Highlight
- A Cochrane systematic review and meta-analysis evaluated the efficacy of vaginal lasers for treating women with stress urinary incontinence (SUI).
- The evidence is very uncertain about vaginal lasers’ ability to improve continence clinically compared to sham treatments, with no clear long-term benefits.
- Patient-reported symptom improvements were noted but did not meet the minimally clinically important difference threshold, indicating limited practical benefit.
- Vaginal laser therapy was well tolerated, with no major adverse events reported across studies.
Study Background
Stress urinary incontinence (SUI) is a prevalent condition among women characterized by involuntary leakage of urine during activities that increase intra-abdominal pressure, such as coughing, sneezing, or physical exertion. SUI significantly impairs quality of life and poses a substantial clinical burden, with many women seeking effective conservative or minimally invasive treatment options. Surgical interventions, though effective, can carry risks and recovery time, prompting interest in alternative therapies.
Recently, vaginal laser therapies—typically fractional CO2 or erbium lasers—have emerged as non-surgical modalities proposed to enhance vaginal tissue remodeling, improve urethral support, and thus reduce SUI symptoms. Although marketed widely, their efficacy and safety have not been definitively established through robust randomized controlled trials (RCTs).
Study Design
This study is an abridged Cochrane systematic review and meta-analysis including randomized controlled trials that enrolled women diagnosed with SUI and compared vaginal laser therapy against sham procedures, control groups, or topical treatments such as estrogen. The analysis incorporated nine RCTs encompassing 689 women. Endpoints evaluated included objective measures of continence, patient-reported symptom scores, and safety outcomes, focusing mainly on short-term follow-up data due to scarce long-term evidence.
Key Findings
The meta-analysis found that vaginal laser therapy might not differ significantly from sham treatments in increasing the proportion of women who were continent shortly after treatment. The pooled risk ratio was 1.50 (95% confidence interval [CI], 0.72–3.10), with high heterogeneity (I2 = 81%) across studies, reflecting considerable variability and very low certainty evidence.
Regarding patient-reported incontinence measures, vaginal laser therapy showed some improvement compared with sham, with a mean difference of -1.42 points (95% CI, -2.41 to -0.43) on validated symptom scales. However, this change did not reach the prespecified threshold for minimally clinically important difference, questioning the clinical relevance of this modest benefit.
Only one study compared vaginal laser to topical estrogen, limiting conclusions about relative efficacy. Notably, no major adverse events were reported with vaginal laser treatment or comparators at any follow-up point, supporting a favorable short-term safety profile.
Expert Commentary
The findings underscore the current uncertainty surrounding vaginal laser therapy’s effectiveness for SUI. The high heterogeneity and very low-certainty evidence stem from small sample sizes, short follow-up durations, and variations in laser types and treatment protocols. Clinicians should exercise caution in routinely recommending vaginal lasers for SUI until further high-quality, large-scale RCTs with longer follow-up validate their efficacy and durability of benefit.
From a mechanistic perspective, laser-induced collagen remodeling might theoretically improve urethral support, but optimal parameters, target populations, and comparative efficacy versus established therapies remain ill-defined. Furthermore, patient expectations need careful management given the modest symptom improvements and unclear clinical significance observed.
Conclusion
Vaginal laser therapy for stress urinary incontinence in women shows uncertain efficacy in improving continence objectively in the short term compared to sham or topical treatments. While patient-reported symptoms may improve slightly, these benefits may not translate to meaningful clinical differences. Importantly, vaginal lasers appear safe without major adverse events reported. Future research should prioritize adequately powered randomized trials with standardized protocols and long-term outcomes to clarify the role of vaginal lasers in SUI management. Clinicians should weigh these limitations when counseling patients on treatment options.
Funding and Trial Registration
The systematic review was published by Ippolito GM and colleagues in the Journal of Urology in 2025. Detailed funding sources were not specified in the abridged report. Clinical trial registration information was not provided.
References
Ippolito GM, Crescenze I, Sitto H, Palanjian RR, Raza D, Barboglio-Romo P, Wallace SA, Orozco Leal G, Clemens JQ, Dahm P, Gupta P. Vaginal Lasers for Treating Stress Urinary Incontinence in Women: An Abridged Cochrane Systematic Review and Meta-Analysis. J Urol. 2025 Nov;214(5):474-486. doi: 10.1097/JU.0000000000004691. PMID: 40920553.
