Aims: The aim of this study was the safety assessment of urethra injections of autologous total nucleated cells (TNCs) along with platelets, and focused on outcome for six months.
Methods: An open, prospective study was conducted on 9 patients presenting severe Stress urinary Incontinence (SUI). At the baseline, 1, 3, 6 months after external urethral sphincteric and submucosal injections of autologous TNCs along with platelets, the patients were assessed according to cough test, Q-Tip test, urodynamic, 1 hour pad test, upper tract ultrasonography (UTU), post voiding residue (PVR) , laboratory tests , U/A, U/C, ICIQ- UI and ICIQ- QOL. At third month post-injection, the maximum urethral closure pressure (MUCP) & abdominal leak point pressure (ALPP) were measured in one patient with ISD (the baseline: ALPP < 60 CmH2O, MUCP < 30 CmH2O).
Results: No complications were observed after injection. At 6-months' F/U, all the patients considered themselves clinically cured, with 8 women were completely continent and one marked improvement. Mean age was 48.9 ± 13.8 years. Before the injection, urodynamic, UTU and PVR were normal and cough Test, 1 hour pad test were positive in patients. At 1, 3, 6 months post-injection, there was a significant improvement in ICIQ- UI, ICIQ- QOL (P<0.05). UTU, PVR were normal, cough Test & 1 hour pad test were negative, except for ISD patient in severe coughs (at third month: ALPP=92 CmH2O, MUCP> 30 CmH2O).
Conclusion: Cell therapy consisting of intrasphincteric and submucosal injections of autologous TNCs along with platelets in SUI patients is a feasible and safe procedure. The results point out those subjects cured or marked improvement in six months F/U.