Hypothesis / aims of study
Following the FDA marketing cessation of TVM in USA, their use nationwide was also discontinued or paused, thus leaving just a handful of companies still supplying TVM in fear of lawsuits and decreased demand. The Surelift System (Neomedic International, Spain) is marketed as a universal mesh, where it is applicable to be used for anterior, vault and posterior prolapse. The primary objective of this study is to determine the objective (anatomical) cure rates and subjective (functional) cure rate of POP treatment using the modified Surelift system. The secondary objective was to evaluate the quality of life (QoL) and lower urinary tract symptoms (LUTS) outcomes, sonographic outcomes as well as its surgical complications.
Study design, materials and methods
This is a descriptive retrospective study performed in a tertiary referral center. The patients who underwent prolapse surgery using Surelift® System from July 2018 to January 2020 were reviewed, after obtaining institutional review board approval. Patients with symptomatic advanced pelvic organ prolapse (POP-Q Stage III and Stage IV) were included. Exclusion criteria were patients with previous radical pelvic surgeries and prior mesh surgeries for prolapse.
Preoperative Assessment
Pre-operative evaluation followed institutional protocol comprising medical history, physical and pelvic examination, and multichannel urodynamic study (UDS) performed for all patients. Objective evaluation comprises pelvic examination using POP-Q measurement, 72-hour voiding diary, and multichannel UDS testing, including 1-hour pad test. Subjective evaluation performed through validated questionnaire including IIQ-7, UDI-6, POPDI-6, CRADI-8 and PISQ-12.
Surgical Procedure
The Surelift anterior repair mesh comprises of 6 arms, in which the 4 arms are passed through the obturator foramen after passing needles in an outside-in methods, while the 2 distal arms are to be fixed to the sacrospinous ligament (SSL). The author chooses to standardly modified the mesh by removing both the middle arm without compromising the integrity of the mesh.
All patients were followed up post-operatively at 1 week, 1 month, 3 months, 6 months, and annually following institution protocol. Multichannel UDS, 1-hour pad test, and validated subjective questionnaires was performed post-operatively at 6 months and annually. Specifically at 3 months follow up, 1 year and 3 years post-operatively, introital-perineal 2D ultrasound were performed on all patients. The pubic symphysis (PS) is taken as the fixed point and measurements were taken at rest and Valsalva. All measurement of the mesh and bladder neck distance is taken in millimeter (mm) from the midsagittal midline position13.
Outcome Measures
The primary outcome measures were the objective cure rate of POP, defined as anterior and apical prolapse of POP-Q < Stage 1, as well as the subjective cure rate determined based on patient answering NO to question 2 and 3 of POPDI-6 (heaviness or dullness in pelvic area and sensation of POP, respectively).
The secondary outcomes were QOL and LUTS, the presence of de novo or persistent USI (determined by postoperative UDS), as well as surgical complications. The subjective SUI was determined by a positive answer to question 3 of UDI-6.
Results
99 women underwent Surelift anterior system repair for POP-Q Stage ≥ III. Data was incomplete for 14 patients, and excluded from study. 85 patients were included in final analysis. The mean age was 66.6+8.3 years, with majority (94.1%) were postmenopausal. 69.4% (n=59) had vaginal hysterectomy, and half (n=43) had TOT performed. There were one (1.2%) bladder injury, which was repaired immediately and Foley catheter removed after 72hours. Patient had uneventful postoperative recovery. Median period of follow-up was 47.8+5.3 months, with a cross-sectional study period of 36 months taken as analysis point for all patients. (Table 1)
The overall objective and subjective cure rates at 3 years is 94.1%, and 91.8% respectively. This cure rates were found to be not much different when compared at the first year, in which overall objective cure rate was higher 97.6%, and subjective cure rates 94.1%. Good outcomes were seen in all 3 compartments in the first year, however the cure rates reduce slightly upon the third year: anterior compartment 98.8% and posterior compartment 94.1%. There is no difference seen in the apical compartment between the first and third year postoperative.
Four patients (4.7%) had vaginal mesh exposure. All were diagnosed between 48 hours and 2 months postoperatively. These patients underwent excision of the exposed mesh between the second and fourth month postoperatively in outpatient setting. None had persistent mesh exposure thereafter.
Occult or overt USI were seen in 56.5% (n=48) of patients preoperatively. Overall, USI rates showed significant improvement at first and 3 years (37.5%, 31.5% respectively). In patients with USI who opted to have concurrent MUS surgery (n=43/48, 89.6%), significant improvement seen at both first and 3 years (4.7%). The postoperative rate of de novo USI (objective) and SUI (subjective) at first and 3 years were found to persist in group without concomitant sling surgery, in which MUS were subsequently performed on one patient thereafter. Bladder outlet obstruction (BOO) was resolves in all except 2 (2/23, 8.7%) patients in the first year and 1 persisted at the third year (p<0.001). (Table 2)
All validated QOL questionnaires (UDI-6, IIQ-7, POPDI-6, CRADI-8, and PISQ-12 shows significant improvement in comparison of pre- and postoperatively with no significant differences between the first and third year.
Ultrasound measurement of mesh length, thickness, and distance of bladder neck to distal end of tape (D-BM) were evaluated post operatively. Mesh length was found to be elongated progressively in first and 3 years. Mesh thickness appears to increase in the first year, however resolution of thickness is seen at third year. The distance from bladder neck to distal end of the tape shows no statistical significant changes in measurement between 3 months and 3 years postoperative.
Interpretation of results
There are extremely limited data on long term outcomes of Surelift. What this study added is the modified surgical technique of Surelift system with 4-point fixation technique, that allows sufficient width of anterior and apical support to address paravaginal defects. This modification allows for intraoperative adjustability of mesh, ensuring a flat, tension-free mesh deployment without the need for excessive dissection. Included in this study is also ultrasonography study of the behavior of the mesh postoperatively within this short term.
Good 3-years objective and subjective outcomes were seen in this study. Whilst the support for both the anterior and apical compartment maintained over the study period, the statistical significance of deteriorating posterior compartment support as depicted in comparison may suggest progression of prolapse over time without mesh support. Nonetheless, the magnitude of progression clinically does not require any correction or repeat surgery nor did it had any effect on the quality of life.
Concluding message
The newer generation Surelift System is effective in the anatomical correction of advanced anterior and apical prolapse, with high objective and subjective cure rates, persevered, and demonstrates secured mesh placement, up to 3 years postoperatively. Complications are infrequent, mostly being related to mesh exposure, which can be managed effectively and uneventfully.