EFFICACY AND SAFETY OF ANTERIOR AND APICAL ELEVATE® SYSTEM ON APICAL AND ANTERIOR COMPARTMENT PROLAPSE REPAIR: 2-YEARS FOLLOW-UP

Authors and affiliations:                                                                                                                                                
Vikiela Galica1; Daniele Castellani1; Pietro Saldutto1;  Daniela Biferi1; Giovanni Giovanditti1; Cristian Cicconetti1; Giuseppe Paradiso Galatioto1; Carlo Vicentini.
1 Department of Health Science, University of L'Aquila, Teramo Hospital, Italy

Topic: Pelvic organ prolapse surgery.
Abstract                                                                                                                                  
Objective. To evaluate the effectiveness and safety on medium-term of transvaginal Anterior Elevate® mesh kit system (AES) in women with symptomatic stage 3 or 4 anterior and/or apical pelvic organ prolapse (POP).                                                                                                        
Materials and Methods. This is a retrospective, monocentric study enrolling 56 women experiencing symptomatic anterior vaginal prolapse with or without apical descent (POP-Q stage 3 or 4). All women received an AES implantation. Primary endpoint was anatomic correction of prolapse; success was defined as POP-Q stage ≤1 or asymptomatic stage 2. Secondary endpoints were quality-of-life (QOL) results and patient safety outcomes, which were assessed by 3 validated self-reporting questionnaires at baseline and annually: International Consultation on Incontinence questionnaire on urinary incontinence (ICIQ-UI) short form, International Consultation on Incontinence questionnaire on vaginal symptoms (ICIQ-VS) and  prolapse-quality of life questionnaire (P-QOL).                                                                                                               
Results. Mean operative time was 47.3 (± 8) minutes. There was no bladder and rectal injuries. Vaginal mesh exposure was present in 3 (5,3%) patients. Very good anatomical outcomes were seen, with one (1,8%) failure at 6-months, 4 (7,1%) at 1-year, 6 at 2-years (10,7%). Statistically significant improvements were seen in the ICIQ-VS and P-QOL questionnaires throughout follow-up.                                                                                                                                        
Conclusion. AES is an attractive minimally-invasive transvaginal procedure with good evidence related to mid-term safety and efficacy.
References

  1. Maher C, Baessler K, Barber M et al. Surgical management of pelvic organ prolapse. In: Abrams C, Khoury W (eds) 5th International Consultation on Incontinence. Health Publication Ltd, Paris; 2013. 
  2. Samuelsson EC, Victor FT, Tibblin G, Svärdsudd KF. Signs of genital prolapse in a Swedish population of women 20 to 59 years of age and possible related factors. Am J Obstet Gynecol. 1999;180 (2 Pt 1):299–305.
  3. Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010;116(5):1096–100. 
  4. Subak LL, Waetjen LE, van den Eeden S, et al. Cost of pelvic organ prolapse surgery in the United States. Obstet Gynecol. 2001;98:646-651.
  5. Rane A, Iyer J. Pelvic Organ Prolapse: Anterior Compartment—Kits and Customised Repairs. In: Badlani G H. Minimally Invasive Therapy for Urinary Incontinence and Pelvic Organ Prolapse. Springer New York Heidelberg Dordrecht, London; 2014.
  6. Bump RC, Mattiasson A, Bo K et al: The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 1996; 175: 10-17.
  7. Abrams P, Cardozo LD, Fall M et al: The standardization of terminology of lower tract function: report from the Standardisation Subcommittee of the International Continence Society. Neurourol Urodyn. 2002; 21(2): 167-178.
  8. Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, AbramsP. ICIQ: A Brief and Robust Measure for Evaluating the Symptoms and Impact of Urinary Incontinence. Neurourol Urodyn. 2004; 23:322-330.