Transcript Diapozitiv 1

Adolf Lukanović, M.D., Ph.D.
Mija Blaganje, M.D.,
Department of Gynecology and Obstetrics
University Medical Centre, Ljubljana, Slovenia
VI hrvatsko-slovenski simpozij o menopauzi i andropauzi,
Hotel Neptun, Brijuni, 10.09.2011
Stress Urinary Incontinence Is the Most Common
Type in Women Based on Literature Review
Mixed
Urge
Stress
Hampel C, et al. Urology. 1997;50(suppl 6A):4-14.
Urinary incontinence affect
at least one in every 4 women
LITERATURE
REVIEWS
LARGE-SCALE
SURVEYS
Minassian VA, et al. Int J Gynecol Obstet 2003;82:327-38; Hunskaar S, et al. BJU Int 2004;93:324-30;
Kinchen KS, et al. J Womens Health 2003;12:687-98; Hannestad YS, et al. J Clin Epidemiol 2000;53:1150-7
Urinary incontinence is prevalent, bothersome …but
underreported: only 31 - 45% seek help
Overall rate 31%
Hunskaar S, et al. BJU Int 2004;93:324-30; O’Donnell M, et al. Eur Urol 2005;47:385-92;
Diokno AC, et al. Am J Manag Care 2004;10:69-78; Diokno AC, et al. J Urol 2003;170:507-11
Prevalence of urinary incontinence
increases with age
Hannestad YS, et al. J Clin Epidemiol 2000;53:1150-7; Hunskaar S, et al. BJU Int 2004;93:324-30
Next 20 years
18% increase of women > 75 years
38% increase of women > 80 years
Urinary incontinence:
11.6% > 65 years
8.5 % < 65 years
AGE RELATED CHANGES OF PELVIC FLOOR MUSCLE
Koelbl et al 1987 Obstet Gynecol
BULKING EFFECT
Before application
6 o’clock
after application
3 o’clock
9 o’clock
THE IDEAL BULKING AGENT PROPERTIES:
 Non-immunogenic
 Non long term side effect
 Permanent
 High safety profile
 Non-migratory
 Non-erosive
 Non-inflammatory
 Easily stored
 Easily injected
 Painless
BULKING AGENTS
 Teflon (Berg 1973, Politano 1974)
 Purified bovine collagen (Contigen) (Shortliffe 1989)
 Autologuos fatty tissue (Gonzales de Gariby 1989)
 Silicon mikroimplants (Macroplastique) (Buckley 1992)
 Mikrobaloons (Pycha 1998)
 Copolymer of non-animal stabilised hyaluronic acid and dextranomer microspheres
(Zuidex/Deflux) (Sternberg 1999)
 Autologuos chondrocites (Bent 2000)
 Pyrolitic carbon coated beads (Durasphere) (Calvosa 2000)
 Acellular porcine collagen (Permacol) (Lightfoot 2001)
 Polyacrylamid gel (97,5% water+2,5% cross-linked polyacrylamide)
Bulkamid (Chancellor 2001)
 Adjustable balloons (ACT) (Sauter 2002)
SYNTHETIC BULKING AGENTS IN URETHRAL TISSUE
Urethral sphincter muscle
augmented with Contura’s
hydrogel (violet).
Picture taken 3½ months after
injection.
Scattered macrophages appear
in the gel, no surrounding
foreign-body reaction - no
fibrosis.
SYNTHETIC BULKING AGENTS IN URETHRAL TISSUE
Bladder augmented with
Bulkamid hydrogel (violet).
Picture taken 14 months after
injection.
Gel appears as an irregular mass
containing scattered
macropgages which formed
minute islands or a fine network
within a homogeneous gel
The Bulkamid® Kit
1 optic 0˚
Light cable
(not included in
the kit)
1 irrigation set
2 needles 23 G
2 prefilled 1 cc. Bulkamid® syringes
Bulkamid ® Cystoscope
DURASPHERE
Migration after 6 months
250-300 um
Pannek , J Urol 2001:166,1350
Lecce 2005
CULTIVATION AND CHARACTERISATION OF
MYOBLASTS
Single myoblasts were
manually collected with a
micropipette, then clones
of pure myoblasts with
100% of desmin positive
muscle cells could be
cultured.
MUSCLE BIOPSY
ULTRASOUND GUIDED INJECTION
Skeletal muscle portion was obtained from a small open cut biopsy
of the non–dominant biceps muscle
Myoblast isolation and expansion was performed in GMP cerified cell-processing
laboratory Innovacell Biotechnologie AG, Innsbruck, Austria
Autologus myoblast suspension was injected under transurethral ultrasound device
THE IMPACT OF LOCALLY INJECTED STEM CELLS FOR THE
TREATMENT OF FEMALE STRESS URINARY INCONTINENCE
PROSPECTIVE RESEARCH TRIAL DEPARTEMENT OF GYNECOLOGY UCC LJUBLJANA
INCLUSION CRITERIA
 Urodinamic proven pure SUI
(standard ICS protocol)
 Age 50-70
 Normal US examination
 Normal status gyn.
 38 patients
EXCLUSION CRITERIA
 Urge incontinence
 Descensus or prolaps
 Any sign of inflamation
 Serious sistemic diseases
 Previous antiincontinence
surgery
 UIS- amount of leaked urine measured semiquantitative
 UIE- UI episodes count from a 3 day voiding diary
 QOL- quality of life questionnaire
 VAS- visual analog scale of the degree of suffering
 PGI-I – modified patient global impression scale
Characteristics of patients treated with autologous myoblasts at baseline, at
completion of preoperative ES cycle and at 6 weeks postoperatively
(Myoblasts + ES)
Preoperative
Postoperative
p
Baseline
ES
Myoblasts + ES
38
38
37
UIE
13 (4-41)
12 (1-35)
5 (0-33)
<0.0001
UIS
24 (4-67)
18.5 (2-49)
5 (0-33)
<0.0001
Stress test negative
0
1
29
<0.0001
PGI-I cured
improved
unchanged
0
0
38
0
7
31
5
29
3
<0.0001
56.5 (28-92)
63 (29-99)
78 (41-105)
<0.0001
8 (3-10)
7 (4-10)
3 (0-9)
<0.0001
No. of patients
I-QOL
VAS
The numeric variables are presented as median values (range). P values are for ES vs. Myoblasts + ES
IMPROVEMENT FROM BASELINE
VAS
QOL
Myoblast+ES
UIE
ES
UIS
0%
20%
40%
60%
VAS- visual analog scale of the degree of suffering
QOL- quality of life questionnaire
UIE- 3-day bladder diaries for urinary incontinence episodes
UIS- amount of leaked urine measured semiquantitative
80%
 The use of embrionic stem cells is limited due
to unresolved medicolegal questions
 When using stem cells of adult human being
there are no medicolegal dilemas
 TO WHAT EXTEND THE MYOBLASTS SHOULD PROLIFERATE ?
 HOW TO PREVENT URETHRA OBSTRUCTION ?
 WHAT WILL BE THE EFFECT OF URETHRAL HIPERMOBILITY ON THE SUCCESS
OF STEM CELL THERAPY ?
 DANGER OF MALIGNANT ALTERATION
 ETHICAL ASPETSC AS THIS IS EXPERIMENTAL SURGERY
 MEDICOLEGAL ASPECTS IN CASE OF FAILURE
 COSTS
 LEARNING CURVE FOR APLICATION
 WILL STEM CELLS PRODUCE BETTER RESULTS THAT
CURRENTLY AVAILABLE MEDICAL OR SURGICAL THERAPY?
 WHAT MORBIDITY WILL IT CAUSE ?
STEM CELL THERAPY IS PROMISING.
BUT BEFORE ADOPTING IT LET’S BE SURE IT WORKS WHEN
COMPARED TO CURRENTLY AVAILABLE PROCEDURES AND
THAT IT WON’T HARM OUR PATIENTS.
WE ARE THE ONLY ONES WHO CAN PROTECT OUR PATIENTS
DON OSTERGARD, IUGA ANNUAL MEETING CANCUN 2007
TAKE HOME MESSAGE
URINARY INCONTINENCE
should not be viewed as a normal part of aging
it should be viewed as treatable
Thank you for the attention