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Adolf Lukanović, M.D., Ph.D. Mija Blaganje, M.D., Department of Gynecology and Obstetrics University Medical Centre, Ljubljana, Slovenia VI hrvatsko-slovenski.

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Presentation on theme: "Adolf Lukanović, M.D., Ph.D. Mija Blaganje, M.D., Department of Gynecology and Obstetrics University Medical Centre, Ljubljana, Slovenia VI hrvatsko-slovenski."— Presentation transcript:

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,

2 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.

3 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: LITERATURE REVIEWS LARGE-SCALE SURVEYS

4 Urinary incontinence is prevalent, bothersome …but underreported: only % 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: Overall rate 31%

5 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

6  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

7 Koelbl et al 1987 Obstet Gynecol

8 Before application after application 6 o’clock 3 o’clock 9 o’clock

9 Non-immunogenic Permanent Non-migratory Non-erosive Non-inflammatory Easily stored Easily injected Painless Non long term side effect High safety profile

10 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)

11 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

12 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 TISSUE

13 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)

14 Migration after 6 months Pannek, J Urol 2001:166, um

15 Lecce 2005

16 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.

17 MUSCLE BIOPSY ULTRASOUND GUIDED INJECTION

18 Skeletal muscle portion was obtained from a small open cut biopsy of the non–dominant biceps muscle

19 Myoblast isolation and expansion was performed in GMP cerified cell-processing laboratory Innovacell laboratory Innovacell Biotechnologie AG, Innsbruck, Austria

20 Autologus myoblast suspension was injected under transurethral ultrasound device

21

22 THE IMPACT OF LOCALLY INJECTED STEM CELLS FOR THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE PROSPECTIVE RESEARCH TRIAL DEPARTEMENT OF GYNECOLOGY UCC LJUBLJANA EXCLUSION CRITERIA  U rge incontinence  Descensus or prolaps  Any sign of inflamation  Serious sistemic diseases  Previous antiincontinence surgery INCLUSION CRITERIA  Urodinamic proven pure SUI (standard ICS protocol)  Age  Normal US examination  Normal status gyn.  38 patients

23  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

24 Characteristics of patients treated with autologous myoblasts at baseline, at completion of preoperative ES cycle and at 6 weeks postoperatively (Myoblasts + ES) PreoperativePostoperativep BaselineES Myoblasts + ES No. of patients UIE 13 (4-41) 12 (1-35) 5 (0-33) < UIS 24 (4-67) 18.5 (2-49) 5 (0-33) < Stress test negative 0129< PGI-I cured improved improved unchanged unchanged < I-QOL 56.5 (28-92) 63 (29-99) 78 (41-105) < VAS 8 (3-10) 7 (4-10) 3 (0-9) < The numeric variables are presented as median values (range). P values are for ES vs. Myoblasts + ES

25 IMPROVEMENT FROM BASELINE 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

26 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

27  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

28 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

29 URINARY INCONTINENCE should not be viewed as a normal part of aging it should be viewed as treatable

30 Thank you for the attention


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