Urinary Incontinence. Biopolymer GmbH & Co.KG - Germany

Transcription

1 Urinary Incontinence

2 Treatment Options: 1. Physical Therapy: a conservative early stage treatment for UI, including pelvic floor muscles training known as Kegel exercise. 2. Medications: by means of pharmaceutical drugs ( fesoterodine, tolterodine, oxybutynin,..etc ). 3. devices: absorbent pads, urinary catheters. 4. Surgical procedures. 5. Bulking agents Urethral Injections of impant material.

3 Treatment Options: Surgical procedures: 1. TVT: Tension-Free transvaginal sling. 2. TOT: Transoburator tape sling. 3. Mini Sling ( mini-arc ) ( TVT-secure) 4. Marshal-Marchetti-Krantz: retropubic suspension / bladder neck suspension 5. Artificial unrinary sphincter.

4 Treatment Options: Urethral Injections Bulking Agents: Is a minimal surgical procedure providing An alternative in treatment options: The Ideal Bulking agent of choice must include following charecteristics: 1. Biocompatible. 2. Biodegradable. 3. Bio-stable: no deformation after injection. 4. No Migration after implantion. 5. No erosion after implantion. 6. Easy to applicate without the need to apply pressure when injecting.

5 Treatment Options: Available Bulking Agents for UI: 1. Polytetrafluoroethylene(teflon) : no longer used. 2. Autologous fat: no longer used. 3. Macroplastique: silicone elastomer polydimethylsiloxane suspended in polyvinylpyrrolidone PVP Carrier. It is a permanent implant applied by transurethral technique injection beneath the lining of urethra can cause urethral erosion with irreversable damage in case of failure of procedure procedure must be done in operation room. 4. Contigen: Glutar aldehyde cross linked bovine collagen: it begins degradation within 12 weeks with complete degaradation within 19month, and patient must undergo a skin test to exclude hypersinsensitivity due to collagen ( animal origin ) before one month of the procedure.

6 Treatment Options: Available Bulking Agents: 5. Bulkamid: 25% polyacrylamide hydrogel, 97% apyrogenic water, is a permanent implant (nonbiodegradable) 6. Durasphere: carbon coated zirconium oxide particles suspended in water soluble B-glucan vehicle, is a permanent implant, upon clinical trials Durasphere migrates from impantation site which might cause permanent urinary retention. 7. Coaptite: calcium hydroxylapatite particles suspended in sodium carboxymethylcellulose, water, glycerin gel form carrier, upon clinical trials the particles becomes deformed, irregular along with migration from injection site resulting in periurethral fibrosis, obstruction, prolapse.

7 Treatment Options: Available Bulking Agents: 8. Tegress: formrly known as URYX : ethylenevinyl alcohol copolymer suspended in dimethyl sulfoxide: have discontinued sales due to reports of 37% erosion rates. 9. Zuidex: Dextranomere microspheres in cross linked hyaluronic acid carrier. 10.Urodex : DEAE-Sephadex- Dextran positively Charged Dextranomere. Urodex composition: Sodium Hyaluronate cross linked: 17mg DEAE Sephadex Dextran + chagre: 50mg Sodium Chloride: 6.9mg Water for injection: 1.0ml

8 Urodex designed Technolgy: Why to use Urodex? What is the added Benefits of Urodex? In order to realize the added benefits of Urodex, a summary explaining the designation technology of the product will answer many questions that may arise. 1. In SUI and as the condition is resulting from pelvic floor muscles weakness that leads to insufficient closure of urethra, basically a material that acts as a bulking agent is needed in order to act in increased tissue thickness at injection site that will aid in complete closure when muscles plays its normal role. and accordingly, the material of choice was DEAE-DEXTRAN ( Diethylaminoethyl- Dextran), the choice was based upon that Dextran is a Biocompatible, Biodegradable, non-immunogenic molecule. Dextran: consists of linked glucan with side chains attached to the 3-position of the backbone glucose units, and it is produced by bacterial fermentation process ( nonanimal origin ).

9 Urodex designed Technolgy: 2. DEAE-Dextran Biomaterial cannot be introduced by injection And as the concept of the products is based upon minimal Surgical procedure a carrier material is needed to carry the DEAE-DEXTRAN to site of implantation, the choice of carrier material was the specially designed cross linked hyaluronic acid Technically adjusted to play the role of a ( carrier ), again the choice was upon that HA is a biocompatible, biodegradable, Non-immunogenic molecule. 3. After that and as a long duration effect is favorable in treatment of SUI the Specially designed cross linking process was applied to DEAE-DEXTRAN to obtain a cross Linked DEAE-DEXTRANOMERE or what is called a DEAE-Sephadex-Dextran, Sephadex Is a trade mark for cross linked dextran, where cross linking process results in a long term Duration of the implant to be degraded gradually.

10 Urodex designed Technolgy: 4. Finally, a ( fine tuning ) process was created by Biopolymer GmbH Germany to ensure maximum effect results outcome for the product ( Urodex ) to be unique and distinguished in SUI Treatment options, the ( fine tuning ) was made by creating a positive charge on DEAE-Sephadex Dextran which stimulates collagen formation in site of implantation and leading by that for optimum results in treatment of SUI by stimulating tissue regeneration process. Accordingly, DEAE-Sephadex-Dextran is a polycationic cross linked dextran with tissue regeneration stimulating effect. 5. Accordingly, the benefits of Urodex are summarized as following: A. Biocompatible: as the used materials is a natural component of human body tissues, it is non-immunogenic ( non-animal origin ), and biocompatibility is optimal due to formation of fibroblast and collagen fibers that surrounds the microparticles. B. Biodegradable: the used materials are completely degradable with safe clinical profile. C. Long action duration: due to cross linking process that extends up to 5 five years. D. No Migration from implant site: due to positively charged microparticles the positive charge plays a role in ( ancoring ) the implant through inter-cellular interactions leading to fibroblasts and collagen fibers surrounding the implant material as well that microparticles size used ensures no migration. ( safe particel size 80 micron ). E. Stimulation of collagen formation: due to positive charges.

11 Urodex Kit: Urodex Kit: 4 syringes 1.0ml 2 sterile needles 20G 1 Applicator 1 catheter

12 Urodex Applicator Special design for minimal invasive and safe implantation Controlled implantation in a 4-position (3, 6, 9, 12) symmetrical placement with injection volume of 1.0ml per position. Periurethral Injection technique.

13 Urodex Applicator Designed with measurements for implantation in precise site. After measurement of urethra by catheter, transfer the length to the applicator, insert the applicator into urethra to the previosuly marked measurement and inject the implant material. Video is available for procedure.

14 URODEX Injection Introduce mounted needle in the applicator Important! Opening of the needle in direction upward

15 The Implantation 1 syringe/1 ml in position 3

16 The Implantation 1 syringe/1 ml in position 9

17 The Implantation 1 syringe/1 ml in position 12

18 The Implantation 1 syringe/1 ml in position 6

19 Clinical trials

20 Thank you