Presentation on theme: "Stem cells therapy for urinary incontinence in eldery women"— Presentation transcript:
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, SloveniaVI 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.1REFERENCES: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 REVIEWSLARGE-SCALE SURVEYSKEY 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 prevalenceof UI (when using the ICS definition of “the complaint of any involuntaryleakage 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 years8.5 % < 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 application6 o’clock o’clock o’clock
9 The ideal bulking agent properties: Non-immunogenicNon long term side effectPermanentHigh safety profileNon-migratoryNon-erosiveNon-inflammatoryEasily storedEasily injectedPainless
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 set2 needles 23 G2 prefilled 1 cc. Bulkamid® syringesBulkamid ® Cystoscope
14 DURASPHERE Migration after 6 months 250-300 um Pannek , J Urol 2001:166,1350
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.
22 THE IMPACT OF LOCALLY INJECTED STEM CELLS FOR THE TREATMENT OF FEMALE STRESS URINARY INCONTINENCE PROSPECTIVE RESEARCH TRIAL DEPARTEMENT OF GYNECOLOGY UCC LJUBLJANAINCLUSION CRITERIAUrodinamic proven pure SUI (standard ICS protocol)Age 50-70Normal US examinationNormal status gyn.38 patientsEXCLUSION CRITERIAUrge incontinenceDescensus or prolapsAny sign of inflamationSerious sistemic diseasesPrevious antiincontinencesurgery
23 Methods of evaluationUIS- amount of leaked urine measured semiquantitativeUIE- UI episodes count from a 3 day voiding diaryQOL- quality of life questionnaireVAS- visual analog scale of the degree of sufferingPGI-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)PreoperativePostoperativepBaselineESMyoblasts + ESNo. of patients3837UIE13 (4-41)12 (1-35)5 (0-33)<0.0001UIS24 (4-67)18.5 (2-49)Stress test negative129PGI-I curedimprovedunchanged73153I-QOL56.5 (28-92)63 (29-99)78 (41-105)VAS8 (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 sufferingQOL- quality of life questionnaireUIE- 3-day bladder diaries for urinary incontinence episodesUIS- amount of leaked urine measured semiquantitative
26 STEM CELLS IN UROGYNECOLOGY The use of embrionic stem cells is limited due to unresolved medicolegal questionsWhen using stem cells of adult human being there are no medicolegal dilemas
27 DILEMAS TO BE RESOLVEDTO 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 ALTERATIONETHICAL ASPETSC AS THIS IS EXPERIMENTAL SURGERYMEDICOLEGAL ASPECTS IN CASE OF FAILURECOSTSLEARNING 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 PATIENTSDON OSTERGARD, IUGA ANNUAL MEETING CANCUN 2007
29 it should be viewed as treatable TAKE HOME MESSAGEURINARY INCONTINENCEshould not be viewed as a normal part of agingit should be viewed as treatable