LONG TERM FOLLOW-UP OF PATIENTS HAVING ERBIUM YAG LASER TREATMENT OF PELVIC ORGAN PROLAPSES

Bizjak Ogrinc U1, Sencar S1, Vizintin Z2

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

Abstract 400
ePoster 6
Scientific Open Discussion Session 25
On-Demand
Retrospective Study Pelvic Organ Prolapse New Devices
1. Juna Clinic, 2. Fotona
Presenter
U

Urska Bizjak Ogrinc

Links

Abstract

Hypothesis / aims of study
In this paper we are reporting about assessment of long term effects of non-ablative ErYAG laser therapy used for treatment of pelvic organ prolapses.
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 pelvic organ prolapses (POP) in years 2012 an d 2013 were included. The study was performed by retrospective analysis of data recorded from patient charts. Patients’ demographic was described with age, parous status and BMI at baseline. POP grades were assessed with Baden-Walker scale at the baseline and at all follow-ups. Initial treatment consisted of 2-5 laser sessions with two months interval. Maintenance single session treatments were performed according to the patients’ needs. At each visit photographs of prolapses under straining were obtained and graded by two physicians. Treatment discomfort was measured with 10 grade VAS scale and at every follow-up patients were interviewed about their satisfaction with the therapy. Follow-ups were performed at 2, 6, 12, 24 and 36 months after the first laser session for all patients. Further follow-ups were performed for patients coming to maintenance treatments, prior to the execution of the maintenance session.
Results
67 patients having cystoceles of grades II–IV that have been treated with non-ablative erbium laser in the period of 2012 - 2013 were included in this study. Patient’s average age was 54.9 yrs, parous status 2.2 and BMI of 25.5. The average POP grade before the treatment was 2.36 ±0.62 and was significantly (p<0.001) reduced with laser treatment: after the first session to 1.5 ±0.79, after 6 months to 0.94 ±0.78 and after 12 months to 0.86 ±0.78. Follow-up at 24 months showed slight worsening of POP with average grade 1.13 ±1.02 and at 36 months (after the worsened patients received additional session) follow-up again showed improvement to 0.89 ±0.79. 20 patients continued with periodical maintenance sessions receiving in average 2 (1–4) sessions in an average maintenance period of 4.3 years (3-6). Treatment discomfort was very low (average score of 0.4) and patient satisfaction high (median level of 4 on scale 1-5). There were no adverse effects of this treatment reported.
Interpretation of results
Non-ablative ErYAG laser was first time mentioned as a possible therapy for POP in a paper published in 2012 [1] and we started to treat our patients with this technology by the end of the same year. In the period of 2012-2013 we successfully treated many patients and did a study with one year follow-up [2] showing that this therapy is safe and efficacious. In following years we treated even more patients with good results and without any adverse effects. Although this technology spread and there are already many users performing it all around the world – one survey [3] showed more than 4600 patients safely treated in 72 clinics in 27 countries - there is still no studies to show long term results and safety of many repetitive treatments.
Our study showed that maintenance treatments are very safe and that it is thus possible to do safely many treatments. So, we believe that non-ablative erbium YAG laser therapy for pelvic organ prolapses is viable minimally invasive option for long term reduction of POP symptoms with a possibility to prolong the effects with maintenance treatments done once a year.
Concluding message
Erbium laser treatment for pelvic organ prolapses demonstrated good efficacy in the improvement of cystoceles and minimal patient discomfort during the treatment, with no adverse effects. This study showed that it is safe to use repetitive maintenance sessions of non-ablative ErYAG laser to prolong desired therapeutic outcome up to six 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 : Non-ablative vaginal erbium YAG laser for the treatment of cystocele, Italian Jorunal of Gynecology and Obstetrics, 29:N1 (2017)
  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
18/04/2024 18:15:19