Long term effects of non ablative erbium laser treatment of female stress urinary incontinence

Novakov Mikic A1, Lepes Bingold B1, Vizintin Z2

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 126
E-Poster 1
Scientific Open Discussion ePoster Session 7
Wednesday 4th September 2019
13:10 - 13:15 (ePoster Station 6)
Exhibition Hall
Stress Urinary Incontinence Prospective Study Female
1.Poliklinika “Novakov et al.”, 2.Fotona
Presenter
A

Aleksandra Novakov Mikic

Links

Poster

Abstract

Hypothesis / aims of study
Stress urinary incontinence (SUI) is a common cause of urinary incontinence and is affecting large number of women influencing significantly their quality of life. There is a large range of therapies for SUI from lifestyle/behavioral modification to surgical interventions, and these therapies differ in terms of both effectiveness and risk. However, current treatment options raised some concerns regarding safety and efficacy and there was a quest for new treatment options. Several years ago vaginal laser therapy was offered as a minimally invasive treatment option for SUI.
The purpose of this study was to evaluate long term efficacy and safety of non-ablative erbium YAG laser treatment for female stress urinary incontinence (SUI).
Study design, materials and methods
In this single center prospective study in the period from April 2014 to January 2016 we performed ErYAG laser thermo-therapy on a number of female patients having SUI. International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form (ICIQ-UI-SF) as well as Incontinence Severity Index (ISI) defined according to Klovning proposal were used for assessment of SUI. Patients received two laser sessions with 4-6 weeks interval. Patients’ satisfaction was measured with 11 point numerical scale. Follow-ups were performed at 1, 3, 12 and 18 months. Long term follow-ups were performed via telephone interviews during which aside of ICIQ-UI-SF an additional patients’ satisfaction questionnaire was used to assess the duration of SUI improvement and patients’ readiness to repeat the treatment. Adverse events were observed and registered at every follow-up.
Results
132 patients with SUI were included in this study. Average age was 50.3 yrs (range 23-75) and parity 1.9 (range 0-4). Average score on ICIQ-UI before the treatment was 11.8 and at the 3 months FU 3.7, (improvement of 8.1 point). At 3 months FU 39.2% of patients were dry and 96.9% of patients improved their ICIQ score. All reported adverse effects were mild and transient. 75% of patients have the full effect lasting at least 12 months and 24% at least 18 months. Average duration of full effect was 13.0 months. 85% of patients were not disappointed when the symptoms started to come back. The return of symptoms was gradual and 87% of patients felt no need to repeat procedure for at least 12 months after treatment and 43% of patients declared that they felt no need to repeat the procedure even at 18 months after the treatment. Patients’ satisfaction at 18 months post treatment was very high - 97% of patients were satisfied with treatment. Average satisfaction score at 18 months was 7.9/10; 68% of patients gave grades from 8/10 to10/10; satisfaction of 41% of patients was graded 10/10. 98% of patients would repeat the therapy.
Interpretation of results
The first paper about the use of non-ablative erbium YAG laser for female stress urinary incontinence was published in 2012 [1] and since then there were many clinical studies published confirming the efficacy and safety of this novel therapy. Most of these studies had the follow-ups of 3 to 12 months and just recently one study showed the results up to 24 months [2]. Our results are comparable in efficacy and safety with other studies as well as regarding the longevity of the results with the said 24 months study.
Considering the mechanism of action of this therapy, which is the fixing of hypermobile urethra by collagen remodeling (shrinking) and neo-collagenesis caused by controlled exposure of the tissue collagen to the heat, it is expected to have some collagen degradation through the time and the big question was how long the effects will last, i.e. when the maintenance treatment will be necessary. Our results showed that for majority of the patients (75%) the full effects are lasting at least 12 months, but that for patients with better collagen remodeling capacity the effects could last 18 months and more [2]. 43% of our patients haven’t felt the need to repeat the treatment at 18 months. Our study also showed that large majority of patients (98%) are willing to come back and do the maintenance treatment as well as that the therapy is very safe and that it is thus possible to do safely many treatments. So, we believe that non-ablative erbium YAG laser therapy for female stress urinary incontinence is viable minimally invasive option for long term reduction of SUI symptoms with a possibility to prolong the effects with maintenance treatments done once a year. We already introduced such a regime to number of our patients and we hope to be able to show soon the results after five years of such maintenance regimen.
Concluding message
Erbium laser treatment showed long term efficacy in improvement of female SUI with no major adverse effects noted. Patients’ discomfort during the treatment was minimal and satisfaction very high.
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. Gambacciani M, Levancini M, Russo E, Vacca L, Simoncini T and Cervigni M, Long-term effects of vaginal erbium laser in the treatment of genitourinary syndrome of menopause, Climacteric, 2018 Apr;21(2):148-152. doi: 10.1080/13697137.2018.1436538. Epub 2018 Feb 13
Disclosures
Funding There were no funding or grants for this study Clinical Trial Yes Public Registry No RCT No Subjects Human Ethics not Req'd This treatment protocol was already clinically validated and obtained CE certification quite some time ago Helsinki Yes Informed Consent Yes