Embracing New Technologies: Vaginal Laser Therapy. Dean Elterman, MD, MSc, FRCSC Urologic Surgeon University of Toronto

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1 Embracing New Technologies: Vaginal Laser Therapy Dean Elterman, MD, MSc, FRCSC Urologic Surgeon University of Toronto

2 Faculty/presenter disclosure Faculty: Dean Elterman, MD MSc FRCSC Relationships with commercial interests: Grants/Research Support: Boston Scientific, Pfizer, Clarion Speakers Bureau/Honoraria: Allergan, Astellas, Coloplast, Boston Sci.,Ferring, Pfizer, Medtronic, Clarion, Consulting Fees: Medtronic, BSCI, Coloplast

3 Outline Review Stress Urinary Incontinence Pelvic Floor Muscle Training Devices Vaginal Laser Therapy

4 Diagnostic Evaluation of Female Stress Incontinence History Physical Examination Urinalysis Voiding Diary Pad Test Uroflowmetry Residual Urine Measurement Urodynamics Cystoscopy

5 Integral Theory Pelvic organ prolapse and abnormal pelvic symptoms are mainly caused by connective tissue laxity in the vagina or its supporting ligaments

6 Hammock Theory Continence is result of good suburethral support; Hammock of support created by endopelvic fascia and anterior vaginal wall by connections to arcus tendineus and levator ani muscles

7 Risk Factors Multiparity Vaginal delivery (OR 2.4) Hysterectomy (OR 1.6) Obesity (OR of 1.06 per unit of BMI) Caucasian race (OR 2.84 compared to African American)

8 Gential Syndrome of Menopause and Urethral Atrophy atrophy of the sphincteric component (mucosa & submucosa vascular plexus), there is a 30% loss of effectiveness of the mechanism of closure. Diminishment of the sensitivity of urethral muscles to adrenergic stimulation, with less effectiveness of contraction of the rabdosphincter Schrerter et al, 1976; Geelen 1988, Brincat et al, 1985; Thomas et al, 1980; Yarnell et al, 1981.

9 Mid-Urethral Sling (TOT) ISSUES: RECOVERY, COMPLICATIONS

10 PELVIC FLOOR MUSCLE TRAINING (PELVIC PHYSIOTHERAPY)

11 Pelvic Floor Muscle Training Is the first-line treatment for stress and mixed urinary incontinence in women (Grade A, Level 1 evidence) (Wilson, 2005) PFMT is effective & cost-effective in reducing prolapse symptoms & should be recommended as first-line management for prolapse (Hagen, 2011) Consists of active pelvic floor muscle exercises with or without the addition of biofeedback, Estim and/or intravaginal resistance (Wilson, 2005)

12 British Guidelines As presented at the ICS Conference 2010 in Toronto: In Britain, pelvic floor muscle training should be the first line of defense against SUI Should be completed before surgical intervention is considered

13 DEVICES

14 Continence Pessary - Uresta

15 Poise Impressa Bladder Supports

16 LASER VAGINAL THERAPY

17 Background to Vaginal Lasers Stress urinary incontinence (SUI) the involuntary loss of urine during coughing sneezing, and physical exertion Affects up to 14-28% younger women, up to 35% of older women (>60) 15-18% comorbidity rates with pelvic organ prolapse Proposed causes: Relaxation of periurethral tissue and impairment of urethral sphincter Damage to pelvic floor neuromusculature (i.e., childbirth) (Abrams et al., 2003; Bai et al., 2002; Bump et al., 1998; Dietz & Clark, 2001; Luber, 2004; Rovner & Wein, 2004)

18 Background to Vaginal Lasers Women with SUI also shown to have reduced collagen production Weakens support of bladder neck Insufficient support of the urogenital tract Effect of thermal lasers Non-ablatively heat targeted collagen tissue Enhance collagen structure (tightness, elasticity) Stimulates neocollagenesis Much research in dermatology and aesthetic medicine (Bordendorf et al., 2010; Wang et al., 2010; Wong et al., 2008; Wood et al., 2010)

19 Erbuim:YAG laser Er YAG Smooth Pulse Laser (Fontona) Non-ablative, non-invasive Laser energy transmitted as heat onto mucosa surface, then dissipated into deeper tissue layers MonaLisa Touch CO2 laser is available to treat GSM (atrophy, dyspareunia) but is not approved to treat SUI

20 Laser Mechanism Of Action Er:YAG non-ablative Smooth Mode thermal effects in the vaginal tissue are: stimulating collagen remodeling synthesis of new collagen fibers The final result of collagen-neogenesis and remodeling is tightening of the part or the whole vaginal canal

21 Fractional CO2 CO2 Laser (10,600nm wavelength) Delivered through a hand piece dispersing laser energy onto the tissue in the vaginal canal Mucosa is penetrated and an open wound is produced to evoke a response Similar to punching holes in a golf green for aeration

22 Fractional CO2

23 ErYAG vs CO 2 Comparison Dr. Gaspar in press

24 ErYAG vs CO 2 Comparison Dr. Gaspar in press

25 Equipment PS03 and R11 for Gynecology G-Set

26 Equipment G-Runner G-Runner is a robotic, digitally controlled scanning handpiece

27 Part of IncontiLase protocol, full spot irradiation of the whole vaginal wall using angular adapter

28 Part of IncontiLase protocol, fractional irradiation of the anterior vaginal wall using angular adpter

29 R09-2Gu New handpiece for Intra-Urethral treatments

30 Non-Ablative Lasers Using the proper dosage the temperature in mucosa reaches 60 C to 63 C This is the optimal temperature for the process of shortening the collagen fibers and neocollagenesis [1] 1) Dams SD, de Liefde-van Beest M, Nuijs AM, Oomens CW, Baaijens FP : Pulsed heat shocks enhance procollagen type I and procollagen type III expression in human dermal fibroblasts, Skin Res Technol Aug;16(3):354-64

31 Non-Ablative vs. Ablative Lasers Smooth ErYAG is very safe for vaginal treatment

32 Mechanism of Action Before Laser Irradiation After Vaginal wall structure Photo-thermal effect Thermal shrinkage of top layers and mechanical pull of deeper structures Shrinked and thicker wall after neo-collagenesis Courtesy of Juna Clinic M. Rivera measured an average shrinking of vaginal canal of 12 mm (or 17%) A.A. Bezmenko measured an average thickening of vaginal wall of 1.5 mm (or 56%) Courtesy of Juna Clinic

33 Adverse Effects of Lasers Adverse effect Frequency* Comment Edema 100,0% transient, max. 48 hours Pain (during the treatment) 14,7% without anesthesia, max. grade 3 on the scale to 10 Pain(post-op) 4,3% transient, max. 1 week Superficial burns 1,6% fully resolved in 7-10 days Bleeding 3,7% pin-point bleeding, very quickly healed Stronger vaginal discharge 5,4% transient, max. to 4 days De-novo urge urinary incontinence 3,2% transient, max. up to 3 weeks * based on collected information from 6 medical sites where a total of 764 patients were treated with IncontiLase

34 Laser Vaginal Therapies - Advantages Minimally invasive (no cutting, no bleeding, no ablation) Ambulatory procedure Virtually painless, no anesthesia needed No special pre or post-op preparation No consumables Quick and easy procedure High success rate in cases of mild and moderate SUI

35 Radiofrequency (RFA) (ThermiVa) Cochrane Database Systematic Review Unknown whether transurethral radiofrequency collagen denaturation, as compared with sham treatment, improves patient-reported symptoms of urinary incontinence Evidence is insufficient to show whether the procedure improves disease-specific quality of life. Evidence is also insufficient to show whether the procedure causes serious adverse events or other adverse events in comparison with sham treatment no evidence was found for comparison with any other method of treatment for UI

36 LASER TREATMENTS Stress Incontinence

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38 Basic Science SUI and VLRx SUI patients BEFORE erbium laser: Degeneration, atrophic changes in stratified squamous epithelium Disorganization fibrillar structures intercellular matrix Microcirculatory disorders Lapii, G.A., Yakovleva, A.Y. & Neimark, A.I. Bull Exp Biol Med (2017) 162: 510

39 Basic Science SUI and VLRx SUI patients AFTER erbium laser: Neocollagenasis, elastogenesis Reduction epithelial degeneration/atrophy Increased fibroblasts and neoangiogenesis Increased density of capillaries Lapii, G.A., Yakovleva, A.Y. & Neimark, A.I. Bull Exp Biol Med (2017) 162: 510

40 Incontilase Previous Studies Fistonic et al., 2015 N = 92 Treatment 1 treatment, followups Control group = Kegal exercise group, followups Reduction in Incontinence Improved Vaginal Pressure Climacteric. 2015;18 Suppl 1:37-42.

41 Incontilase Previous Studies 175 patients with UI 1 year follow up Treatment group: 2.5 +/- 0.5 Incontilase treatments Control group: none No adverse effects 60% dry at 6M 62% dry at 12M Ogrinc et al. Lasers Surg Med Nov;47(9):689-97

42 Tien, YW. et al. Int Urogynecol J (2017) 28: 469 Effects of laser procedure for female urodynamic stress incontinence on pad weight, urodynamics, and sexual function 79% 78%

43 Cystocele: Results Results: Individual patients cystocele improvement (reduction) cystocele grade reduction 0 1 3,57% ,43% ,86% ,14%

44 PROLAPSE Treatment With Vaginal Laser Courtesy of Juna Clinic Under Pressure: Before Under Pressure : 3M After Tx2

45 Patient No.27 Courtesy of Juna Clinic Under Pressure: Before Under Pressure : 2.5M After Tx1

46 Key Benefits Of Er:YAG Vs. Estriol HormonalTherapy(HRT)doesn t increase collagen or vascularization, it only increases the glycogen level in the vaginal epithelium and its turn over There is a high rate of patient discontinuationof HRT HRT creates in some patients breast pain and irregular uterine bleeding. Laser increases the epithelial thickness as well as vascularization of the lamina propria. Not all patients wish to receive HRT and have valid concerns to it s long term use.

47 GSM/Atrophic Vaginitis Erbium YAG Before Changes in Epithelial Tissue Parakeratosis (keratinocyte growth) Acanthosis Increase of Glucogenic Store After Changes in the Lamina Propia ( Connective Tissue) Marked Angiogenesis. Major Congestion (red blood cells in the lumen of neovessels) Collagenesis Increase in the Cellularity of the Extracellular Matrix

48 Histological study of vaginal walls biopsy Patient N., aged 56, a/c 38/15, BEFORE (a) and AFTER (b) treatment а b Reactive epithelial changes Vascular buds" (hematoxylin/eosin, magnification 40 10)

49 Vaginal Erbium Laser for GSM in Cancer Survivors Bojanini J.F, Mejia A. Laser treatment of vaginal atrophy in post menopause and post gyn cancer

50 Vaginal Laser Rejuvenation (VLR) Tight and expanded / relaxed vaginal canal (Vaginal Relaxation Syndrome)

51 Measurement tools IntimaLase TM Objective tools: MRI Before 1 Month After 69,17mm 56,64mm Courtesy of Dr. Gaspar

52 Take Home Messages Step-wise approach least invasive Weight loss, smoking cessation, fluids Pelvic floor physio is highly effective Kegel s alone are not sufficient Biofeedback can augment PPT Vaginal laser treatments provide alternative to surgery, providing safe and effective treatment in short term Non-Ablative lasers show 78% improvement or cure at 1 year

53 THANK YOU UNC! Dean Elterman, MD, MSc, FRCSC