Comprehensive evaluation of anterior elevate system for the treatment of anterior and apical pelvic floor descent: 2-year followup

Abstract

Purpose: The Elevate® Anterior and Apical Prolapse Repair System is a polypropylene mesh that is anchored through sacrospinous ligament and obturator fascia fixation points. We present a comprehensive evaluation of this prolapse repair system through 2 years with a focus on safety, operative characteristics, and anatomical, subjective and quality of life outcomes.

Materials and methods: A total of 42 women underwent repair of stage II or greater anterior/apical compartment prolapse using the repair system, of whom 2 were lost to followup. Anatomical outcomes were assessed using POP-Q (Pelvic Organ Prolapse Quantification) staging. Subjective and quality of life outcomes were assessed by the validated ICIQ (International Consultation on Incontinence Questionnaire)-VS (Vaginal Symptoms), ICIQ-FLUTS (Female Lower Urinary Tract Symptoms) and IIQ-7 (Incontinence Impact Questionnaire-7). Additional outcomes included a 3-day bladder diary and cough test with outcomes assessed preoperatively, at 6 weeks, and at 1 and 2 years.

Results: Mean ± SD blood loss was 93 ± 55 cc and mean operative time was 58 ± 27 minutes. POP-Q points Aa, Ba and C improved from 0.9, 0.8 and -1.3 preoperatively to -2.1, -2.7 and -6.1 cm at 2 years, respectively (each p <0.05). Four patients experienced anatomical recurrence, which was associated in 2 with symptomatic recurrence on the ICIQ-VS. Statistically significant improvements in the ICIQ-VS, ICIQ-FLUTS and IIQ-7 were seen throughout followup. Adverse events included leg pain, vaginal exposure and urinary retention in 1, 2 and 5 patients, respectively.

Conclusions: The Elevate Anterior and Apical Prolapse Repair System was associated with good anatomical restoration and significant improvements in validated symptom and quality of life indexes through 2 years of assessments. Our experience suggests that the system is a safe, effective surgical procedure in appropriately selected patients. Long-term followup is important, given the FDA (Food and Drug Administration) warning regarding the use of surgical mesh in the repair of pelvic organ prolapse.

Keywords: AES; Elevate Anterior and Apical Prolapse Repair System; MUS; POP; QOL; SUI; TVT-O; TVT™ Obturator System; UI; UUI; cystocele; female; mid urethral sling; pelvic organ prolapse; quality of life; stress UI; surgical mesh; urge UI; urinary bladder; urinary incontinence.