PURPOSE: To evaluate the 60-month outcome of the Macroplastique Implantation System (MIS) for the treatment of female stress urinary incontinence (SUI) caused by intrinsic sphincter deficiency evaluated by objective and subjective measures, including Quality of Life (QoL) impact. PATIENTS AND METHODS: Twenty-one women, mean age 47.4 years, with urodynamically diagnosed intrinsic sphincter deficiency were enrolled. They were assessed preoperatively by physical examination, QoL (King's Health Questionnaire), Stamey grading of incontinence, pad usage, 1-hour pad-weight test, and urodynamic testing. Patients underwent periurethral injection of MIS under local anesthesia. After 24-month follow-up, six patients were discharged from the group, and the remaining 15 patients were reassessed by means of objective and subjective parameters at 6, 12, 24, and 60 months after last treatment. RESULTS: Patients' QoL improved in all domains throughout the study. The overall subjective success rate was 80%. At 60 months, pad usage was reduced from a mean of 3.5/day to 0.9/day, and the 1-hour pad weight decreased from 53.8 to 5.9 g. Valsalva leak-point pressure testing demonstrated a 73.3% rate of cure/improvement. There was no significant statistical difference assessed by Stamey grading and objective cure at 6, 12, 24, and 60 months of follow-up. The data showed a stable overall outcome from 6 to 60 months. CONCLUSION: The MIS produced promising long-term subjective and objective outcomes, as well as long-lasting improvements in QoL. It should be considered a good option for certain cases of female SUI.
PURPOSE: To evaluate the 60-month outcome of the Macroplastique Implantation System (MIS) for the treatment of female stress urinary incontinence (SUI) caused by intrinsic sphincter deficiency evaluated by objective and subjective measures, including Quality of Life (QoL) impact. PATIENTS AND METHODS: Twenty-one women, mean age 47.4 years, with urodynamically diagnosed intrinsic sphincter deficiency were enrolled. They were assessed preoperatively by physical examination, QoL (King's Health Questionnaire), Stamey grading of incontinence, pad usage, 1-hour pad-weight test, and urodynamic testing. Patients underwent periurethral injection of MIS under local anesthesia. After 24-month follow-up, six patients were discharged from the group, and the remaining 15 patients were reassessed by means of objective and subjective parameters at 6, 12, 24, and 60 months after last treatment. RESULTS:Patients' QoL improved in all domains throughout the study. The overall subjective success rate was 80%. At 60 months, pad usage was reduced from a mean of 3.5/day to 0.9/day, and the 1-hour pad weight decreased from 53.8 to 5.9 g. Valsalva leak-point pressure testing demonstrated a 73.3% rate of cure/improvement. There was no significant statistical difference assessed by Stamey grading and objective cure at 6, 12, 24, and 60 months of follow-up. The data showed a stable overall outcome from 6 to 60 months. CONCLUSION: The MIS produced promising long-term subjective and objective outcomes, as well as long-lasting improvements in QoL. It should be considered a good option for certain cases of female SUI.