INTRASPHINCTERIC INJECTIONS OF AUTOLOGOUS SKELETAL MUSCLE DERIVED CELLS: LONGTERM RESULTS
BLAGANJE, D. MRAK, A. LUKANOVIC;
DIVISION OF GYNECOLOGY, UNIVERSTY Med. CENTRE LJUBLJANA, LJUBLJANA, Slovenia.
Introduction: Cellular injection therapy has been investigated as a potential alternative to conventional surgical treatment for stress urinary incontinence (SUI). Autologous Skeletal Muscle Derived Cells (SMDC), injected into the external urethral sphincter of SUI women have been previously studied, suggesting that the concept was safe and improved SUI symptoms in the short term (1).
Objective: Objective was to assess long-term outcomes in female SUI patients 5- years after intra-sphincteric injection of autologous SMDC.
Methods: 37 women with primary symptoms of SUI, previously injected with autologous SMDC and followed for 6 months (1,2), were invited to participate at reassessment 5 years after therapy, which consisted of skeletal muscle tissue open biopsy, autologous SMDC (cell count range 1-50 x106) injection into external urethral sphincter and a short cycle of at-home electrical stimulation (ES) to possibly enhance integration of cells after injection. The following objective and subjective measurements were observed through questionaires, 3-day voiding diary, physical examination and tests: urinary incontinence episodes (UIE), the amount of leaked urine measured semiquantitatively (UIS), the number of pads used, the modified Patient Global Impression of Improvement (PGI-I) score, Stress test and Pad test. Pre- and postinjection values were compared.
Results: Among 37 initially treated women (mean age 59 (41-77) years) 27 (73%) answered questionnaires (I-QOL, VAS, PGI-I) and consented to Stress Test. 15 (40%) participated at Pad Test and 14 (38%) completed the voiding diary. Measurements of all observed subjective and objective parameters were significantly improved 5 years following injection in comparison to pre-injection baseline (Wilcoxon signed rank test;p<0,05). Stress test and Pad test were negative in 93,7% and 80% of tested women. According to PGI-I 4 (15%) patients considered themselves cured and 9 (33%) were improved. No correlation between the age of participants, dose (injected SMDC count) and recorded parameters were observed (multivariate tests; p<0,05).
Conclusions: Autologous SMDC injection significantly improves SUI as long as 5 years after therapy.
References: 1. Int J Gynecol Obstet. 2012;117(2):164-7. 2. Int Urogynecol J Pelvic Floor Dysfunct. 2013;24(4):533-5.