ORIGINAL ARTICLE Intrasphincteric injections of autologous muscular cells in women with refractory stress urinary incontinence: a prospective study Philippe Sèbe & Christelle Doucet & Jean-Nicolas Cornu & Calin Ciofu & Pierre Costa & Sixtina Gil Diez de Medina & Christian Pinset & Francois Haab Received: 10 June 2010 / Accepted: 10 August 2010 / Published online: 7 September 2010 # The International Urogynecological Association 2010 Abstract 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. Keywords Women urinary incontinence . Cell therapy . Myoblast . Intrinsic sphincter deficiency Abbreviations BMI Body mass index ISD Intrinsic sphincter deficiency PFME Pelvic floor muscle exercises PVR Post-voiding residual Q max Maximum urinary flow rate QoL Quality of life SUI Stress urinary incontinence UI Urinary incontinence UPP Urethral pressure profile UTI Urinary tract infection Introduction Urinary incontinence (UI) is defined by the international continence society as a complaint of any involuntary leakage of urine [1]. Among millions of women suffering from UI in the world, it has been shown that a majority of them suffer from stress urinary incontinence (SUI) [2]. SUI is associated with social impact and a reduced long-term Philippe Sèbe and Christelle Doucet have contributed equally to this work. P. Sèbe : J.-N. Cornu (*) : C. Ciofu : S. G. D. de Medina : F. Haab Department of Urology, Tenon Hospital, Groupe Hospitalo-Universitaire EST, Assistance Publique-Hôpitaux de Paris (AP-HP), University Paris VI, 4 rue de la Chine, 75970 Paris Cedex 20, France e-mail: jncornu@hotmail.fr C. Doucet CELOGOS, 15 rue Béranger, 75003 Paris, France P. Costa Urology and Andrology Unit, Nîmes Hospital, Place du Pr. Debré, 30029 Nîmes, France C. Pinset CECS/Istem, Genopole Campus 1, 5 rue Henri Desbruères, Evry, France Int Urogynecol J (2011) 22:183–189 DOI 10.1007/s00192-010-1255-5