Long-term Outcomes With Macroplastique in Women With Stress Urinary Incontinence Secondary to Intrinsic Sphincter Deficiency.

OBJECTIVE:To evaluate the long-term outcomes of polydimethylsiloxane (Macroplastique (MPQ)) in women with stress urinary incontinence (SUI) secondary to intrinsic sphincter deficiency (ISD) using validated questionnaires. METHODS:Following IRB approval, charts of non-neurogenic women with SUI secondary to ISD who underwent MPQ injection were reviewed from a prospectively maintained database. ISD was defined as positive stress test with a well-supported urethra and low Valsalva leak point pressure when available. Excluded were women with follow-up <5years. Baseline data included validated questionnaire scores (UDI-6 question 3 (0-3), VAS Quality of Life, Incontinence Impact Questionnaire (IIQ-7)) and urodynamic study findings. Patients were followed with same questionnaires and three-dimensional ultrasound evaluating volume/configuration of MPQ. All three-dimensional ultrasound measurements were performed by the same imaging team blinded to clinical outcomes. Outcomes were evaluated in four groups based on prior SUI treatment. Success was defined as UDI-6 question 3 score of 0-1 and not requiring additional anti-incontinence therapy at the last visit after the last MPQ injection. RESULTS:From April 2011-December 2016, 106 patients (median age 67) met study criteria. Median follow-up time was 7.4years. Median MPQ injected was 5 mL. Overall success was 43%, with 54% successful after one injection and 46% requiring ≥2 injections. Across all groups, patients had improvement in Quality of Life and IIQ-7 Question 7 (frustration). Among the failure group, 17% opted for a secondary autologous sling procedure. CONCLUSION:MPQ demonstrated long-term favorable outcomes in a subset of women with SUI secondary to ISD.