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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) / 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. Critically, the FDA has not approved or cleared any energy-based device for these specific indications, and issued a 2018 safety communication warning against use for "vaginal rejuvenation."[1][2][3]

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)IntimaLase (Fotona)

Both lasers initiate a tissue-remodeling cascade that reverses the histologic hallmarks of vaginal atrophy:[6][8][9][7]

  1. Immediate — thermal denaturation and contraction of existing collagen.
  2. Inflammatory (days) — inflammatory cell infiltration, fibroblast activation.
  3. Remodeling (weeks–months) — neocollagenesis (types I and III), neoangiogenesis, increased glycogen-rich epithelial thickness, restoration of Lactobacillus-dominant flora, increased HSP70 expression.

Bretas 2022 documented a significant rise in collagen type III fibers (10.86 → 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)​

  • Settings — 40 W power, 1000 μs dwell time, 1000 μm DOT spacing, SmartStack 2, DP emission → fluence ~ 5.37 J/cm².[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. Topical 4% lidocaine to the introitus 20 min prior.
  • Duration — 5–10 min / session.
  • Postprocedure — abstain from intercourse 48–72 h.

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

  • Wavelength — 2,940 nm; non-ablative thermal-only ("SMOOTH") pulses heating tissue to ~ 60 °C.[7][36]
  • Energy — typically 4 J / pulse, ~ 3,600 pulses per session.[37]
  • Protocol — 2–4 sessions, 4–6 weeks apart.[5][7]
  • Procedure — 360° vaginal probe; epithelium partially preserved (no microablative wounds, vs CO₂).[7]
  • Duration — 15–20 min / session.
  • Anesthesia — usually not required.
  • Histology — Gaspar 2020: vaginal epithelial thickness 45 µm → 153 µm (range 97–244) at 3 mo in severe atrophy.[38]

Maintenance​

Benefits appear to wane by 6–12 months, suggesting maintenance sessions every 6–12 mo may be needed.[11][12]

Efficacy by Indication​

GSM / VVA​

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

  • Sham-controlled RCT — Li 2021 JAMA (n = 85, 12 mo): no significant difference in symptom severity (VAS or VSQ) between CO₂ laser and sham; both groups improved substantially → substantial sham effect.[10]
  • Laser vs 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 4-arm RCT (n = 48): Er:YAG, CO₂, non-ablative RF, and fractional RF — all four equivalent in symptom and histologic improvement.[15]
  • Zerzan 2025 VA SR of 11 low-to-moderate ROB RCTs: CO₂ vs sham may result in little to no difference in dysuria, dyspareunia, or QoL (low certainty); CO₂ vs vaginal estrogen also little to no difference.[16]
  • Er:YAG-specific data — Avul 2023 (n = 64) showed significant 12-month improvement in dryness / dyspareunia / itching / burning and urinary scores (ICIQ-SF, UDI-6, IIQ-7, OABSS, POPDI-6); transient mucosal injury 15.6% (all recovered).[39] Lin 2022 (n = 32) showed significant pH reduction.[40] Bayraktar 2024 sham-controlled pilot (n = 20) using shear-wave elastography demonstrated improved vaginal-wall elasticity (anterior 13.1 vs 20.0 kPa, p = 0.01; posterior 12.7 vs 19.4, p = 0.04) plus VHI / FSFI / 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, 7 sham-controlled): lasers may improve patient-reported incontinence on ICIQ-UI SF (CO₂ MD −1.25; Er:YAG MD −1.60), but the point estimates and CIs do not meet the 5-point minimal clinically important difference.[5]
  • Lukanović 2026 meta of 10 sham-controlled RCTs (~ 850 women): pooled MD −1.08 ICIQ-UI SF (95% CI −2.08 to −0.08) — statistically significant but modest. Non-ablative Er:YAG showed the strongest, most homogeneous effect (MD −1.42; I² = 29%); CO₂ inconsistent.[17]
  • Phillips 2025 BJOG multicenter sham-controlled Er:YAG RCT (n = 79): 62.7% cure in laser vs 18.2% sham (p < 0.05).[42]
  • O'Reilly 2024 IJGO multicenter sham-controlled Er:YAG RCT (n = 110): treatment success 59% vs 36% (OR 3.63, 95% CI 1.3–11.2, p = 0.02); significant KHQ and PISQ-12 improvement.[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 — and it was negative.[44]
  • AUA / SUFU 2023 acknowledges laser as an "emerging therapy" but data are inconsistent and of poor quality, and references the FDA advisory.[18]

Lichen Sclerosus​

  • Burkett 2021 RCT (n = 52): CO₂ vs clobetasol — greater Skindex-29 improvement with laser (10.9-point effect, p = 0.007); 81% satisfied with laser vs 41% with steroid (p = 0.01); benefit greatest in patients previously exposed to steroids.[19]
  • Zivanovic 2024 RCT (n = 66): Nd:YAG / Er:YAG dual laser vs clobetasol — greater objective LS clinical-score improvement with laser (−2.34 vs −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 mild (5 / 147). Evidence for laser as monotherapy remains limited.[21]

Vaginal Laxity​

Observational studies show improvements in FSFI, VHI, and biomechanical parameters after CO₂.[22][23][24] Pereira 2024 SR / meta: while observational studies showed improved sexual function (FSFI MD 6.51), RCTs did not confirm vaginal-tightening (VLQ) benefit vs sham.[25] Sathaworawong 2022 Er:YAG sham-controlled RCT (n = 42): significant tightness-satisfaction and pelvic-floor-contraction improvement at 1 and 3 months — but effects were transient (~ 3 months).[45]

Efficacy Summary Table​

IndicationComparatorKey findingEvidence
GSM / VVAShamNo significant difference at 12 mo[10]Moderate (1 RCT)
GSM / VVAVaginal estrogenNo significant difference (6 RCTs, 270 women)[13][14]Low–Moderate
GSM / VVAOther energy devicesAll modalities equivalent[15]Low (1 RCT)
SUIShamModest improvement (MD −1.08 ICIQ-UI SF); below MID[5][17]Low–Moderate
Lichen sclerosusClobetasolLaser may be superior on some measures[19][20]Low (small RCTs)
Vaginal laxityShamObservational benefit; not confirmed in RCTs[25]Very low
GSM in BCSVariousImprovements in VHI, dyspareunia, dryness[26][27][28]Low

Breast Cancer Survivors​

A particularly important target population given that estrogen-based therapies are generally avoided. 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 / dryness improvement in both groups after CO₂, lasting 12 mo, but slower in BCS than healthy women.[27]
  • Serquiz 2026 SR of 3 RCTs (185 BCS): laser and RF improved GSM symptoms with minimal AEs, but evidence confidence was low and critical across all studies.[26]
  • Lőczi 2024 BCS-specific meta: significant VHI improvement (MD 8.24).[28]
  • ACOG 2021 Clinical Consensus: laser has shown promise in BCS but is not FDA-approved / not FDA-cleared, lacks consistent training / 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]
  • Procedural pain low (mean VAS ~ 1.6 / 10).[33]
  • 99-study review (n = 51,094): no serious AEs.[32]
  • Gambacciani 2020 — global Er:YAG safety survey of 535 practitioners covering 113,174 patients (2012–2019): all observed AEs were mild to moderate, transient, and at low frequencies; no serious AEs reported. The largest single safety dataset for any vaginal laser.[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 discrepancy between the very large Er:YAG safety dataset (113,000+ no serious AEs) and the MAUDE chronic-injury reports likely reflects (a) reporting-bias asymmetries (registry vs voluntary post-market surveillance) and (b) differences in modality and operator skill across the broader energy-based-device category. Counsel patients in both directions.

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.[2][3]

Society Positions​

OrganizationPosition
US FDA (2018)[2]Safety warning; no device approved / cleared for GSM, SUI, or vaginal rejuvenation
ACOG (2020)[1]Laser should not be used outside standardized research protocols for 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
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 efficacyComparable to vaginal estrogenComparable to vaginal estrogen
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)—Er:YAG more effective on UDI-6 / IIQ-7 at 3 mo[35]

Li 2023 retrospective comparison (n = 139): Er:YAG more effective than CO₂ for SUI (UDI-6 / IIQ-7) at 3 mo regardless of session number; 2 sessions > 1 session for both lasers.[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 / expectation effect and underscores the need for sham controls.

Key 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).
  • Cost ($500–1,500 per session, typically not insurance-covered).
  • Benefits wane by 6–12 mo, requiring maintenance.

Despite these limits, vaginal laser therapy may occupy a niche as a nonhormonal alternative for patients who cannot or will not use estrogen — particularly breast cancer survivors — and for lichen sclerosus refractory to topical steroids. Current FDA, ACOG, AUA / SUFU, and ESSM guidance uniformly recommends use within research protocols or with extensive patient counseling about the immaturity of the data.[1][18][2][3][30]

Summary​

Fractional CO₂ and non-ablative Er:YAG vaginal laser therapy are biologically plausible nonhormonal energy-based treatments that produce neocollagenesis, neoangiogenesis, and restoration of vaginal flora. Modern sham-controlled RCTs (Li 2021 JAMA; Cochrane 2025; Lukanović 2026) show that benefits over sham are modest and frequently below the minimum clinically important difference, while head-to-head trials against vaginal estrogen show no significant difference. Lichen sclerosus has the most encouraging RCT data; vaginal laxity has the weakest. The FDA has not approved or cleared any device for these indications; use should be restricted to research protocols or carefully counseled patients (especially BCS) for whom estrogen is contraindicated.[1][2][5][10][17][18][30]

References​

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41. Bayraktar E, Erel CT, Akturk H, et al. A novel objective evaluation method, shear wave elastography, in the treatment of atrophic vaginitis by nonablative intravaginal Er:YAG laser, a randomized-sham controlled pilot study. Menopause. 2024;31(8):716-723. doi:10.1097/GME.0000000000002380.

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