NON-ABLATIVE ERBIUM LASER TREATMENT OF STRESS AND MIXED URINARY INCONTINENCE – SEVEN YEARS FOLLOW-UP

Sencar S1, Bizjak Ogrinc U1, Vizintin Z2

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 318
ePoster 5
Scientific Open Discussion Session 21
On-Demand
Stress Urinary Incontinence Mixed Urinary Incontinence New Devices
1. Juna Clinic, 2. Fotona
Presenter
S

Sabina Sencar

Links

Abstract

Hypothesis / aims of study
The purpose of this clinical study was to evaluate long term effects of non-ablative ErYAG laser therapy used for treatment of female stress and mixed urinary incontinence.
Study design, materials and methods
This is a retrospective, single center pilot study, in which female patients who received non-ablative ErYAG laser treatment for stress and mixed urinary incontinence (SUI, MUI) in years 2012 and 2013 and had 5 and 7 years follow-ups were included. The study was performed by retrospective analysis of data recorded from patient charts. Patients’ demographic was described with age, parous status and incontinence type (SUI; MUI) at baseline. Severity of urinary incontinence was assessed with ICIQ-UI SF questionnaire at the baseline and at all follow-ups. Scores of ICIQ-UI SF questionnaire were grouped into categories: mild, moderate, severe and very severe according to Klovning division (0 = no UI, 1-5 = mild UI, 6-12 = moderate UI, 13-18 = severe UI and 19-21 = very severe UI).  Initial treatment consisted of two laser sessions with two months interval. The patients were followed at 2, 6 and 12 months and after that the follow-ups were performed for patients coming to either regular annual check-ups or to maintenance treatments. The last two follow-ups were scheduled for 5 and 7 years after the laser treatment.
Results
37 patients having stress or mixed urinary incontinence that have been treated with non-ablative erbium laser therapy in the period of 2012 - 2013 and had 5 and 7 years follow-ups were included in this study. Patient’s average age was 49.6 years (range 22 -68) and parous status 1.9 (range 0-3). Twenty-five (67.6%) patients had at the baseline SUI and twelve (32.4%) had MUI.  The average ICIQ-UI SF score before the treatment was 5.2 (range 1-10) and there were 21 (56.8%) patients in mild UI group and 16 (43.2%) in moderate UI group. All patients significantly (p<0.001) improved their urinary incontinence: after two sessions and 12 months the average score was 0.5 (range 0–4). 75.7% of patients become dry and the remaining 24.3% of patients had mild UI. All of these patients were very satisfied with the treatment and results and didn’t have any adverse effects. Also all patients continued with periodical (annual) check-ups and when felt necessary received additional sessions with the aim to retain their improved incontinence situation. During the period of 7 years these patients received 42 additional treatment sessions. The largest number of sessions (4) received only one patient, 4 patients (10.8%) received three maintenance sessions, 9 patients (24.3%) received two sessions, 8 patients (21.6%) received one additional session while 15 patients (40.5%) didn’t have any additional sessions in 7 years from their initial laser therapy. At 5 years follow-up 12 patients (32.4%) had mild urinary incontinence while 25 patients (67.6%) were dry, and at 7 years follow-up 14 patients (37.8%) had mild UI while 23 patients (62.2%) were dry.
Interpretation of results
We learned about non-ablative ErYAG laser therapy for female urinary incontinence in 2012 [1] and started to treat our patients with this technology during the same year. In the period of 2012-2013 we performed a study with 175 patients suffering from SUI and MUI with one year follow-up [2] showing that this therapy is safe and efficacious. In following years we treated several hundred patients with good results and without any adverse effects. During the period of last eight years (since our beginning with this therapy) the technology of non-ablative ErYAG laser for female urinary incontinence spread and there are already many users performing it all around the world – one survey [3] showed more than 19,000 patients safely treated in more than 100 clinics in 35 countries. However, there is still no studies to show long term results and safety of many repetitive treatments.
Our study showed that the effects are lasting longer than we expected as well as that maintenance treatments are very safe and that it is thus possible to continue treating patients with additional sessions for a long period of time. Our already long experience with non-ablative erbium YAG laser therapy for stress and mixed urinary incontinence is giving us confidence to consider this laser treatment as the treatment of choice in cases of mild to moderate SUI and MUI.
Concluding message
Non-ablative Erbium laser treatment for mild to moderate stress and mixed urinary incontinence showed good efficacy in the improvement of female urinary incontinence and minimal patient discomfort during the treatment, with no adverse effects. This study showed that the duration of the effect is relatively long and that it is safe to use repetitive maintenance sessions of non-ablative ErYAG laser to prolong desired therapeutic outcome up to seven years after the beginning of the therapy.
References
  1. Vizintin Z, Rivera M, Fistonic I, Saraçoglu F, Guimares P, Gaviria J, Garcia V, Lukac M, Perhavec T, Marini L. Novel minimally invasive VSP Er:YAG laser treatments in Gynecology, J Laser and Health Academy, No.1. (2012)
  2. Bizjak Ogrinc U, Sencar S, Lenasi H. Novel Minimally Invasive Laser Treatment of Urinary Incontinence in Women, Laser in Surgery and Medicine 47:689–697 (2015)
  3. Gambacciani M, Cervigni M, Gaspar A, Gaviria J, Novakov Mikic A, Koron N, Vizintin Z. Safety of non-ablative erbium laser for women’s health: a review of 113.000 patients treated in last eight years. Submitted as an abstract to 50th ICS Annual Conference 2020
Disclosures
Funding None Clinical Trial Yes Public Registry No RCT No Subjects Human Ethics not Req'd This is a retrospective study analyzing long term effects on the same patients which were included in a clinical study with Ethical committee approval in which just 12 month follow-up was observed. Helsinki Yes Informed Consent Yes
06/05/2024 00:22:49