Hypothesis / aims of study
The Elevate™ Anterior mesh is designed to correct the anterior vaginal wall defect by providing level 1 and 2 support via a single incision and transvaginal approach. This study aims to examine the objective and subjective outcomes following severe (Grades 3 and 4) cystourethrocele repair using the Elevate™ Anterior kit by a single surgeon in our centre, looking at its safety, efficacy, and associated complication rates.
Study design, materials and methods
This is an update to our study presented at ICS 2018 in Philadelphia, which showed excellent outcomes with very low complication rates. In this update, we are studying 213 patients with Grade 3 and 4 cystourethrocele who underwent a single incision transvaginal mesh using the Elevate™ Anterior Kit from 01 October 2011 to 28February 2014.Peri- and post-operative complications were recorded, and follow up intervals arranged at 1, 6, 12, 24, 36, 48, and 60 months post-surgery. A standardised questionnaire directed at both urinary, pain and recurrence symptoms was used for all patients during each follow up visit. Speculum and vaginal examinations were performed in all patients at each follow up visit to assess for objective cure and for detection of complications, including mesh extrusions. The primary outcome was to assess the cure rate defined as a patient with cystourethrocele less than or equal to Grade 1.
Two hundred and thirteen patients were studied and the mean age was 64.9 years, with 205 (96.2%) patients being menopausal. Majority of these patients (99.1%) had previous vaginal deliveries. Approximately 20% and 30% of patients had concomitant urge urinary incontinence and stress urinary incontinence respectively. Subjective and objective cure rates at 60 months were 97.3% and 96.7% respectively. Seven (3.3%) intra-operative complications were recorded with 4 having excessive blood loss more than 500 mls, 2 having rectal perforation during concomitant posterior repair for rectocele, and 1 having bladder perforation. Post-operatively, 5 (2.3%) had fever, 1 (0.5%) had hypotension requiring fluid challenge and blood transfusion, and 1 (0.5%) had voiding difficulty associated with urinary tract infection.
Interpretation of results
At 60 months, 150 patients (70.4%) completed the five-year followup. There were 1 (0.7%) and 3 (2.0%) cases of de novo stress and urge incontinence respectively. There was a single case of mesh extrusion which was managed conservatively. As for recurrent prolapse, 2 (1.3%) had Grade 2 cystocele, 1 (0.7%) had Grade 2 rectocele, 1 (0.7%) had Grade 3 rectocele, and 3 (2.0%) had Grade 2 vault prolapse. There were no subjective symptoms of pelvic pain or dyspareunia. The overall subjective and objective outcomes remained excellent with very low complication rates.