Search Results (22)

Background and Objectives: This study aimed to assess whether the addition of fractional CO₂ laser therapy to standard pharmacologic treatment with Mirabegron, a β3-adrenoceptor agonist, enhances the clinical outcomes in the management of overactive bladder syndrome (OAB) in postmenopausal women. Materials and Methods: Τhis was a prospective, randomized, double-blind, sham-controlled trial including 50 postmenopausal women with moderate-to-severe OAB symptoms. Participants were randomized (1:1) to receive mirabegron 50 mg daily in combination with either active fractional CO₂ laser therapy (Group A) or sham laser treatment (Group B). Both groups underwent three monthly sessions of vaginal laser treatment and were followed for a total of four months. Clinical assessments were performed at baseline and monthly visits (T0–T3), using validated instruments including the Overactive Bladder Questionnaire (OAB-q), King’s Health Questionnaire (KHQ), Urinary Distress Inventory (UDI-6), Pelvic Floor Impact Questionnaire (PFIQ-7), Patient Global Impression of Improvement (PGI-I), and 3-day voiding diaries. The trial was registered at ClinicalTrials.gov (Identifier: NCT03846895). Results: Significant symptom improvement was observed within both groups over time, with reductions in urinary frequency, urgency, nocturia, and incontinence episodes, as well as improvements in quality-of-life scores. However, intergroup comparisons revealed no statistically significant differences in any primary or secondary outcomes. Both treatment modalities demonstrated similar effectiveness across all measured parameters. Conclusions: In this randomized controlled trial, the adjunctive use of fractional CO₂ laser therapy did not offer additional clinical benefit beyond mirabegron monotherapy in the short-term management of OAB. These findings underscore the need for further investigation into tailored therapeutic strategies, particularly in populations with overlapping genitourinary syndrome of menopause or more refractory OAB symptoms. Full article

Objectives: We aimed to study the efficacy of fractional CO₂ laser for genitourinary syndrome of menopause (GSM) symptoms in breast cancer (BC) survivors through a randomized, sham-controlled study, followed by an open-phase study assessing the impact of additional treatments. Methods: BC survivors with GSM were randomized to receive either three sessions of intravaginal CO₂ laser or sham treatment every 3–4 weeks. The laser’s energy was 45–60 mJ/pixel. Outcomes were compared one month following the last session. Participants initially receiving laser treatment were offered three more sessions, while those receiving sham had six laser sessions in an open-label study. Results: Thirty-four BC survivors were randomized to laser (n = 19) or sham (n = 15) treatments. Dyspareunia and intercourse dryness scores improved in both groups one month post-treatment, without a significant advantage of laser over sham. The laser treatment resulted in a reduction in daily dryness (−1.30 ± 0.55, p = 0.017), an increase in vaginal hydration (3.24 ± 1.13, p = 0.004), and an increase in Vaginal Health Index (VHI) (2.26 ± 0.50, p < 0.001). Most participants (18/19 and 9/15, respectively) opted to continue laser treatments after unblinding, resulting in 27 patients receiving six laser treatments. Increasing the number of laser treatments was associated with a constant improvement in Visual Analogue Score (VAS) scores for dyspareunia, intercourse dryness, daily dryness, burning, discomfort, itch, and average VAS, as well as pH, VHI, and hydration. Conclusions Three fractional CO₂ laser treatments for BC survivors reduced daily dryness but did not improve dyspareunia and sexual dryness when compared to sham in this randomized trial. Increasing the number of treatment sessions seemed to improve outcomes; however, it remained clinically insufficient, even after six treatments. Full article

Background: Genitourinary Syndrome of Menopause (GSM) is a prevalent condition in postmenopausal women characterized by symptoms such as vaginal dryness, itching, and urinary tract issues due to declining estrogen levels. Despite its widespread impact on quality of life, GSM often remains underdiagnosed and without effective treatment. Methods: This study assessed the long-term efficacy of fractional CO₂ laser treatment in alleviating GSM symptoms in perimenopausal women. The study involved 125 participants, with clinical evaluations conducted using vaginal pH, the Vaginal Health Index Score (VHIS), the Vaginal Maturation Index (VMI), and the Female Sexual Function Index (FSFI). Results: Results indicated significant improvements in these parameters, with pH levels decreasing, VHIS scores rising, and notable gains in VMI and FSFI observed up to 12 months post-treatment. This improvement has been validated through both subjective and objective assessments of GSM. Conclusions: The findings indicate that this method is effective and safe, with no significant side effects reported. However, conducting a long-term observational study on eventual longer protocol for maintaining the positive effect of this therapy should be conducted. Full article

This study aimed to investigate the efficacy and duration of multiple non-ablative intravaginal CO2 laser (V-lase^®) cycles in breast cancer patients, gynecological and other pelvic cancers previously subjected to multiple oncological treatments. This prospective study enrolled women under the age of 65 years who reported vaginal symptoms. Data on the Vaginal Health Index (VHI), vaginal length (VL), vaginal pain measured using a Visual Analog Scale (VAS), and the Female Sexual Function Index (FSFI) were collected at baseline and before each laser application, and at subsequent follow-up visits. A total of 170 laser applications were performed on 113 women with various types of cancer. Most patients (57.5%) had received radiotherapy-based treatments before receiving laser treatment. Vaginal health parameters and sexual function improved significantly with each laser application. However, a temporary decline in these improvements occurred during the intervals between cycles. Such worsening was reversed with the subsequent cycle in all groups of patients, irrespective of the type of oncological treatments they had undergone. Multiple course vaginal laser therapy showed promising results as a potential treatment for vaginal atrophy in heavily treated gynecological and breast cancer patients, necessitating further research to determine the optimal time interval between cycles to ensure sustained positive effects. Full article

Genitourinary syndrome of menopause (GSM) encompasses a range of distressing symptoms in the vulvovaginal and/or bladder–urethral regions related to menopause changes, negatively influencing woman’s quality of life and sexual activity. Fractional micro-ablative CO₂ laser therapy has shown the potential to reinstate the vaginal epithelium to a condition akin to the premenopausal state, thereby ameliorating the subjective symptoms associated with GSM. We conducted a prospective, pilot study in 73 sexually active postmenopausal women treated with CO₂ laser for their GSM symptoms, while assessing Vaginal Health Index Score (VHIS) and sexual function through the Female Sexual Function Index (FSFI) Questionnaire. The laser treatment resulted in a decrease in VHIS and patient-reported vulvovaginal atrophy (VVA) symptoms, with a significantly lower prevalence of vaginal itching, dryness, and burning (p < 0.001), as well as dyspareunia (p = 0.002). The occurrence of urinary incontinence, urgency, and vaginal heaviness significantly reduced, with an improvement in the staging of cystocele, either to Stage 1 or complete resolution (p < 0.001). FSFI total and domain scores were significantly higher after the treatment, indicating better sexual function, with a post-treatment score median of 25 (p < 0.001). Therefore, using a three-cycle fractional CO₂ laser was an effective choice for reducing urogenital discomfort related to GSM in postmenopausal women. Full article

Background and Objectives: Postmenopausal vaginal discomfort is often attributed to vulvovaginal atrophy (VVA). Women with VVA experience symptoms such as vaginal dryness, itching, burning, irritation, and dyspareunia. Materials and Methods: This pilot study was conducted to assess the effects of a micro-ablative fractional CO₂ laser on the clinical symptoms of VVA, as well as concordant sexual function. The severity of VVA symptoms was evaluated by a visual analogue scale (VAS), while the condition of the vaginal mucosa was evaluated using the Vaginal Health Index Score (VHSI). Sexual function was evaluated using the Female Sexual Function Index (FSFI) Questionnaire. Results: Our cohort included 84 sexually active postmenopausal women with bothersome VVA, leading to sexual health complaints. The mean age of the participants in our study was 55.2 ± 5.4 years, with an average postmenopausal period of 6 ± 4.8 years. The age of our patients and the length of their postmenopausal period exhibited a significant negative correlation with VHSI scores, while a longer postmenopausal period was associated with increased severity of vaginal dryness and dyspareunia. Baseline VHSI values showed that 65% of patients had atrophic vaginitis with pronounced VVA symptoms (70.2% experienced vaginal itching, 73.8% reported vaginal burning, 95.3% had vaginal dryness, and 86.1% suffered from dyspareunia). Lower VHSI values significantly correlated with lower FSFI scores, while more severe VVA symptoms scores correlated with lower FSFI scores. VVA symptoms were significantly less severe after treatment. VHIS regained high non-atrophic values in 98.8% of patients post-treatment (p < 0.001). FSFI total and domain scores were significantly higher after treatment (p < 0.001). Conclusions: Our study revealed that fractional CO₂ laser is a useful treatment option to alleviate VVA symptoms and improve vaginal health and sexual functioning in postmenopausal women. Full article

Background: This multicentric prospective study was carried out at Fondazione Policlinico Universitario Campus Bio Medico and Ospedale di Stato of St. Marino Republic. Between 1 January 2019, and 31 December 2022, all pre- and post-menopausal women diagnosed with recurrent, post-coital, and interstitial cystitis at both centers were included in the study. The main aim of the study was to assess the effectiveness of vaginal CO₂ laser treatment, alone or combined with intravesical hyaluronic acid instillations, in managing cystitis symptoms, such as dysuria, pollakiuria, and urgency, across the entire patient cohort. The secondary objective was to investigate the reduction in number of annual cystitis episodes post-treatment. Methods: Each woman underwent three to four sessions of micro-ablative CO₂ vaginal laser treatment. A follow-up examination was conducted 12 months after the final laser session (up to December 2023), during which a post-treatment VAS assessment evaluated dysuria, daily pollakiuria, and urgency. The enrolled patients recorded the number of cystitis episodes experienced during the 12-month pre- and post-treatment period. Results: Results indicated the laser’s efficacy in reducing the total number of cystitis episodes per year and an improvement in symptoms up to one year post-treatment. Greater efficacy of the CO₂ laser treatment, particularly when combined with intravesical hyaluronic acid instillation, was observed in both pre- and post- menopausal women. Conclusions: Fractional CO₂ laser therapy represents a safe and efficacious, non-hormonal approach for pre- and post-menopausal women diagnosed with recurrent, post-coital, and interstitial cystitis. Full article

Stress urinary incontinence (SUI) affects around 20% of women. In addition to the established suburethral sling insertion, two less invasive approaches are of interest today: urethral bulking agents and vaginal laser therapy. This review discusses articles through December 2023 identified by a PubMed literature search using the keywords “incontinence” and “bulking” or “laser”. Although the two approaches are less effective than sling insertions, there are specific conditions in which one or the other technique is more advantageous. Injecting bulking agents into the urethra only takes some minutes and works without general anesthesia. The method is particularly suited for elderly, frail, or obese patients with multiple comorbidities, but is also applicable for all patients and in combination with other therapies. Generally, the safety profile is good but differs between bulking materials. Two laser types—the Erbium:YAG laser with SMOOTH-mode and the fractional ablative CO₂ laser—deliver heat into the tissue to induce tissue tightening and regeneration. Intravaginal laser therapy improves mild to moderate SUI, while studies describe how intraurethral laser therapy is also beneficial for severe SUI. Young women between childbirths, as well as postmenopausal women, may benefit from laser therapy. The method is safe, can be performed on an outpatient basis, and does not require any artificial material. Full article

This study aimed to examine the impact of fractional CO₂ laser treatment of pelvic symptoms in women who have undergone perineal trauma from vaginal delivery. It was a retrospective, monocentric analysis that encompassed all women assessed for pelvic discomfort or signs of vulvovaginal atrophy following vaginal delivery between 2013 and 2018. The severity of symptoms was assessed using the Visual Analogue Scale (VAS). Twenty-seven patients met the inclusion criteria and were sorted into two groups: (1) women who had undergone episiotomies during labor (n = 11); and (2) women who had experienced spontaneous tears during vaginal delivery (n = 16). For women with episiotomies, each treatment and subsequent evaluation consistently showed a significant reduction in dyspareunia intensity. A similar positive trend was observed regarding pain at the introitus (7.5 vs. 6.5 after the first treatment, p = 0.03; 6.5 vs. 3 after the second treatment, p = 0.01; 3 vs. 1 after the third treatment, p = 0.01). Among women experiencing spontaneous perineal tears during delivery, there was a notable decrease in dyspareunia following all treatments (8 vs. 7 after the first treatment, p = 0.01; 8 vs. 4 after the second treatment, p = 0.02; 3 vs. 1 after the third treatment, p = 0.03). The impact of laser treatment did not exhibit significant differences between women who underwent episiotomies and those who experienced spontaneous perineal tears. In conclusion, fractional CO₂ laser can be regarded as a non-pharmacological option for managing pelvic floor symptoms in women who encountered perineal trauma during delivery, independently from the nature, spontaneity, or iatrogenesis of the perineal laceration. Full article

Background and Objectives: Genitourinary syndrome of menopause (GSM) affects more than half of postmenopausal women. This study aimed to evaluate the clinical and histological aspects of microablative fractionated CO₂ laser (CO₂L), microablative fractionated radiofrequency (RF) and intravaginal estrogen (ET) therapy as GSM treatments for the vulvar vestibule. Materials and Methods: This study included postmenopausal women with at least one moderate-to-severe complaint of GSM. Women in the CO₂L and RF groups received three monthly sessions of outpatient vulvovaginal therapy. The procedures were performed 30 min after applying 4% lidocaine gel to the vulva and vaginal introitus. Vulvar vestibular pain was assessed after each application using a 10-point VAS. A follow-up evaluation was performed 120 days after beginning each treatment. Digital images of the vulva were obtained and a 5-point Likert scale (1 = much worse, 2 = worse, 3 = neutral, 4 = better, 5 = much better) was used to assess the global post-treatment women’s impression of improvement regarding GSM. Results: A significant change in clinical aspects of the vulva was observed after all treatments with a reduction in the atrophic global vulvar aspect and an enhancement of the trophic aspect. High satisfaction was also reported after treatment according to the Likert scale evaluation: CO₂L (4.55 ± 0.97), RF (4.54 ± 0.95), CT (4 ± 1.41), p = 0.066. Histological evaluation revealed enhanced dermal papillae before pre-treatment, significantly reducing post-treatment in all groups (p = 0.002). No unintended effects were reported. Conclusions: CO₂L, RF, and ET significantly improved GSM concerning the vulvar vestibule at the 4 months follow-up. Full article

In the context of the menopausal transition, genitourinary syndrome of menopause (GSM) refers to a range of genitourinary symptoms, from vaginal dryness to dysuria and urinary urgency. While hormonal treatments are standard, their associated side effects have driven the exploration of alternatives like vaginal CO₂ laser. We aimed to evaluate the randomized controlled trials (RCTs) comparing vaginal CO₂ laser treatment for GSM to sham controls. This systematic review sourced four electronic databases until June 2023. The analysis incorporated seven RCTs with 407 women. The CO₂ laser and sham control were comparable for most parameters, including the female sexual function index (FSFI) and visual analogue scale (VAS) for dyspareunia, vaginal health index, pH, and patient satisfaction. However, the CO₂ laser group showed significant improvement in the vaginal assessment scale for GSM symptoms. Sensitivity analyses revealed that parameters like FSFI showed significant differences in favor of CO₂ laser group upon the exclusion of specific studies. In conclusion, vaginal CO₂ laser therapy emerges as a promising alternative for GSM management, especially for most bothersome GSM symptoms; however, the need for further well-designed RCTs remains to validate its broad safety and efficacy. Full article

Vaginal wall prolapse is the most common type of pelvic organ prolapse and is mainly associated with collagen bundle changes in the lamina propria. Neodymium (Nd:YAG) laser treatment was used as an innovative, minimally invasive and non-ablative procedure for the treatment of early-stage vaginal wall prolapse. The purpose of this pilot study was to assess connective tissue changes in the vaginal wall under prolapse without treatment and after Nd:YAG laser treatment using cross-polarization optical coherence tomography (CP OCT) with depth-resolved attenuation mapping. A total of 26 freshly excised samples of vaginal wall from 26 patients with age norm (n = 8), stage I–II prolapses without treatment (n = 8) and stage I–II prolapse 1–2 months after Nd:YAG laser treatment (n = 10) were assessed. As a result, for the first time, depth-resolved attenuation maps of the vaginal wall in the B-scan projection in the co- and cross-polarization channels were constructed. Two parameters within the lamina propria were target calculated: the median value and the percentages of high (≥4 mm⁻¹) and low (<4 mm⁻¹) attenuation coefficient values. A significant (p < 0.0001) decrease in the parameters in the case of vaginal wall prolapse compared to the age norm was identified. After laser treatment, a significant (p < 0.0001) increase in the parameters compared to the normal level was also observed. Notably, in the cross-channel, both parameters showed a greater difference between the groups than in the co-channel. Therefore, using the cross-channel achieved more reliable differentiation between the groups. To conclude, attenuation coefficient maps allow visualization and quantification of changes in the condition of the connective tissue of the vaginal wall. In the future, CP OCT could be used for in vivo detection of early-stage vaginal wall prolapse and for monitoring the effectiveness of treatment. Full article

Background: To compare the efficacy of CO₂ fractional laser with that of topical estriol for treating genitourinary syndrome of menopause and to investigate the relationship between epithelial thickness and vaginal atrophy. Methods: Twenty-five menopausal women were randomized to receive either laser or estrogen treatment. Vaginal biopsies before and after treatment were compared to assess the amount and distribution of estrogen and progesterone receptors. Results: Estrogen receptor levels were statistically similar between groups before and after treatment. Although there was no change over time in the estrogen group, an increase in receptor levels was confirmed in the laser group. Changes in estrogen receptor levels showed no association with treatment. Progesterone receptor levels were statistically similar between groups throughout treatment. There was no change over time in both groups. These changes displayed no association with the type of treatment. There was no significant correlation between epithelium thickness and estrogen or progesterone receptor levels. Conclusions: Estrogen and progesterone receptor levels increased and were maintained, respectively, in the vaginal epithelium in both groups. There was no significant relationship between epithelium thickness and receptor density. Laser therapy had similar outcomes to the gold standard without involving the disadvantages of hormone therapy. Full article

This study evaluates the efficacy and safety of fractional CO₂ lasers for treating genitourinary syndrome of menopause (GSM) in Korean women. The patients received three laser applications at an interval of 4 weeks each. The severity of GSM symptoms was assessed using a visual analog scale (VAS) at baseline and at every visit. The objective scale was measured using the vaginal health index score (VHIS) and Vaginal Maturation Index (VMI) after completion of the laser procedure. During each procedure, the patients’ pain in the VAS score was recorded. In the last visit, patients evaluated their satisfaction with the laser therapy using a 5-point Likert scale. Thirty women completed all the study protocols. After two sessions of laser therapy, some GSM symptoms (vaginal dryness and urgency) and VHIS improved significantly. After completion of the treatment, all GSM symptoms improved (p < 0.05), and the VHIS further increased significantly (VHIS at baseline, 8.86 ± 3.2 vs. V3, 16.83 ± 3.15, p < 0.001). The average satisfaction was 4.3. This study shows that fractional CO₂ laser treatment is effective and safe for Korean women with GSM. Further studies are needed to confirm these results and assess the long-term effects of laser therapy. Full article

The postmenopausal state covers 40% of modern women’s lives and 50–70% of postmenopausal women report GSM symptoms such as vaginal dryness, itching, frequent inflammations, lack of elasticity, or dyspareunia. Consequently, a safe and effective method of treatment is crucial. In a group of 125 patients, a prospective observational study was performed. The aim was to evaluate the clinical effectiveness of fractional CO₂ laser in the treatment of GSM symptoms using a protocol of three procedures in 6-week intervals. The vaginal pH, VHIS, VMI, FSFI, and treatment satisfaction questionnaire were used. The fractional CO₂ laser treatment was effective in improving all the objective forms of evaluation: vaginal pH (from 5.61 ± 0.50 at the baseline up to 4.69 ± 0.21 in the 6-week follow-up after the third procedure); VHIS (12.02 ± 1.89 at the baseline vs. 21.50 ± 1.76); VMI (21.5 ± 5.66 vs. 48.4 ± 4.46). Similar results were obtained for FSFI: 12.79 ± 5.351 vs. 24.39 ± 2.733, where 79.77% of patients were highly satisfied. Fractional CO₂ laser therapy increases the quality of life by having a beneficial effect on the sexual function of women with GSM symptoms. This effect is obtained by restoring the correct structure and proportions of the cellular composition of the vaginal epithelium. This positive effect was confirmed by both objective and subjective forms of evaluating GSM symptom severity. Full article