Rezultate clinice și referitoare la funcția sexuală după terapia intravaginală cu laser diodă de 1470 nm pentru sindromul genitourinar al menopauzei: studiu-pilot prospectiv

Introduction

Genitourinary syndrome of menopause (GSM) is a chronic and progressive condition resulting from estrogen deficiency, and encompasses a spectrum of vulvovaginal and lower urinary tract symptoms, including vaginal dryness, burning, irritation, dyspareunia and recurrent urinary discomfort^(1,2). It is estimated to affect approximately 40-50% of postmenopausal women, yet it remains underdiagnosed and undertreated due to symptom normalization, embarrassment and limited awareness of therapeutic options⁽³⁾. GSM has a substantial negative impact on sexual health, intimate relationships and overall quality of life. The pathophysiology of GSM is characterized by thinning of the vaginal epithelium, reduced glycogen content, alterations in the vaginal microbiome, degradation of collagen and elastin fibers, and diminished vascularity of the vaginal mucosa⁽⁴⁾. These structural and biochemical changes lead to reduced lubrication, increased tissue fragility and heightened susceptibility to pain and inflammation. Importantly, genitourinary syndrome of menopause is a chronic condition that tends to worsen over time in the absence of treatment, distinguishing it from transient menopausal symptoms such as vasomotor instability⁽⁵⁾. Current management strategies for GSM include vaginal moisturizers, lubricants and local estrogen therapy. Vaginal estrogen remains an effective treatment for many women; however, its use may be limited by contraindications, concerns regarding long-term hormonal exposure, poor adherence or patient preference for nonhormonal therapies^(6,7). In recent years, there has been increasing demand for nonhormonal, minimally invasive treatment options that aim to restore vaginal tissue structure and function rather than provide symptomatic relief alone. Energy-based vaginal therapies have emerged as potential regenerative modalities by delivering controlled thermal energy to the vaginal mucosa, thereby activating wound-healing pathways and promoting extracellular matrix remodeling^(8,9). Laser-based systems have been shown to induce collagen neosynthesis, angiogenesis and epithelial regeneration, resulting in improvements in vaginal health indices and patient-reported outcomes. Among these technologies, near-infrared diode lasers operating at a wavelength of 1470 nm are of particular interest due to their high absorption in water-rich tissues, allowing precise thermal deposition with limited penetration depth and a favorable safety profile⁽¹⁰⁾. Beyond clinical symptom improvement, recent translational research has provided mechanistic insight into the biological effects of 1470-nm laser therapy on vaginal tissue. Multi-omics analyses integrating transcriptomic, proteomic and metabolomic data have demonstrated upregulation of pathways associated with collagen synthesis, angiogenesis and tissue remodeling following treatment, including transforming growth factor b-mediated signaling and extracellular matrix reorganization. These findings support the concept that laser-induced thermal stimulation may promote biologically mediated restoration of vaginal tissue integrity rather than transient symptomatic effects alone. Despite the growing interest and the emerging mechanistic evidence, clinical data evaluating the role of 1470-nm diode laser therapy specifically in women with GSM remain limited, particularly in prospective observational cohorts and real-world clinical settings. Moreover, sexual function outcomes are inconsistently reported, despite their central relevance to patient quality of life. The present prospective pilot study was therefore undertaken to evaluate the clinical outcomes, sexual function effects and safety of intravaginal 1470-nm diode laser therapy in postmenopausal women with genitourinary syndrome of menopause. By assessing symptom severity, vaginal health indices and validated sexual function measures, this study aims to contribute preliminary clinical evidence to inform future randomized controlled trials and refine patient selection for nonhormonal GSM therapies.

Methodology

Study design and setting

This prospective, single-center, observational pilot study was conducted at a private tertiary-level gynecology hospital between October 2025 and January 2026. The study evaluated the clinical outcomes, sexual function effects and safety of intravaginal 1470-nm diode laser therapy in postmenopausal women diagnosed with genitourinary syndrome of menopause (GSM).

Ethical considerations

The study protocol was reviewed and approved by the Institutional Ethics Committee of the hospital. The written informed consent was obtained from all participants prior to enrollment. The study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines.

Study population

Postmenopausal women presenting to the gynecology outpatient department with symptoms consistent with GSM were screened for eligibility.

Inclusion criteria:

• Natural or surgical menopause (≥12 months of amenorrhea).
• Presence of at least one moderate to severe GSM-related symptom (vaginal dryness, burning or dyspareunia).
• Baseline Vaginal Health Index (VHI) score ≤15.
• Willingness to comply with the study protocol and follow-up visits.

Exclusion criteria:

• Active vaginal or urinary tract infection at enrollment.
• Use of systemic or local estrogen therapy within the preceding three months.
• Prior vaginal energy-based treatment.
• Pelvic organ prolapse stage 2 or higher.
• History of pelvic malignancy or pelvic radiation.
• Pregnancy or breastfeeding.

A total of 25 eligible women were enrolled in the study.

Results

Participant characteristics

A total of 25 postmenopausal women with genitourinary syndrome of menopause completed the study protocol. The mean age was 56.8±6.2 years old, and the mean duration since menopause was 7.4±3.1 years. Fifteen participants (60%) were sexually active and included in the sexual function analysis. Baseline Vaginal Health Index (VHI) scores indicated moderate to severe vaginal atrophy in the study population. The baseline demographic and clinical characteristics are summarized in Table 1.

Changes in GSM-related symptoms

At the three-month follow-up, a significant improvement was observed in all assessed GSM-related symptoms compared with baseline. Mean vaginal dryness scores decreased from 7.8±1.1 to 3.2±1.2, burning scores decreased from 6.2±1.4 to 2.9±1.1, and the dyspareunia scores decreased from 7.1±1.3 to 3.1±1.2 (all p<0.001). The changes in GSM symptom severity scores are presented in Table 2.

Vaginal Health Index outcomes

Mean VHI scores increased significantly from baseline to three months post-treatment (12.1±2.3 versus 19.8±2.6; p<0.001), reflecting improvement in vaginal elasticity, epithelial integrity, moisture and pH. The VHI outcomes are detailed in Table 3 and illustrated graphically in Figure 1.

Bars represent mean values, and error bars indicate standard deviation.

A statistically significant increase in VHI score was observed at three months compared with baseline (p<0.001).

Sexual function outcomes

Among sexually active participants (n=15), total FSFI scores demonstrated a statistically significant improvement at three months compared with baseline (18.6±4.1 versus 26.7±4.6; p<0.001). The sexual function outcomes are summarized in Table 3.

Safety outcomes

No serious adverse events were reported during the study period. Mild, transient warmth or discomfort during the procedure was reported by four participants (16%) and resolved spontaneously without medical intervention. No cases of infection, bleeding or prolonged pain were observed.

Discussion

This prospective pilot study demonstrates that intravaginal 1470-nm diode laser therapy is associated with significant short-term improvement in core clinical manifestations of genitourinary syndrome of menopause (GSM), objective vaginal health parameters and sexual function in postmenopausal women. Improvements were consistent across symptom severity scores, Vaginal Health Index (VHI) and Female Sexual Function Index (FSFI), suggesting a convergent therapeutic effect on both tissue integrity and functional outcomes. The pathophysiology of GSM is characterized by hypoestrogenism-induced epithelial thinning, loss of collagen and elastin, reduced vascularity and impaired extracellular matrix turnover, leading to elevated vaginal pH, dryness and dyspareunia⁽¹⁾. While local estrogen therapy remains the standard of care, a substantial proportion of women seek nonhormonal alternatives due to contraindications, safety concerns or preference for nonpharmacologic interventions⁽²⁾. Energy-based vaginal therapies have therefore gained attention as a potential modality to induce tissue regeneration through controlled thermal stimulation rather than hormonal signaling⁽³⁾. The significant increase in VHI observed in this study reflects meaningful improvement in vaginal elasticity, epithelial maturation and hydration. These clinical findings are biologically plausible given prior mechanistic studies of 1470-nm laser technology, which have demonstrated selective photothermal interaction with water-rich tissues, leading to activation of fibroblasts, neocollagenesis, neoangiogenesis and remodeling of the extracellular matrix⁽⁴⁾. Such tissue-level changes provide a rational explanation for the observed symptomatic improvement and support the concept that energy-based therapy may partially reverse GSM-associated vaginal atrophy rather than merely providing transient symptom relief. Sexual function outcomes showed significant improvement in total FSFI scores among sexually active participants, with prominent gains in lubrication and pain domains. Dyspareunia in GSM is multifactorial, arising from epithelial fragility, reduced lubrication, altered vaginal compliance and neurovascular changes⁽⁵⁾. The improvement in these domains following laser therapy suggests that restoration of vaginal tissue quality may translate into clinically meaningful benefits in sexual health and quality of life. These findings are consistent with previously published observational studies reporting improved sexual function following vaginal energy-based treatments, although comparative data across different technologies remain limited⁽⁶⁾. Safety is a critical consideration in the evaluation of vaginal energy-based devices. In the present study, no serious adverse events were observed, and the reported procedural discomfort was mild and self-limiting. While this short-term safety profile is reassuring, regulatory bodies and professional societies have emphasized the need for robust clinical evidence, long-term follow-up and standardized outcome reporting in this field⁽⁷⁾. The absence of long-term safety and durability data remains an important knowledge gap. Several limitations should be acknowledged. This study was designed as a pilot investigation with a limited sample size, short follow-up and lack of a control or sham comparator, which restrict causal inference and generalizability. The outcomes were primarily based on validated clinical indices and patient-reported measures, without histological or molecular correlates. Nevertheless, the consistency of improvement across multiple independent outcome measures supports the internal validity of the findings and provides a strong rationale for further investigation. In conclusion, this pilot study provides preliminary clinical evidence that intravaginal 1470-nm diode laser therapy may improve the GSM symptoms, vaginal health and sexual function in postmenopausal women through nonhormonal tissue-regenerative mechanisms. Well-designed randomized controlled trials incorporating longer follow-up and mechanistic endpoints are essential to define its role within evidence-based GSM management.

Conclusions

This prospective pilot study demonstrates that intravaginal 1470-nm diode laser therapy is associated with significant short-term improvement in genitourinary syndrome of menopause-related symptoms, vaginal health and sexual function in postmenopausal women. Improvements were observed consistently across validated symptom severity scores, Vaginal Health Index and Female Sexual Function Index, with a favorable short-term safety profile. While these findings support the potential role of nonhormonal, energy-based interventions in the management of GSM, the results should be interpreted within the context of a pilot study design. Larger randomized controlled trials with longer follow-up and mechanistic endpoints are required to confirm the durability, safety and comparative effectiveness before routine clinical adoption.

Acknowledgement. The author acknowledges the technical support provided for the intravaginal laser platform (Viona, Bionique Meditech) used in this study. The manufacturer had no role in study design, patient selection, data collection, data analysis and the interpretation of results, manuscript preparation or the decision to submit the manuscript for publication. All clinical procedures, analyses and reporting were conducted independently by the author.

Acknowledgement. Acknowledged in preliminary studies.

Autor corespondent:  Smit Bharat Solanki E-mail: drsmitbharat@gmail.com

CONFLICT OF INTEREST: none declared.

FINANCIAL SUPPORT: none declared.

This work is permanently accessible online free of charge and published under the CC-BY.