Periurethral autologous fat injection as treatment for female stress urinary incontinence: a randomized double-blind controlled trial.
OBJECTIVE
We evaluated the effectiveness of periurethral autologous fat injection as treatment for female stress urinary incontinence.


METHODS
Women with stress incontinence were randomized in a double-blind fashion to receive periurethral injections of autologous fat (treatment group) or saline (placebo group). After injection patients were evaluated monthly for 3 months by a validated standardized incontinence questionnaire, 1-hour pad test and cough test. Patients who remained incontinent were offered repeat injection using the same initial agent to a maximum of 3 injections. Every 3 months after injection patients were assessed by a standardized questionnaire, pad test, cough test and urodynamics. Those who did not qualify for repeat injection at 3 months were then followed 6, 9, 12, 18 and 24 months or until failure.


RESULTS
Of the 68 women enrolled 35 received fat and 33 received saline injections. The groups were comparable in terms of baseline parameters. A total of 56 patients completed the study, including 27 in the fat and 29 in the placebo group, for a total of 189 injections (91 fat and 98 saline). At 3 months 6 of 27 (22.2%) and 6 of 29 (20.7%) women were cured or improved in the fat and saline groups, respectively. Complications included cystitis in 9 of 189 injections, urinary retention in 6 in the fat injection group, urge incontinence in 9 of 68 patients and pulmonary fat embolism resulting in death in 1 of 189 procedures.


CONCLUSIONS
In this study periurethral fat injection did not appear to be more efficacious than placebo for treating stress incontinence.
Lee
P E
PE
Department of Obstetrics and Gynecology, University of Toronto, Sunnybrook and Women's College Health Sciences Centre and Mount Sinai Hospital, Toronto, Ontario, Canada.
Kung
R C
RC
Drutz
H P
HP
D000273:Adipose Tissue / Q000637:transplantation*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007267:Injections; D008875:Middle Aged; D013997:Time Factors; D014182:Transplantation, Autologous; D014550:Urinary Incontinence, Stress / Q000601:surgery*