title: A novel cell therapy for stress urinary incontinence, short-term outcome.
abstract: OBJECTIVE
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Urology, Imam Reza Academic Hospital, Mashhad University of Medical Sciences, Mashhad, Iran.
authors.forename: Maliheh Keshvari
authors.initials: MK
authors.lastname: Shirvan
authors.forename: Daryoush Hamidi
authors.initials: DH
authors.lastname: Alamdari
authors.forename: Mohammadreza Darabi
authors.initials: MD
authors.lastname: Mahboub
authors.forename: Alireza
authors.initials: A
authors.lastname: Ghanadi
authors.forename: Hamid Reza
authors.initials: HR
authors.lastname: Rahimi
authors.forename: Alexander M
authors.initials: AM
authors.lastname: Seifalian
mesh_terms: D000328:Adult; D001792:Blood Platelets / Q000502:physiology; D002469:Cell Separation; D064987:Cell- and Tissue-Based Therapy / Q000379:methods*; D005260:Female; D006801:Humans; D007267:Injections; D008875:Middle Aged; D010298:Parity; D010865:Pilot Projects; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014521:Urethra; D014549:Urinary Incontinence / Q000503:physiopathology / Q000628:therapy*; D014563:Urodynamics / Q000502:physiology