The study presents an assessment of mechanism of action and a pilot clinical study of efficacy and safety of the Er:YAG laser for the treatment of stress urinary incontinence (SUI). The subject of this study is a treatment of SUI with a 2940 nm Er:YAG laser, operating in a special SMOOTH mode designed to increase temperature of the vaginal mucosa up to maximally 60–65 °C without ablating the epidermis. Numerical modelling of the temperature distribution within mucosa tissue following an irradiation with the SMOOTH mode Er:YAG laser was performed in order to determine the appropriate range of laser parameters. The laser treatment parameters were further confirmed by measuring in vivo temperatures of the vaginal mucosa using a thermal camera. To investigate the clinical efficacy and safety of the SMOOTH mode Er:YAG laser SUI treatment, a pilot clinical study was performed. The study recruited 31 female patients suffering from SUI. Follow-ups were scheduled at 1, 2, and 6 months post treatment. ICIQ-UI questionnaires were collected as a primary trial endpoint. Secondary endpoints included perineometry and residual urine volume measurements at baseline and all follow-ups. Thermal camera measurements have shown the optimal increase in temperature of the vaginal mucosa following treatment of SUI with a SMOOTH mode Er:YAG laser. Primary endpoint, the change in ICIQ-UI score, showed clinically relevant and statistically significant improvement after all follow-ups compared to baseline scores. There was also improvement in the secondary endpoints. Only mild and transient adverse events and no serious adverse events were reported. The results indicate that non-ablative Er:YAG laser therapy is a promising minimally invasive non-surgical option for treating women with SUI symptoms.
Introduction: Vaginal laxity drastically impairs women's quality of life, suggesting there is a need for effective noninvasive treatments. Aim: The aim was to retrospectively assess the effectiveness and safety of a nonablative Er:YAG IntimaLase laser procedure for vaginal laxity in patients treated in our clinical practice during a 2.5-year period. Methods: Laser treatment for vaginal laxity was performed using an intravaginal nonablative Er:YAG laser. Effectiveness was assessed using a Patient Satisfaction Questionnaire and also by independent evaluation of before and after treatment photographs of the patients' introitus. The safety and tolerability of the procedure was monitored in all patients. Main Outcome Measure: The study showed an improvement of sexual gratification and improvement of vaginal tightness, as assessed by patients. The tightness of the introitus was also improved, as assessed by independent evaluators. Results: As assessed by the Patient Satisfaction Questionnaire, we show that 92.7% of patients experienced improvement of sexual gratification after IntimaLase laser treatment. The results of the visual evaluation of the grade of laxity improvement in the introitus area, when open introitus photos were evaluated, show that 69% (n ¼ 20/29) of patients had an improvement of laxity. Nonablative Er:YAG treatment seems to be an effective and safe treatment for vaginal laxity. As it is a noninvasive procedure, it should be considered before any vaginoplasty surgery. The study included all the patients treated in clinical practice and observed very few adverse effects. The results were comparable with other published data. Because it is a retrospective study, there is a lack of a control group. Conclusion: The results have confirmed that patients suffering from vaginal laxity can be effectively treated using the nonablative Er:YAG IntimaLase procedure without adverse effects.
Aims: This prospective study aimed to compare the clinical outcomes between the use of Erbium:YAG (Er:YAG) laser in a nonablative mode, to the use of the pharmacological treatment of oral tadalafil for the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Methods: The laser group received two sessions of Erbium:YAG laser, administered intraurethrally in a long, nonablative train of long pulses (SMOOTH™ mode), applied at the level of the male prostatic urethra. Tadalafil group received oral tadalafil at a dose of 5 mg/day, consecutively for 2 months. Effectiveness was assessed using the International Prostate Symptom Score (IPSS) questionnaire, VAS (visual analogue scale) pain score, and maximum urethral flow at follow-up visits up to 12 months after initiating treatment. Adverse effects were recorded after each treatment and follow-up sessions. Results: The results show a significant decrease in the IPSS score in both groups up to the 12-month follow-up. The increase in Q-max was evident up to 3-months follow-up in the tadalafil group and up to 6 months in the laser group. The decrease in the VAS pain score was also significant in both treatment groups, lasting up to 3 months in the tadalafil group and up to 6 months in the laser group. Conclusions: The nonablative Er:YAG SMOOTH™ laser seems to be a promising treatment for this widely occurring condition. More studies are needed to confirm its safety and efficacy. K E Y W O R D S chronic prostatitis with chronic pelvic pain syndrome, nonablative Er:YAG laser therapy, tadalafil
The purpose of this study was to evaluate the safety and efficacy of a new combined method of Q-S laser-assisted tattoo removal. Ten patients with 13 professional, mostly mono-chromatic black tattoos were recruited. All tattoos received the same Q-S laser treatment sequence. An objective evaluation of tattoo clearing was assessed by careful analysis of a standardized collection of digital images taken from each tattoo, 2 months after each laser session, with the help of a custom-made pigment-fading percentage photographic ruler. The percentages of pigment clearance and side effects were evaluated by 4 independent dermatologists. Patient satisfaction and perceived discomfort during and post-procedure were evaluated according to specific scales. Clinical evaluators confirmed an average photographic pigment clearance of 97% after a median 4.85 treatment sessions. The Frac-Tat® method required 40% fewer sessions compared to those calculated by Kirby-Desai estimates. Photographic assessment of laser-exposed skin quality performed 2 months after tattoo clearing was considered almost comparable with untreated peripheral skin, confirming a very low side effect score. The Frac-Tat QS laser-assisted tattoo removal sequence used in our study showed a high degree of safety and efficiency, clearing exogenous pigments in a relatively few number of sessions. Preliminary ablative photo-acoustic fractional 1064-nm Q-S laser micro-drilling was considered an essential step in optimizing tattoo removal, increasing wavelength-independent micro-columnar clearing of deeper dermal exogenous pigments. Our preliminary observations also confirmed a significant improvement of tattoo procedure-induced micro-textural changes thanks to a tissue remodeling effect induced by the 1064-nm Q-S fractional laser photo-acoustic ablation.
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