Aims: The aim of this study was the safety assessment of urethra injections of autologous total nucleated cells (TNCs) along with platelets, which focused on the outcome over a 6 month period.
Methods: An open, prospective study was conducted on 9 patients with severe stress urinary incontinence (SUI). At the baseline, 1, 3, and 6 months after external urethral sphincteric and submucosal injections of autologous TNCs along with platelets, the patients were assessed according to cough tests, Q-Tip tests, urodynamics, 1 hr pad tests, upper tract ultrasonography (UTU), post voiding residue (PVR), International Consultation on Incontinence Questionnaire-Urinary incontinence (ICIQ-UI), and International Consultation on Incontinence Modular Questionnaire-Quality of Life (ICIQ-QOL). On the 3rd month post-injection, the maximum urethral closure pressure (MUCP) and abdominal leak point pressure (ALPP) were measured in one patient with intrinsic sphincteric deficiency (ISD; the baseline: ALPP < 60 and MUCP < 30 cmH(2)O).
Results: No complications were observed after injection. At 6-months' follow up (F/U), all the patients considered themselves clinically cured with eight women completely continent and one marked improvement. Mean age was 48.9 ± 13.8 years. Before the injection, urodynamics, UTU, and PVR were normal and cough tests, 1 hr pad tests were positive in patients. At 1, 3, and 6 months post-injection, there was a significant improvement in ICIQ-UI, ICIQ-QOL (P < 0.05). UTU and PVR were normal, cough tests, and 1 hr pad tests were negative, except for ISD patient with severe coughs (at month 3: ALPP = 92 and MUCP > 30 cmH(2)O).
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 with marked improvement after 6 months F/U.
Copyright © 2012 Wiley Periodicals, Inc.