[Prospective evaluation of intrasphincteric injections of autologous muscular cells in patients with stress urinary incontinence following radical prostatectomy].
OBJECTIVE
Cell therapy for urinary incontinence management has been experienced in animals with encouraging results, but studies in human beings are lacking. Our primary objective was to assess the safety of intrasphincteric injections of autologous muscular cells in patients with postprostatectomy incontinence (PPI). Secondary objectives focused on complications efficacy.


METHODS
We conducted an open, prospective study in a single center on 12 patients presenting PPI. Patients underwent intrasphincteric injections of autologous muscular cells isolated from a biopsy of deltoid muscle. The primary endpoint was the Q(max) variation at the three month visit in order to assess potential bladder outlet obstruction. Secondary endpoints assessed side effects and efficacy parameters based on symptoms, quality of life score, voiding diary, pad-test, and urethral pressure profile at one, two, three, six and 12 months after injection.


RESULTS
No immediate complication occurred and no significant variation was noted on Q(max). The only side effects possibly product-related were three cases of urinary tract infection treated by antibiotics. An acceptable safety and tolerability of the procedure whatever the injected dose of muscular cells was demonstrated. Results on efficacy after one year were heterogeneous, with 4/12 patients describing reduced urine leakage episodes, 1/12 patient presenting increased maximal closure pressure, and 8/12 patients showing improvement on pad-test.


CONCLUSIONS
Cell therapy consisting of intrasphincteric injections of autologous muscular cells in patients with PPI was a feasible and safe procedure. The results point out that some subjects may positively respond to this procedure, but clinical efficacy remains to be confirmed.
Service d'urologie, hôpital Tenon, AP-HP, université Paris VI, 4, rue de la Chine, 75970 Paris cedex 20, France. jncornu@hotmail.fr
J-N
JN
Cornu
C
C
Doucet
P
P
Sèbe
C
C
Ciofu
S
S
Gil Diez de Medina
G
G
Vallancien
G
G
Amarenco
O
O
Cussenot
C
C
Pinset
F
F
Haab
D000368:Aged; D057645:Deltoid Muscle; D005240:Feasibility Studies; D005500:Follow-Up Studies; D006801:Humans; D015552:Injections, Intralesional; D008297:Male; D008875:Middle Aged; D032342:Muscle Cells / Q000637:transplantation*; D011446:Prospective Studies; D011468:Prostatectomy / Q000009:adverse effects*; D011788:Quality of Life; D018570:Risk Assessment; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014521:Urethra; D014550:Urinary Incontinence, Stress / Q000209:etiology* / Q000601:surgery*