A French multicenter clinical trial of SPARC for stress urinary incontinence.

Abstract

To evaluate the safety and efficacy of the SPARC procedure in women with genuine stress urinary incontinence.
We conducted a prospective multicenter trial of a suprapubic approach to suburethral polypropylene (SPARC) taping for the treatment of genuine stress urinary incontinence. Between June 2001 and June 2002, 104 consecutive women (mean age 58.7 years) underwent SPARC in three centers. All the women had urethral hypermobility preoperatively. Detrusor instability was ruled out by cystometry. The women were evaluated 1, 3, 6 and 12 months postoperatively. The objective cure rate was evaluated by clinical and urodynamic examination, and the subjective cure rate was assessed using the Kings and Bristol questionnaire.
The mean follow-up time was 11.9+/-1.9 months (range 8 to 20 months). The mean operating time was 30 min (25-50 min). Most of the patients received general anesthesia (48%). The overall complication rate was 44.2% (46/104). The perioperative complication rate was 10.5%, including 11 bladder injuries. A significant difference in the bladder injury rate was observed between women with and without previous incontinence surgery (respectively 4/11, 36.3% versus 7/93, 7.5%; p<0.001). No hemorrhaging occurred. The early postoperative complication rate was 22.1%. The main complication was voiding disorders (11 patients), which necessitated intermittent self-catheterization for less than 15 days (1.3+/-1.1 days, range 1 to 10 days). The late postoperative complication rate was 11.5%, including de novo urge symptoms in 12 women. The objective cure rate was 90.4%. No difference was found between patients with genuine stress incontinence and those with mixed incontinence. The subjective cure rate was 72%. The objective and subjective cure rates differed significantly (p<0.05). The subjective cure rate among patients with de novo urge symptoms was 58%.
The SPARC procedure is a safe and effective treatment for women with stress urinary incontinence, despite a high incidence of de novo urge symptoms.