Hypothesis / aims of study
Tension re-adjustable mid-urethral sling, ReMEEX sling system, is a device in which sling tension can be re-adjusted immediately postoperatively or at several months, even years after initial surgery. On the other hand, ReMEEX implantation may increase the number of foreign bodies and the probability of suprapubic wound infection. Our study assessed the efficacy and safety of implantation of ReMEEX system in female stress urinary incontinence (SUI) with detrusor underactivity (DU), recurrence, or intrinsic sphincter deficiency (ISD).
Study design, materials and methods
The study cohort included 303 female patients who underwent ReMEEX system positioning between March 2008 and May 2021. Patients were assessed before surgery by physical examination, urinalysis, free uroflow, stress test, 1-hour pad test, urodynamics and quality-of-life questionnaire. DU was defined when Qmax was ≤12 mL/sec and PdetQmax was ≤10 cmH2O during a pressure-flow study. Recurrence case was the failed previous surgery for genuine SUI. ISD was defined as ALPP <60 cm H2O or MUCP <20 cm H2O. Based on postoperative symptoms, patients were stratified into those who were cured (absence of subjective complaint of leakage and absence of objective leakage on the stress test), those who showed improvement (rare leakage subjectively, but satisfaction regardless of the stress test), and those who were failed (all other outcomes and use of any treatment for postoperative incontinence). Complications were evaluated with Clavien-Dindo system.
Results
There were insignificant differences among subgroups except mean follow-up duration (p<0.001). There were no significant differences among subgroups in post-void residual urine (p=0.209), IPSS QoL score (p=0.069), and total OABSS score (p=0.818) performed before surgery, at postoperative 1st year and 2nd year. Meanwhile, Qmax (p=0.002) and Total IPSS score (p=0.044) significantly differed among groups. At the final follow-up visit, 130 (42.9%) patients were cured, 149 (49.2%) were improved and 24 (7.9%) failed treatment. At a mean follow-up period of 34.4 (±31.5) months, 65 patients (21.5%) required sling tension re-adjustment (mean number: 1.2). Total complication rate (any grade) was 19.5% without complication ≥grade 4. Complications included voiding difficulty requiring catheterization (52, 17.2%), Wound problem (10, 3.3%), and severe leg pain (3, 1.0%).
Interpretation of results
Our findings add data on the safety of using the Remeex® readjustable sling with an acceptable number of complications compared with other existing studies. Our general complication rate (19.5%) is comparable to that of other series, ranging from 31.7% to 51.1%. Readjustment of the Remeex® system was performed in 21.5% of our patients, not inferior to others (15.6 - 42.9%).
There is no concensus regarding the exact tension needed for each patient undergoing an adjustable sling procedure. Nevertheless, surgeons performing ReMEEX should have extensive knowledge on proper sling implantation techniques to decrease the number of unexpected adverse outcomes. The greatest advantage of the ReMEEX is its readjustment capacity to achieve an ideal tension for each woman, reducing and even avoiding possible re-interventions. Our rate of readjustments (21.5%) is higher than others (7-10% during 11.7 - 60.6 months). Despite our higher rate of readjustment, we showed one patient was readjusted to keep continence 130 months after surgery revealing durability and safety of ReMEEX system.
Concluding message
The ReMEEX system resulted in a success rate of 92.1% at a mean follow-up of 34.4 months with a relatively low complication rate (19.5%) in female SUI with DU, reoperation, or ISD. The ReMEEX system also enabled postoperative re-adjustment of sling tension, as needed, up to 130 months after surgery. Our midterm outcomes are comparable with other series, with a low rate of complications. Well-designed, prospective studies with a careful preoperative assessment may result in better cure rates in these complicated SUI patients.