Introduction and hypothesis: Cell therapy for stress urinary incontinence (SUI) management has been experienced with encouraging results.
Methods: We conducted an open prospective study on 12 women presenting severe SUI with fixed urethra, after previous failed surgical management. Patients underwent intrasphincteric injections of autologous progenitor muscular cells isolated from a biopsy of deltoid muscle. Primary endpoint focused on safety (measurement of Q(max) variation after 3 months). Secondary endpoints assessed side effects and efficacy.
Results: No variation was diagnosed on Q(max) measurements. Efficacy data show that three of 12 patients are dry at 12 months, seven other patients are improved on pad test but not on voiding diary, and two patients were slightly worsened by the procedure. Quality of life was improved in half of patients.
Conclusions: Cell therapy for severe multioperated cases of SUI is a mini-invasive, feasible, and safe procedure that can improve urinary condition in as a second line therapy.