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Stem cells therapy for urinary incontinence in eldery women

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1 Stem cells therapy for urinary incontinence in eldery women
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
KEY POINT: Among published studies in which types of incontinence were classified, SUI was the most common type in females. ADDITIONAL INFORMATION: A literature search completed by Hampel et al1 reviewed 48 studies published between 1954 and 1995. In 21 of the 48 studies, the type of incontinence in females was classified by symptoms or urodynamic findings, showing that SUI is the most common type of UI in females.1 REFERENCES: 1. Hampel C, et al. Urology. 1997;50(suppl 6A):4-14. Hampel C, et al. Urology. 1997;50(suppl 6A):4-14.

3 Urinary incontinence affect at least one in every 4 women
LITERATURE REVIEWS LARGE-SCALE SURVEYS KEY POINT: Urinary incontinence (UI) affects at least 1 in every 4 women. ADDITIONAL INFORMATION: A literature review in 2003 by Minassian et al. showed that the prevalence of UI (when using the ICS definition of “the complaint of any involuntary leakage of urine”) in women is approximately 25%. This was confirmed by large scale community-based surveys using the same ICS definition such as the Norwegian EPINCONT study published by Hannestad et al. in 2000 and 2 more recent NFO surveys in 4 European countries (Hunskaar et al. 2004) and the US (Kinchen et al. 2003). The prevalence ranged between 25-37% in these 3 surveys. Taken together the data show that at least 1 in every 4 women reports UI when specifically asked about this. 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

4 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

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 THE AGING FEMALE Next 20 years 18% increase of women > 75 years
Urinary incontinence: 11.6% > 65 years 8.5 % < 65 years

7 AGE RELATED CHANGES OF PELVIC FLOOR MUSCLE
Koelbl et al 1987 Obstet Gynecol

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

9 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

10 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)

11 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.

12 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

13 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

14 DURASPHERE Migration after 6 months 250-300 um
Pannek , J Urol 2001:166,1350

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 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 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

23 Methods of evaluation 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) Preoperative Postoperative p Baseline ES Myoblasts + ES No. of patients 38 37 UIE 13 (4-41) 12 (1-35) 5 (0-33) <0.0001 UIS 24 (4-67) 18.5 (2-49) Stress test negative 1 29 PGI-I cured improved unchanged 7 31 5 3 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 STEM CELLS IN UROGYNECOLOGY
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 DILEMAS TO BE RESOLVED 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 QUESTIONS TO BE ANSWERED
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 it should be viewed as treatable
TAKE HOME MESSAGE 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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