Vaginal Laser Therapy

Vaginal laser therapy (fractional CO₂ or non-ablative Er:YAG) is an emerging, minimally invasive, nonhormonal energy-based treatment studied for genitourinary syndrome of menopause (GSM) or vulvovaginal atrophy (VVA), stress urinary incontinence (SUI), lichen sclerosus, and vaginal laxity. The evidence base remains limited by small sample sizes, short follow-up, and methodologic heterogeneity. The FDA has not approved or cleared energy-based vaginal devices for menopausal vaginal symptoms, urinary incontinence, or vaginal rejuvenation/cosmetic procedures, and issued a 2018 safety communication warning against use for "vaginal rejuvenation."[1][2][3][48]

For the broader female-SUI ladder, see Female Stress Incontinence Database. For the canonical GSM article, see GSM. For non-laser GSM alternatives, see Vaginal & Topical Estrogen, Vaginal DHEA (prasterone), and Ospemifene.

Laser Biophysics and Mechanism​

FeatureFractional CO₂ LaserNon-ablative Er:YAG Laser
Wavelength10,600 nm (far IR)2,940 nm (mid IR)
Tissue interactionMicroablative — fractionated columns of thermal injury surrounded by untreated tissueNon-ablative — thermal energy without epithelial ablation (SMOOTH mode)
Epithelial surfaceCreates micro-woundsPreserved
Commercial devicesMonaLisa Touch (DEKA / Cynosure), FemiLift (Alma), FemTouch (Lumenis)Fotona TimeWalker II IntimaLaser platform: IncontiLase (SUI), RenovaLase (GSM), IntimaLase (laxity)[57]

Small clinical and preclinical reports describe laser-associated tissue-remodeling responses; a 12-month sham-controlled CO₂ trial found no between-group histologic difference.[6][8][9][7][10] Proposed tissue responses include:

  1. Immediate. Thermal denaturation and contraction of existing collagen.
  2. Inflammatory (days). Inflammatory cell infiltration, fibroblast activation.
  3. Proposed remodeling (weeks–months). Neocollagenesis (types I and III), neoangiogenesis, increased glycogen-rich epithelial thickness, and increased HSP70 expression have been described in small clinical and preclinical studies.[7][8][9] Restoration of Lactobacillus-dominant flora remains unproven against sham: a 44-woman Er:YAG trial found no statistically significant lactobacilli-grade difference (5/20 laser versus 1/19 sham improved).[66]

Bretas 2022 documented a significant rise in collagen type III fibers (from 10.86 to 16.87) on histology after CO₂ treatment.[9] Preclinical porcine models confirmed dose-dependent increases in collagen and elastic fibers, capillary formation, and HSP70 / collagen I synthesis.[8] A systematic review of Er:YAG documented increased epithelial thickness, fibroblast proliferation, ECM production, and vascularization without epithelial ablation.[7]

Treatment Protocols​

Fractional CO₂ (MonaLisa Touch — most studied)​

  • Li 2021 trial settings (not a validated therapeutic regimen). 40 W power, 1000 μs dwell time, 1000 μm DOT spacing, SmartStack 2, DP emission, for a fluence of approximately 5.37 J/cm²; this sham-controlled protocol did not improve GSM symptoms over sham at 12 months.[10]
  • Protocol. 3 sessions, 4–8 weeks apart.[5][10]
  • Procedure. 360° rotating probe in the vaginal canal; circumferential firing covering the canal and introitus. In the Li 2021 CO₂-laser trial, topical 4% lidocaine was applied to the introitus for 20 min before treatment.[10]
  • Duration. 5–10 min per session.
  • Postprocedure. Abstain from intercourse 48–72 h.
  • Model-specific screening and safety. Cynosure Canada lists unevaluated treatment-area lesions, active genital infection, pregnancy or <3 months postpartum, prolapse beyond the hymen, prior vaginal or colorectal radiation, prior reconstructive pelvic surgery with mesh kits, impaired healing, keloids, and anticoagulation or thromboembolic disease as contraindications to SmartXide Touch therapy. Protective eyewear is required, smoke evacuation is advised when plume is present, and the probe, vaginal ring, and handpiece must be cleaned and disinfected or sterilized after every treatment.[51]

Non-ablative Er:YAG (IntimaLase — Fotona SMOOTH mode)​

  • Wavelength. 2,940 nm; non-ablative thermal-only ("SMOOTH") pulses heating tissue to approximately 60 °C.[7][36]
  • Energy in one combination protocol. Menkes 2026 used 4 J and approximately 3,600 pulses per session before applying intravaginal plant-derived exosomes in 20 women.[37]
  • Schedules studied. SUI trials included a single session and two-session courses four to six weeks apart; the cited vaginal tissue review also reports three sessions three weeks apart in a postmenopausal cohort.[5][7]
  • Procedure. With Fotona’s G-Set, IncontiLase (SUI) uses a 90° angular adapter; IntimaLase (laxity) and RenovaLase (GSM) use a 360° circular adapter. Non-ablative Er:YAG avoids CO₂-like microablative wounds.[7][52]
  • Duration. 15–20 min per session.
  • Anesthesia. Usually not required.
  • Histology. Gaspar 2020: vaginal epithelial thickness rose from 45 µm to 153 µm (range 97–244) at 3 mo in severe atrophy.[38]

Maintenance​

In a prospective cohort of 84 premenopausal women treated with CO₂ laser for vaginal laxity, FSFI and VHI gains waned by 6 months. The efficacy and interval of repeat sessions for vaginal laxity, GSM or SUI remain unestablished.[11][12]

Efficacy by Indication​

GSM / VVA​

The most studied indication; evidence depends heavily on study design.

  • Sham-controlled RCT (Li 2021 JAMA). Of 85 randomized women, 78 completed 12-month follow-up; symptom severity (VAS or VSQ) did not differ significantly between CO₂ laser and sham, and both groups improved substantially.[10]
  • Laser versus vaginal estrogen. Meta-analyses of 6–7 RCTs (270–302 women): no significant differences across VAS, VHI, VMI, FSFI, or urinary symptom scores.[13][14]
  • Slongo 2025. A four-arm RCT randomized 48 postmenopausal women with GSM to Er:YAG, CO₂, non-ablative radiofrequency or fractional radiofrequency.[15] Symptoms and histologic measures improved within each arm, with no significant between-arm difference one month after treatment.[15]
  • Zerzan 2025 VA SR of 11 low-to-moderate ROB RCTs: CO₂ versus sham may result in little to no difference in dysuria, dyspareunia, or QoL (low certainty); CO₂ versus vaginal estrogen also little to no difference.[16]
  • AUA/SUFU/AUGS 2025 guideline: counsels that the evidence does not support CO₂ laser, Er:YAG laser or radiofrequency for GSM-related dryness, discomfort, dysuria, dyspareunia, quality of life or satisfaction . As Expert Opinion (Statement 18), CO₂ laser only may be considered, in shared decision-making and with disclosure that it is experimental outside clinical trials, for GSM-related vulvovaginal dryness, discomfort/irritation, dysuria, and/or dyspareunia in patients who are not candidates for or prefer alternatives to FDA-approved treatments.[47] Statement 18 does not extend to Er:YAG or radiofrequency.[47]
  • Er:YAG-specific data. Avul 2023 retrospectively studied 32 women with GSM after three sessions: 84.4% reported complete or tolerable symptom regression, and 5/32 (15.6%) had transient mucosal injury (all recovered).[39] Lin 2022 retrospectively studied 64 postmenopausal women with GSM after three Er:YAG sessions, with follow-up scheduled at 12 months; the series reported within-group improvement in dryness, dyspareunia, itching, burning, ICIQ-SF, UDI-6, IIQ-7, OABSS, and POPDI-6 scores, as well as decreased vaginal pH.[40] Bayraktar 2024 sham-controlled pilot (n = 20) using shear-wave elastography demonstrated improved vaginal-wall elasticity (anterior 13.1 versus 20.0 kPa, p = 0.01; posterior 12.7 versus 19.4, p = 0.04) plus VHI, FSFI, and dyspareunia VAS gains in the laser arm.[41]

Stress Urinary Incontinence​

The strongest single-modality sham-controlled evidence in the vaginal-laser literature, but the largest trial is negative.

  • Cochrane 2025 (Ippolito; 9 RCTs, 689 women): very-low-certainty evidence did not establish a short-term difference in the number continent after laser versus sham or control (RR 1.50, 95% CI 0.72–3.10; 3 trials, 196 women).[5] Patient-reported ICIQ-UI SF differences were small (CO₂ MD −1.25; Er:YAG MD −1.60).[5]
  • Lukanović 2026 meta of 10 sham-controlled RCTs (approximately 850 women): pooled energy-device MD −1.08 ICIQ-UI SF (95% CI −2.08 to −0.08), statistically significant but modest; the laser-only estimate was −0.87 (95% CI −1.81 to 0.07). The laser-only confidence interval crosses zero.[17] Non-ablative Er:YAG showed the strongest, most homogeneous effect (MD −1.42; I² = 29%); CO₂ inconsistent.[17]
  • Phillips 2026 BJOG. In women with mild-to-moderate SUI, 32/51 laser recipients versus 4/23 sham recipients had a >50% reduction in 1-hour pad weight at 6 months (p < 0.001).[42]
  • O'Reilly 2024 IJGO multicenter sham-controlled Er:YAG RCT (110 recruited): at 6 mo, treatment success (>50% reduction in 1-hour pad weight) occurred in 33/56 (59%) laser versus 12/33 (36%) sham participants with pad-test data (OR 3.63, 95% CI 1.3–11.2, p = 0.02); KHQ and PISQ-12 improved versus sham.[43]
  • Lee 2025 AJOG double-blind sham-controlled Er:YAG RCT (n = 144): no significant difference for cure or improvement at 6 mo. The largest and most rigorous Er:YAG-SUI trial was negative.[44]
  • Yim 2025 multicenter sham-controlled Er:YAG cold-ablation RCT (75 randomized): primary and secondary SUI outcomes did not differ between arms at 6 or 12 months. This ablative mode was excluded from the non-ablative Er:YAG subgroup in Lukanović 2026.[17][63]
  • AUA / SUFU 2023 acknowledges laser as an "emerging therapy" but data are inconsistent and of poor quality, and references the FDA advisory.[18]
  • Laser versus pelvic-floor muscle training. A 60-woman Er:YAG trial found noninferior four-month UDI-6 change versus PFMT, but subjective cure was 3/28 versus 2/26 and most women sought other treatment by 24 months.[64] A 94-woman CO₂ trial found noninferior 12-month ICIQ-UI SF change within its prespecified margin; neither trial establishes superior objective continence or durable cure.[65]

Lichen Sclerosus​

  • Burkett 2021 RCT (n = 52): CO₂ versus clobetasol; at 6 mo, Skindex-29 improved more with laser (10.9-point effect, p = 0.007), and 81% versus 41% were satisfied (p = 0.01). The Skindex-29 subgroup difference was significant only among women previously exposed to steroids, but the interaction test was not significant.[19]
  • Zivanovic 2024 RCT (n = 66): Nd:YAG / Er:YAG dual laser versus clobetasol; greater objective LS clinical-score improvement with laser at 6 mo (−2.34 versus −0.95).[20]
  • Wei 2025 SR (7 RCTs, 332 patients): improvements in symptoms, signs, QoL and histology after laser; 3 studies favored laser over topical steroids; AEs were mild (5/147).[21] Evidence for laser as monotherapy remains limited.[21] In a double-blind sham-controlled trial, 40 women were randomized and 37 had post-treatment biopsies; no between-group difference in the histologic primary endpoint was detected after five fractional CO₂ laser or sham treatments over 24 weeks (P = .76).[53] A later open-label RCT randomized 245 women and found greater 3-month BIP symptom-score improvement with low-density fractional microablative CO₂ laser than with a tapered clobetasol regimen (median change −8 versus −5; p = 0.007); long-term disease control was not assessed at that endpoint.[50] Regardless of laser use, continue lichen-sclerosus follow-up with examination for precancerous or cancerous lesions; the German S3 guideline recommends review every 3–6 months initially and about annually once stable.[55]

Vaginal Laxity​

Observational studies show improvements in FSFI, VHI, and biomechanical parameters after CO₂.[22][23][24] Pereira 2024 pooled observational RF and laser studies and found a within-group FSFI increase (MD 6.51), but three RCTs did not confirm that sexual-function result. The pooled sham-controlled VLQ comparison was for RF, not laser, and found no clear advantage over sham.[25] Sathaworawong 2022 Er:YAG sham-controlled RCT (n = 42): tightness and overall satisfaction improved at 1 and 3 months, while pelvic-floor contraction was significantly better after the first treatment; sexual-sensation benefit averaged about 3 months.[45]

Efficacy Summary Table​

IndicationComparatorKey findingEvidence
GSM / VVAShamAcross four CO₂-versus-sham RCTs, little or no difference was detected in selected GSM outcomes; effects on dryness, discomfort, dyspareunia and satisfaction remain uncertain. The 12-month Li trial found no symptom-severity advantage.[10][16]Low to very low (outcome-dependent)
GSM / VVAVaginal estrogenNo significant difference (6 RCTs, 270 women)[13][14]Low–Moderate
GSM / VVAOther energy devicesNo between-arm difference detected at 1 month; equivalence and benefit over sham untested[15]Low (1 small RCT)
SUISham / controlShort-term continence uncertain (RR 1.50, 95% CI 0.72–3.10; 196 women); pooled energy-device ICIQ-UI SF MD −1.08 (below MID), with laser-only MD −0.87 (95% CI −1.81 to 0.07)[5][17]Very low (Cochrane outcomes)
Lichen sclerosusClobetasolLaser may be superior on some measures[19][20]Low (small RCTs)
Vaginal laxityShamObservational FSFI gains were not confirmed in pooled RCTs; one 42-woman Er:YAG sham trial reported improvement in tightness and satisfaction in the laser arm at 1 and 3 months[25][45]Very low
GSM in BCSVarious, including shamObservational studies report within-group VHI, dyspareunia, and dryness improvements.[26][27][28] LIGHT found no sexual-function or GSM advantage over sham at 6 months, and Jaber found no dyspareunia or intercourse-dryness advantage at 1 month, although daily dryness and VHI favored laser.[49][56]Low

Breast Cancer Survivors​

Nonhormonal treatments are first-line for GSM in breast cancer survivors, but low-dose vaginal estrogen may be considered after inadequate response, including during tamoxifen therapy; for aromatase-inhibitor users, ACOG calls for shared decision-making with the patient, gynecologist and oncologist.[30][47] Both CO₂ and Er:YAG have been studied here.[26][27][28][29][30]

  • Siliquini 2021 retrospective (n = 135; 45 BCS / 90 controls): significant VHI, dyspareunia, and dryness improvement in both groups after CO₂, lasting 12 mo, but slower in BCS than healthy women.[27]
  • Sham-controlled data. In LIGHT, 72 aromatase-inhibitor users were analyzed (35 CO₂ laser, 37 sham); both groups used moisturizers and vibrator stimulation, and sexual function and GSM outcomes did not differ between groups at 6 months.[56] Jaber 2025 randomized 34 breast cancer survivors (19 CO₂ laser, 15 sham); dyspareunia and intercourse dryness improved in both groups one month after three sessions, without significant laser advantage. Daily dryness, vaginal hydration, and VHI favored laser as short-term secondary outcomes in this small trial.[49] Serquiz 2026 reviewed three small RCTs (185 survivors): laser and radiofrequency groups reported GSM symptom improvement and few adverse events, but confidence in the evidence ranged from low to critically low.[26]
  • Lőczi 2024 BCS-specific meta. Seven laser studies (207 women) reported a pooled within-group VHI increase of 8.24 points (95% CI 4.57–11.92).[28]
  • ACOG 2021 Clinical Consensus: laser has shown promise in BCS but is not FDA-approved or FDA-cleared, lacks consistent training or certification, is costly and uncovered by insurance, and warrants additional research before recommending.[30]

Safety and Adverse Events​

  • AEs typically mild and transient: vaginal discharge, mild burning, spotting, swelling, transient dysuria.[1][31]
  • In a dual-wavelength diode-laser VVA study (30 recruited; 29 completed), mean procedural pain VAS was 1.6 / 10.[33]
  • In a 2022 review, 99 studies including 51,094 patients gave no information on severe adverse events, and 11 studies gave no adverse-event information at all. Two other studies reported five severe cases, including fibrosis, scarring, agglutination, penetration injury, vaginal shortening, and a transvaginal septum.[32]
  • Gambacciani 2020. A survey of 535 Er:YAG practitioners reported 113,174 treated patients, but only 188 practitioners supplied adverse-event frequency data for 43,095 patients.[46] Reported events in that subset were mild to moderate and transient.[46]
  • FDA MAUDE database (Oct 2015 – Jan 2019). 45 distinct AE reports (46 patients). Most common complaint: pain (n = 19). 33 patients reported chronic injuries including long-term pain, numbness, burning, bladder disturbances, infections, scarring, dyspareunia, worsening symptoms, disfigurement.[34]

The Er:YAG practitioner survey recorded adverse-event frequencies for 43,095 of 113,174 reported patients; MAUDE reports document persistent injuries without a treated-population denominator. Neither source estimates the incidence of uncommon serious harm or establishes a difference by operator or modality.[46][34]

FDA Warning (July 2018)​

The FDA issued a safety communication warning against energy-based devices for "vaginal rejuvenation," citing potential for vaginal burns, scarring, dyspareunia, and chronic pain. No energy-based device has been cleared or approved by the FDA for vaginal rejuvenation, cosmetic vaginal procedures, or treatment of GSM, SUI, or sexual function.[48][2][3]

Society Positions​

OrganizationPosition
US FDA (2018)[48]Safety warning; no device approved / cleared for GSM, SUI, or vaginal rejuvenation
ACOG (2020)[2]Cosmetic genital procedures lack established safety and effectiveness; counsel about limited evidence and potential complications. The opinion reports the FDA research-protocol warning for energy-based cosmetic vaginal procedures.
ACOG (2021, BCS Consensus)[30]Promising in research; not FDA-approved; additional research warranted
AUA / SUFU (2023)[18]Emerging therapy; data inconsistent and poor quality; extensive counseling required
AUA / SUFU / AUGS (2025, GSM)[47]Evidence does not support CO₂ laser, Er:YAG laser or radiofrequency for GSM ; CO₂ laser alone may be considered as Expert Opinion for patients who are not candidates for, or prefer alternatives to, FDA-approved treatments, with shared decision-making and disclosure that it is experimental outside trials
EAU (2026, SUI)[61]Do not offer vaginal laser for SUI symptoms except in a well-regulated, closely monitored research study
VA/DoD (2026, GSM)[62]Suggest against vaginal lasers for GSM (Weak against)
ESSM (2020)[3]Too early for decisive recommendations; properly designed RCTs urgently needed
EUGA Working Group (2023)[4]Both Er:YAG and CO₂ are safe energy-based options for GSM; more data needed
Iglesia 2024 Obstet Gynecol Expert Series[1]Evidence weak; most trials underpowered; cannot recommend for SUI

CO₂ vs Er:YAG — Head-to-Head​

FeatureFractional CO₂Non-ablative Er:YAG
Wavelength10,600 nm2,940 nm
Tissue interactionMicroablativeNon-ablative
Epithelial surfaceMicro-woundsPreserved
AnesthesiaTopical lidocaineUsually none
Sessions3 sessions, 4–8 wk apart1–3 sessions, 4–6 wk apart
GSM versus vaginal estrogenNo significant difference detected in short-term CO₂ comparisons; equivalence not established[14][16]Evidence insufficient to claim equivalence[16]
SUI efficacyInconsistent across RCTsMost consistent (MD −1.42)[17]
Lichen sclerosusRCT data (CO₂ and dual laser)RCT data (Nd:YAG / Er:YAG dual)
Direct head-to-head (Li 2023)—Larger 3-month UDI-6 / IIQ-7 improvements with Er:YAG in a retrospective comparison; causal or objective continence superiority untested[35]

Li 2023 retrospective comparison (n = 139): Er:YAG was associated with larger UDI-6 and IIQ-7 symptom-score improvements than CO₂ at 3 months, and two-session groups had larger improvements than one-session groups.[35]

Critical Appraisal​

The defining tension in the vaginal laser literature is the discrepancy between observational and sham-controlled data. Observational studies report 75–100% symptom reduction, while the highest-quality sham-controlled RCT (Li 2021 JAMA) showed no benefit over sham at 12 months for GSM.[10][32] This pattern suggests a substantial placebo or expectation effect and supports the need for sham controls.

Limitations of the current evidence:[1][3][12][32]

  • Most studies small (n < 100) and uncontrolled.
  • Heterogeneous protocols, devices, and outcome measures.
  • Short follow-up (most < 12 months).
  • A 2020 US cost-effectiveness model for CO₂ laser in GSM-associated dyspareunia estimated $2,733 out of pocket for three sessions.[32]
  • In one 84-woman premenopausal laxity cohort, score gains waned by 6 months. A separate SUI trial reported longer composite continence after CO₂ laser than sham over 48 months, with declining continence rates; the need for repeat sessions remains unestablished by indication.[11][58]

In breast cancer survivors with GSM, sham-controlled trials have not established CO₂ laser benefit over sham.[26][49] For vulvar lichen sclerosus, potent topical corticosteroids remain standard: EuroGuiDerm 2024 does not recommend laser, whereas German S3 2026 gives an open "may be considered" option for fractionated ablative CO₂ or non-ablative Nd:YAG in women.[54][55] For SUI, AUA/SUFU 2023 describes laser as emerging and calls for extensive counseling about immature evidence, whereas NICE permits it only in research.[18][60] NICE 2024 permits vaginal laser for menopausal genitourinary symptoms only in a randomized trial.[59] ACOG 2020 addresses cosmetic vaginal procedures when citing research-protocol restrictions; FDA warns about injuries and device marketing, and ESSM calls for well-designed trials.[2][48][3] For GSM-related vulvovaginal dryness, discomfort/irritation, dysuria, and/or dyspareunia, AUA / SUFU / AUGS 2025 advises that evidence does not support CO₂ laser, Er:YAG laser, or radiofrequency, but permits consideration of experimental CO₂ laser through shared decision-making for patients who are not candidates for or prefer alternatives to FDA-approved therapies.[1][18][47][48][3][30]

Summary​

Small clinical and preclinical studies associate fractional CO₂ and non-ablative Er:YAG lasers with tissue-remodeling markers.[7][8][9][10] The Li 2021 sham-controlled RCT found no significant GSM symptom advantage at 12 months; Cochrane 2025 and Lukanović 2026 synthesize SUI trials and found small or uncertain average differences in patient-reported incontinence. Short-term laser-versus-estrogen trials detected no significant difference.[10][5][17][14] Lichen-sclerosus trials show mixed short-term results, with no established long-term disease control; vaginal-laxity evidence remains sparse.[19][20][25][50][53] In its 2018 safety communication, the FDA stated that no energy-based vaginal device was cleared or approved for menopausal vaginal symptoms, urinary incontinence, or cosmetic vaginal procedures.[48] For GSM, the 2025 AUA/SUFU/AUGS guideline says evidence does not support CO₂ laser, Er:YAG laser, or radiofrequency , but permits consideration of experimental CO₂ laser through shared decision-making for GSM-related vulvovaginal dryness, discomfort/irritation, dysuria, and/or dyspareunia in patients who are not candidates for, or prefer alternatives to, FDA-approved treatments .[47] ACOG allows low-dose vaginal estrogen after nonhormonal measures fail and risks and benefits are discussed, including during tamoxifen therapy; with aromatase inhibitors, it calls for shared decision-making among the patient, gynecologist, and oncologist.[30]

References​

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19. Burkett LS, Siddique M, Zeymo A, et al. Clobetasol compared with fractionated carbon dioxide laser for lichen sclerosus: a randomized controlled trial. Obstet Gynecol. 2021;137(6):968-978. doi:10.1097/AOG.0000000000004332.

20. Zivanovic I, Gamper M, Fesslmeier D, et al. Nd:YAG/Er:YAG dual laser compared with topical steroid to treat vulvar lichen sclerosus: a randomised controlled trial. BJOG. 2024;131(6):740-749. doi:10.1111/1471-0528.17737.

21. Wei D, Meng J, Li Q, et al. Efficacy and safety of laser treatment in vulvar lichen sclerosus: a systematic review. Lasers Surg Med. 2025;57(10):760-770. doi:10.1002/lsm.70062.

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23. Lauterbach R, Gutzeit O, Matanes E, et al. Vaginal fractional carbon dioxide laser treatment and changes in vaginal biomechanical parameters. Lasers Surg Med. 2021;53(9):1146-1151. doi:10.1002/lsm.23405.

24. Gao L, Wen W, Wang Y, et al. Fractional carbon dioxide laser improves vaginal laxity via remodeling of vaginal tissues in Asian women. J Clin Med. 2022;11(17):5201. doi:10.3390/jcm11175201.

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