Fractional carbon dioxide (fCO2) has been suggested to alleviate urinary symptoms, such as frequency, urgency, urge urinary incontinence (UUI), and stress urinary incontinence (SUI) given its therapeutic effects on genitourinary symptoms of menopause (GSM). The laser’s thermal effect is purported to induce tissue remodeling and neovascularization of the vaginal lamina propria layer, thereby, strengthening urethral support and vaginal health. In a previous pilot study, we did not observe objective or subjective improvement in SUI at 6 months; however, there was a trend towards improvement for UUI. The aim of this study was to measure the effect of vaginal fCO2 laser therapy on SUI and OAB symptoms at 18 months.

After IRB approval, women > 18 years with urogenital symptoms were enrolled in an open-label prospective trial. Those with pelvic mesh, prior genital cancer, undiagnosed vaginal or cervical lesions or bleeding, radiation to the pelvic area, active vaginal infections, prior vaginal laser treatment within 12 months, active UTI, recent pelvic or vaginal surgery within 9 months, ˃ Stage 2 prolapse, or pregnant were excluded. A 3-month washout period was mandated for patients previously on vaginal estrogen therapy. The AcuPulse® FemTouchTM (Lumenis®, Israel) vaginal laser was used, which delivers low energy pulse of CO2 (wavelength= 10.6 µm) to the vaginal mucosa in a circumferential- every 60°- and longitudinal - every 1 cm - manner. Energy levels and power density are based on manufacturer guidelines. After the initial visit to establish baseline parameters, participants underwent 3 laser treatments, each 6 weeks apart from the previous. Optional treatment sessions at 1-, 2-, and 3- years are offered to all participants. Follow up visits were scheduled at 6-, 9-, 12-, and 18 months after the third treatment. Cough stress test was performed at all treatment and follow up visits, while a voiding diary was completed at baseline, 6- and 12-months. Subjective data was collected using the Incontinence-Quality of Life (I-QOL), Overactive Bladder Questionnaire short form (OABq-SF), Questionnaire for Urinary Incontinence Diagnosis (QUID) at 6-, 12-, and 18-months. ANOVA analysis with Dunnett’s multiple comparison was used to compare means at each time point.  Primary outcome was the subjective effects of fCO2 on overall urogenital symptoms.

At time of analysis, 92 patients were enrolled. Of these, 55 patients had 6-month data, 41 had 12-month data, and 29 had 18-month data.  At baseline, patients reported SUI (n=29; 31.5%), frequency (n=43; 46.7%), urgency (n=50; 54.3%), or UUI (n=35; 38%). There was no statistically significant difference in number of SUI leaks (2.23 leaks/d vs 1.4 leaks/d, p=0.1115) or rates of positive CST over time; however, there was improvement on the QUID SUI sub-section (p<0.0001) at 6, 12 and 18 months, figure 2. Compared to baseline on the 3-day voiding diary, no significant objective changes in frequency (11.1 voids/d vs 10.7 voids/d) or UUI episodes (2.1 episodes/d vs 1.1 voids/d) were seen at 12 months, but urge intensity was significantly decreased at that timepoint (1.5 vs 1.3, p=0.0445). This correlated with a similar improvement in the OABq-SF (p < 0.0001) and QUID UUI subsection (p= 0.0001) up to 18 months. Overall, there is significant improvement on the I-QOL (p<0.0001) for the entire cohort at 6, 12 and 18 months.

Preliminary analysis suggests that though vaginal fCO2 laser therapy did not improve objective SUI cure rates, patient-reported symptoms did improve over time.  Moreover, there was a significant reduction in urge intensity which parallels the patient’s subjective experience up to 18 months after onset of treatment.

Vaginal fCO2 laser may be a viable treatment option for women with GSM who suffer from urinary urgency and, possibly, SUI. Ongoing work for long-term data may shed further light.