Retrospective study comparing two-year outcomes of different vaginal mesh kits: a single tertiary centre experience

Li X1, Han H1, Chua H1

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

Abstract 470
Open Discussion ePosters
Scientific Open Discussion Session 30
Saturday 10th September 2022
11:10 - 11:15 (ePoster Station 4)
Exhibition Hall
Pelvic Organ Prolapse Grafts: Synthetic Surgery
1. KK Women's and Children's Hospital
Online
Presenter
Links

Poster

Abstract

Hypothesis / aims of study
Uterovaginal prolapse has been on the rise over the years owing to silver tsunami and one of the well published methods for treatment uses vaginal mesh kits. However, controversies have arisen stating that mesh repair lead to significant adverse outcomes such as mesh erosion and dyspareunia. This has led to US FDA banning the use of meshes in April 2019 albeit the use of mesh is still available in certain European and Asian countries. The aim of this retrospective study is to compare the two-year objective and subjective outcomes of four different transvaginal mesh kits which has been sequentially used over a time course of 13 years in a single tertiary urogynaecology centre performed mostly by a single surgeon. We will also evaluate the complication rates and quality of life measures associated with the use of each transvaginal mesh kit.
Study design, materials and methods
This was a retrospective case series review of 572 patients with Baden-Walker Grades 3 or 4 anterior compartment prolapse who underwent one of four vaginal mesh kits, namely Gynecare Prolift system (Ethicon, Inc.), Elevate Anterior mesh kit (American Medical System Inc.), Restorelle®Direct Fix(Porges Coloplast) and Uphold system (Boston Scientific) over a period from 1 January 2006 and 30 April 2019. Data on patient demographics, pre-operative symptoms, examination findings and peri-operative outcomes were recorded. Prolapse severity was assessed objectively during pre-operative evaluation and intra-operatively prior to commencement of surgery. Post-operative outcomes including objective and subjective cure rates as well as complications were recorded. An institution based, non-validated standardized questionnaire was used to assess urinary, pain and recurrence symptoms. Pelvic examination was performed at every follow-up visit to assess for any mesh related post-operative complications and document objective cure rate. For ease of presentation, patients who underwent Anterior Prolift will be named Group A, Elevate Group B, Restorelle Group C and Uphold Group D. Data was analysed using Chi Square, Fisher’s Exact and Mann-Whitney U test and this study received ethics approval CIRB 2020/2124.
Results
A total of 572 patients underwent vaginal mesh kit for treatment of anterior compartment prolapse, of which 107 was in Group A, 270 in Group B, 58 in Group C and 137 in Group D. The mean age of patient was between 64.7 and 65.9 years old. Between 19.0% to 27.0% of patients were sexually active. There was no significant difference in the age, BMI, parity, menopause status and months post menopause between the groups.

Most patients complained of a lump at introitus (93.5% to 100%), whilst five had concomitant dyspareunia. Concurrent stress urinary incontinence was reported in 30.8% in Group A, 29.3% in Group B, 39.7% in Group C and 45.3% in Group D. Voiding difficulty was reported in 26.2% in Group A, 18.1% in Group B, 40.4% in the Group C and 12.4% in the Group D.
Pre-operative examination revealed positive stress test in 11.2% of patients in Group A, 2.2% in Group B, 7.0% in Group C and none in Group D. Baden-Walker Grade 3 anterior compartment prolapse was found in 21.5% in Group A, 67.8% in Group B, 63.8% in Group C and 72.3% for Group D. Grade 4 anterior compartment prolapse was found in 72.9% of those in Group A, 32.2% in Group B, 36.2% for Group C and 27.7% for Group D. Concomitant hydronephrosis for those with Grade 4 anterior compartment prolapse was found in 20.5% of patients in Group A, 33.9% in Group B, 28.6% in Group C and 8.8% in Group D. (Table 1)

The mean duration of surgery was between one to two hours. The mean estimated intra-operative blood loss was 76.8± 86.6ml for Group A, 82.1± 230.9ml for Group B, 260.5± 153.5mls for Group C and 221.2± 138.5mls for Group D. Rectal perforation occurred in 4 (1.5%) patients in Group B and none in the other three mesh kits. Bladder perforation occurred in 2(0.7%) patients in Group B, 2 (3.4%) in Group C and 2 (1.5%) in Group D. Five (4.7%) in Group A, six (2.2%) in Group B, 22 (37.9%) in Group C and 41 (29.9%) in Group D experienced post-operative fever.

Two years post-operatively, the follow up rates were 62.6% in Group A, 80.0% in Group B, 82.8% in Group C and 46.7% in Group D. None of the patients complained of a recurrent lump at the introitus. De novo stress urinary incontinence was reported in 8 (11.9%) in Group A, 3 (1.4%) in the Group B, 3 (6.3%) in Group C and 6 (9.4%) in Group D. De novo urgency and urge incontinence was reported in 7 (10.4%) in Group A, 2 (0.9%)in Group B, 3 (6.3%) in Group C and 8 (12.5%) in Group D. Dyspareunia occurred in 1 (2.1%) in the Group C and 1 (1.6%) in the Group D. Overall satisfaction rates were 100% for Group A, C and D and 99.5% for Group B. Subjective cure rates were 100% for Groups B, C and D. Data was not available for Group A. Mesh extrusion occurred in 9 (13.4%) in Group A, none in Group B, 4 (8.3%) in Group C and 2 (3.1%) in Group D. With regards to post-operative anterior compartment prolapse recurrence, 2 (3.0%) occurred in Group A, none in Group B, 2 (4.2%) in Group C and 1 (1.6%) in Group D. Recurrent rectocele occurred in 2 (0.9%) in Group B, 3 (6.3%) in Group C and 1 (1.6%) in Group D. No patients in Group A had rectocele recurrence. Recurrent vault prolapse occurred in 3 patient (4.5%) in Group A, none in Group B, 1 (2.1%) in Group C and 2 (3.1%) in Group D. The overall objective cure rate was 97.0% in Group A, 100% in Group B, 95.8% in the Group C and 98.4% in Group D. (Table 2)
Interpretation of results
In our centre’s experience, there was no significant difference between the various meshes in terms of subjective and objective cure rates and all of them produced highly satisfactory results at two years follow-up. The higher than usual success rates could be contributed by the fact that majority of the procedures was performed by a single surgeon and a select group of subspecialists. This however also introduced a weakness to our paper which was the lack of heterogeneity in an operator dependent procedure. Another reason for the high satisfaction rate would be good patient selection and perioperative counselling and education to improve patient awareness of their condition, the indication for vaginal mesh kit usage and potential risks involved. 
Complication rates were fairly low in our population. Nonetheless, we recognise the potentially devastating complications of extrusion and organ perforation which could lead to significant compromise on patient’s quality of life both short and long term. 
In our population, majority of patients were not sexually active pre-operatively. It is hence difficult to interpret the incidence of post-operative dyspareunia as the numbers are expectedly minimal.
Concluding message
The use of vaginal mesh kits for anterior compartment prolapse repair has been contentious and even banned. However, careful patient selection combined with good surgical experience performed in a high-volume centre can achieve good objective and subjective cure rates with low complications.
Figure 1 Table 1 Preoperative assessment
Figure 2 Table 2 Two year outcomes
Disclosures
Funding None Clinical Trial No Subjects Human Ethics Committee SingHealth Centralized Institutional Review Board Helsinki Yes Informed Consent Yes
05/10/2024 20:14:04