Sam Kuykendall*, Sharron Mee, Gary Leach, Los Angeles, CA
INTRODUCTION AND OBJECTIVES: To evaluate our initial results for pelvic organ prolapse (POP) repair using the Anterior Elevate system and determine the early success rate and safety profile.
METHODS: Sixty-three patients have undergone cystocele repair utilizing the Anterior Elevate system (AMS) with an average of 6 months of follow-up (range 2.5 – 13 months). Subjects undergoing concomitant Posterior Elevate repair were included in the study (7; 11%). Seventy percent of patients had a concomitant midurethral sling procedure (40/63). The primary measured outcome was treatment failure defined as recurrence of cystocele grade 2 or higher at any time during the follow-up period using the Baden-Walker system. Quality of life (QOL) was measured on all patients using the Pelvic Floor Impact Questionnaire (PFIQ), the Pelvic Floor Distress Inventory (PFDI), and the Pelvic Organ Prolapse Urinary Incontinence Sexual Function Questionnaire (PISQ-12). SEAPI scores were obtained pre- and post-operatively.
RESULTS: Of the 63 patients, the average age was 67 years (23-84 years) with average 6 months of follow-up (2.5-13 months), gravidity 3.2; parity 2.8; prior hysterectomy 12 (21%); previous POP repair 16 (25%); previous incontinence surgery 7 (11%). There was no significant anatomic recurrence at latest follow-up in any of the patients. There were a total of 9 complications including de novo urgency (2; 3%), recurrent stress incontinence (3; 4.8%), and mesh extrusion (4; 6.3%) and granuloma formation (2; 3%). Two patients elected to have bulking therapy for recurrent SUI and the four mesh extrusions healed with conservative management. Statistically significant improvement was observed in total SEAPI score as well as each individual score component. Pre-operative total SEAPI score average was 3.2 and post-operative score decreased to 0.8 for a 75% improvement (p<0.001). All QOL measures improved significantly from baseline in 41 patients with a minimum of 6 months follow-up (see Table 1). Of those who completed the PISQ-12, 85% reported improvement in sexual function with no dyspareunia.
CONCLUSIONS: Our early Anterior Elevate repair results from one institution provide support for a very safe and effective procedure with very few complications. Our data highlight the improvements made over earlier generation mesh with low extrusion rates and high patient satisfaction.