Treatment of intrinsic sphincter deficiency using the Macroplastique Implantation System: two-year follow-up.

Purpose: To evaluate the 24-month outcome of the Macroplastique Implantation System (MIS) for the treatment of stress urinary incontinence (SUI) using objective and subjective measures, including quality-of-life (QoL) impact.

Patients And Methods: Twenty-one consecutive women with a mean age of 47.4 years and a mean body mass index 26.16 kg/m(2) having urodynamically diagnosed intrinsic sphincter deficiency (ISD) were enrolled. Patients were assessed preoperatively and postoperatively by physical examination, Stamey grading of incontinence, pad usage, pad weight test, and urodynamic measurements. Quality of life was assessed by the King's Health Questionnaire. Patients underwent transurethral injection of the MIS under local anesthesia on an outpatient basis. The mean volume injected was 6.3 mL. The data presented are based on 24-month followup from the last injection, and the patients were considered their own controls.

Results: Patient QoL improved in all domains. Ten patients (47%) considered themselves cured; three (14.3%) thought they were improved, and eight (38.1%) believed the procedure had failed. According to the subjective surgeon Stamey grading, 8 patients (38.1%) were considered cured, 5 (23.8%) improved, and 8 (38.1%) failed. Daily pad usage was reduced from a mean of 4.38 to 1.47. According to the pad weight test, 12 patients (57.1%) were dry and two (9.5%) improved, while in 7 (33.3%), MIS failed. Urodynamic testing demonstrated 10 patients (50%) dry and 5 (25%) improved.

Conclusion: The MIS proved to have an outcome acceptable to patients and surgeons at 24-month followup. The procedure can be performed easily under local anesthesia.