Adolf Lukanović, M.D., Ph.D.Mija Blaganje, M.D.,
Department of Gynecology and ObstetricsUniversity Medical Centre, Ljubljana, Slovenia
VI hrvatsko-slovenski simpozij o menopauzi i andropauzi, VI hrvatsko-slovenski simpozij o menopauzi i andropauzi, Hotel Neptun, Brijuni, 10.09.2011Hotel Neptun, Brijuni, 10.09.2011
Stress Urinary Incontinence Is the Most Common Type in Women Based on Literature Review
Hampel C, et al. Urology. 1997;50(suppl 6A):4-14.
Urinary incontinence affect at least one in every 4 women
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
LITERATURE LITERATURE REVIEWSREVIEWS
LARGE-SCALE LARGE-SCALE SURVEYSSURVEYS
Urinary incontinence is prevalent, bothersome …but underreported: only 31 -
45% seek help
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
Overall rate 31%
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
Koelbl et al 1987 Obstet Gynecol
Before application after application
6 o’clock 3 o’clock 9 o’clock
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)
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 TISSUESYNTHETIC 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
SYNTHETIC BULKING AGENTS IN URETHRAL TISSUESYNTHETIC BULKING AGENTS IN URETHRAL TISSUE
The Bulkamid® Kit
Bulkamid ® Cystoscope2 prefilled 1 cc. Bulkamid® syringes
2 needles 23 G
1 irrigation set
1 optic 0˚
Light cable(not included in the kit)
Migration after 6 months
Pannek , J Urol 2001:166,1350
250-300 um
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 INJECTIONULTRASOUND GUIDED INJECTION
Skeletal muscle portion was obtained from a small open cut biopsy Skeletal muscle portion was obtained from a small open cut biopsy of the non–dominant biceps muscleof the non–dominant biceps muscle
Myoblast isolation and expansion was performed in GMP cerified Myoblast isolation and expansion was performed in GMP cerified cell-processing cell-processing laboratory Innovacell laboratory Innovacell Biotechnologie AG, Innsbruck, Austria
Autologus myoblast suspension was injected under transurethral ultrasound deviceAutologus 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
EXCLUSION CRITERIAEXCLUSION CRITERIA
UUrge incontinencerge incontinence
Descensus or prolapsDescensus or prolaps
Any sign of inflamationAny sign of inflamation
Serious sistemic diseasesSerious sistemic diseases
Previous antiincontinence Previous antiincontinence surgerysurgery
INCLUSION CRITERIAINCLUSION CRITERIA
Urodinamic proven pure Urodinamic proven pure SUI (standard ICS protocol)SUI (standard ICS protocol)
Age 50-70Age 50-70
Normal US examinationNormal US examination
Normal status gyn.Normal status gyn.
38 patients38 patients
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)
PreoperativePreoperative PostoperativePostoperative pp
BaselineBaseline ESES Myoblasts + ESMyoblasts + ES
No. of patientsNo. of patients 3838 3838 3737
UIEUIE 13 (4-41)13 (4-41) 12 (1-35)12 (1-35) 5 (0-33)5 (0-33) <0.0001<0.0001
UISUIS 24 (4-67)24 (4-67) 18.5 (2-49)18.5 (2-49) 5 (0-33)5 (0-33) <0.0001<0.0001
Stress test negativeStress test negative 00 11 2929 <0.0001<0.0001
PGI-I curedPGI-I cured improvedimproved unchanged unchanged
0000
3838
0077
3131
55292933
<0.0001<0.0001
I-QI-QOOLL 56.5 (28-92)56.5 (28-92) 63 (29-99)63 (29-99) 78 (41-105)78 (41-105) <0.0001<0.0001
VASVAS 8 (3-10)8 (3-10) 7 (4-10)7 (4-10) 3 (0-9)3 (0-9) <0.0001<0.0001
The numeric variables are presented as median values (range). The numeric variables are presented as median values (range). PP values are for ES values are for ES vsvs. Myoblasts + ES. Myoblasts + ES
IMPROVEMENT FROM BASELINE
VAS- visual analog scale of the degree of sufferingQOL- quality of life questionnaireUIE- 3-day bladder diaries for urinary incontinence episodesUIS- amount of leaked urine measured semiquantitative
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
URINARY INCONTINENCE should not be viewed as a normal part of aging
it should be viewed as treatable
Thank you for the attention
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