Biopolymer GmbH & Co.KG - Germany
Urinary Incontinence
Biopolymer GmbH & Co.KG - Germany
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.
Biopolymer GmbH & Co.KG - Germany
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.
Biopolymer GmbH & Co.KG - Germany
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.
Biopolymer GmbH & Co.KG - Germany
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.
Biopolymer GmbH & Co.KG - Germany
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.
Biopolymer GmbH & Co.KG - Germany
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-SephadexDextran positively
Charged Dextranomere.
Urodex composition:
Sodium Hyaluronate cross linked:
17mg
DEAE Sephadex Dextran + chagre: 50mg
Sodium Chloride:
6.9mg
Water for injection:
1.0ml
Biopolymer GmbH & Co.KG - Germany
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 ( DiethylaminoethylDextran) , 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 ).
Biopolymer GmbH & Co.KG - Germany
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.
Biopolymer GmbH & Co.KG - Germany
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.
Biopolymer GmbH & Co.KG - Germany
Urodex Kit:
Urodex Kit:
4 syringes – 1.0ml
2 sterile needles 20G
1 Applicator
1 catheter
Biopolymer GmbH & Co.KG - Germany
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.
Biopolymer GmbH & Co.KG - Germany
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.
Biopolymer GmbH & Co.KG - Germany
URODEX Injection
 Introduce mounted
needle in the
applicator
 Important! Opening
of the needle in
direction upward
Biopolymer GmbH & Co.KG - Germany
The Implantation
 1 syringe/1 ml in
position 3
Biopolymer GmbH & Co.KG - Germany
The Implantation
 1 syringe/1 ml in
position 9
Biopolymer GmbH & Co.KG - Germany
The Implantation
 1 syringe/1 ml in
position 12
Biopolymer GmbH & Co.KG - Germany
The Implantation
 1 syringe/1 ml in
position 6
Biopolymer GmbH & Co.KG - Germany
Clinical trials
Biopolymer GmbH & Co.KG - Germany
Thank you