title: Comprehensive evaluation of anterior elevate system for the treatment of anterior and apical pelvic floor descent: 2-year followup.
abstract: OBJECTIVE
  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.
  
  
  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.
authors: Virginia Urology Center for Incontinence and Pelvic Floor Reconstruction, Richmond, Virginia. Electronic address: derapp@yahoo.com.
authors: David E
authors: DE
authors: Rapp
authors: Virginia Commonwealth University School of Medicine, Richmond, Virginia.
authors: Ashley B
authors: AB
authors: King
authors: Virginia Urology Center for Incontinence and Pelvic Floor Reconstruction, Richmond, Virginia.
authors: Bruce
authors: B
authors: Rowe
authors: Virginia Commonwealth University School of Medicine, Richmond, Virginia.
authors: Jeff P
authors: JP
authors: Wolters
mesh_terms: D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D056887:Pelvic Organ Prolapse / Q000150:complications / Q000601:surgery*; D011788:Quality of Life; D012189:Retrospective Studies; D013526:Surgical Mesh; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014550:Urinary Incontinence, Stress / Q000209:etiology / Q000601:surgery
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