One year follow‐up on the SPARC sling system for the treatment of female urodynamic stress incontinence

Abstract

To evaluate the safety and efficacy of the SPARC sling in women with urinary incontinence. Women who presented with urinary incontinence symptoms were included in this prospective study. In total, 103 women underwent evaluation of subjective and objective cure rates, quality of life and urodynamic parameters following the SPARC procedure. The objective cure rate, defined as a pad weight test less than 1 g and negative cough stress test, was 84.4% at 12 months. Subjective cure rates, defined as no usage of pads/no urine loss during daily activities, were also encouraging: 75.0% at 12 months. Quality of life evaluation included asking patients to rate the amount of bother caused by their incontinence symptoms on a scale from 0 to 100. Preoperatively, the average was 76.7, dropping to 15.9 at 12 months. At 6 months, 93.7% (75/79) were 'very satisfied' and 5.1% (4/79) were 'satisfied;' one patient was 'dissatisfied' (1.2%, 1/79). Seventy-eight of 79 patients (98.7%) would recommend the procedure to a friend and undergo the procedure again. Patients returned to inside work an average of 1.4 days and to outside work 5.4 days after the procedure. The maximum flow rate decreased from a mean of 43.4 mL/s preoperatively to 37.08 mL/s at 12 months postoperatively (P = 0.049). Detrusor pressure at maximum flow and maximal urethral closure at rest increased from 16.94 and 50.85 cmH(2)O preoperatively to 21.69 and 60.61 cmH(2)O at 12 months, respectively (P = 0.015; P < 0.001). There were few postoperative complications, with no reported infections, erosions or hematomas. This prospective study demonstrates that the SPARC suprapubic sling is a safe and effective treatment for female stress urinary incontinence. Both objective and subjective measures of success were achieved, with low complication rates. Quality of life and urodynamic parameters were improved. The SPARC method provides safe and highly effective treatment for female stress urinary incontinence at one year.