Because of the common etiology, it is not surprising that almost half of the women with SUI underwent additional pelvic surgeries with incontinence surgeries (26, 27). Nevertheless, there is currently no consensus regarding the surgical treatment of SUI in patients who require concomitant surgical procedures for pelvic organ prolapse or benign uterine pathologies. In this study, we found that 88.4%, 87.5%, and 61.5% of women with SUI who had concurrent pelvic reconstructive surgery or hysterectomy were benefited from Burch colposuspension, TOT, and DynaMesh®- SIS minor mini-slings, respectively.
Mellier et al. found that the cure rate, which was considered as the complete absence of incontinence and was obtained via UDI-6 and IIQ-7 scores at a median of 17 months, were 73% in patients who underwent TOT (Monarch®) alone and 57% in patients who underwent TOT and other surgeries including VH, AC, PC, and vaginal vault suspension (28). They reported that sling extrusions and infections rates were similar in both of groups, but severe voiding dysfunction only occurred in the TOT-only group. Additionally, they concluded that TOT procedure can be safely applied with concomitant vaginal procedures (28). In the case series of Lo, 51 patients who had advanced pelvic prolapse and SUI were treated with TOT (Monarch®) and vaginal genital reconstructive surgery. In total, 86% of these patients were cured of incontinence at 12 months (29). Similarly, we found that the surgical success rate of TOT procedure was 87.5% at a median of 28 months in our study.
Burch colposuspension is an effective incontinence procedure, especially when the abdominal route is used for hysterectomy. However, Moon et al. compared the efficacies of Burch colposuspension and TOT in patients who underwent concomitant abdominal hysterectomy and abdominal sacrocolpopexy (ASC) and found that the cure rate was significantly higher in patients who underwent TOT with ASC than patients who underwent Burch colposuspension with ASC (69% and 98%, respectively) (30). The authors speculated that extensive traction on the bladder neck made by ASC mesh and Burch colposuspension could be the reason of the failures and de novo urgency. On the contrary, little or no effect of Burch colposuspension on postoperative failures, de novo overactive bladder, or voiding dysfunction was demonstrated in a recent Cochrane review (31). In our study, four out of 43 patients underwent Burch colposuspension for SUI with RFC for vaginal vault suspension, and surgical success was obtained in three out of four patients at 16 months, which was coherent with the surgical success rate of Burch colposuspension group.
Although SIS procedure could be performed with concomitant pelvic reconstructive surgery, data is scarce. Most of the studies that reported results of SIS procedure in patients with SUI excluded the patients with pelvic prolapse (16, 18, 32). Fernandez-Gonzalez et al. included patients with pelvic prolapse in their study, which compared SIS (Contasure needless®) with TOT (Monarch®) in the treatment of SUI. They found that Contasure needless® was not inferior to Monarch® (15). However, they did not separately analyze the surgical outcomes of patients with pelvic prolapse as a subgroup. We performed SIS procedure with DynaMesh® minor after completing the reconstructive surgery. To our knowledge, this is the first study that reports the surgical outcomes of SIS and compares three different procedures to treat SUI in patients who underwent concomitant pelvic surgeries.
Most of the early studies revealed that SIS (TVT Secur® was the largest sample) procedure had a higher incontinence rate and a higher chance of requiring repeated incontinence surgery than the TOT procedure (33, 34). Because of these medicolegal issues and inferior results of early trials, many SIS procedures were withdrawn from the hospital settings. Nevertheless, SUI procedures with newer SIS are promising. A randomized controlled study that compared SIS (Contasure-needleless®) with TOT (Contasure-KIM®) found that both procedures were comparable in terms of the objective/subjective cure and failure rates (16). In their randomized trial, Sivaslioglu et al. demonstrated better results with Tissue Fixation mini-sling procedure than TOT procedure in patients with urodynamically proven SUI (17). Yildiz et al. reported high success rates with Ophira mini-sling system at a follow-up of three years. They reported that the objective cure and failure rates were 83% and 9.8%, respectively (32). Moreover, Gambini-Ricapa et al. published high urodynamically proven cure rate after endopelvic free anchor mini-sling procedures at long follow-up and suggested that the success of the mini-sling technique was due to retropubic insertion route of sling to endopelvic fascia and pelvic diaphragm (18).
Contrary to the above studies, we found inferior objective cure and surgical success rates and higher failure rates in the SIS (DynaMesh® SIS minor) group than both Burch and TOT groups in our study. Inferiority was not observed between Burch and TOT groups. However, we recommend that results of our study need a careful interpretation. First, the material of the SIS was PVDF which is a non-absorbable, fluoropolymer monofilament, and it is different from the above-mentioned studies (that most commonly used polypropylene ). There is a paucity of data in literature regarding the use of PVDF slings in urinary incontinence procedures. While Padilla-Fernandez et al. reported less tolerance and less success rates of PVDF slings in TOT procedures (35), Sabadell et al. demonstrated similar efficacy and safety of PVDF slings with polypropylene slings (36). Currently, there are no studies that compare PVDF with polypropylene SIS. Second, Nambiar et al. concluded that the fixation mechanism of SIS was crucial, and poor performance of the withdrawn SIS might due to the lack of specific fixation systems (34). DynaMesh® SIS minor is a short sling that has self-attaching surface and was used without the need of any additional fixation device. Third, on December 2018, The Independent Medicines and Medical Devices Safety Review published that FEG Textiltechnik would be globally removing DynaMesh® SIS minor in the near future. Importantly, the reason to remove the product was not affected by an undesired clinical result and would not be carried out under the scope of a Field Safety Corrective Action (37). This action of FEG Textiltechnik will limit the further comparative studies. Third, we believe that all of the concomitant surgeries (hysterectomy either abdominal or vaginal, AC or Apical Suspension surgeries) could affect the success of the incontinence surgeries due to change in anatomy and by affecting pelvic support and continence. But we are aware of the concomitant pelvic surgeries had a broad spectrum among the three groups, which could invoke bias in the interpretation of results and complications. Hysterectomy rates were also not comparable among the groups (90.9%, 40.42%, and 33.33% in Burch, TOT, and SIS groups, respectively). However, vaginal concomitant procedures and approaches were more common in TOT and SIS groups. We have to mention that, because of PC is not an operation that can affect the results of incontinence procedures in our study, it was not performed as a single concomitant procedure. Instead, all PC procedures were performed with VH and AC.
Recently, the National Institute for Health Research of UK published ESTHER systematic review to evaluate the clinical effectiveness, safety, and cost effectiveness of surgical treatments of SUI (38). Their study reported that the cure rates at 12 months were 89.1%, 76.7%, 64.1%, and 39.8% for TVT, TOT, Burch colposuspension, and SIS, respectively. The need for repeat surgeries was higher in the TOT group than in the TVT (18.3% vs 0.5%) group and as well as higher in the SIS group than in the TOT (5.1% vs 2.9%) group. Although there was considerable uncertainty around the estimation of effects, voiding difficulties were higher in the patients who had Burch colposuspension than in patients who had TOT (OR: 1.96), and higher in patients who had TOT than in patients who had SIS (OR: between 0.34 and 0.93). While comparing the sling extrusion rates, similar results were obtained for a short term between SIS and TOT (4.8% vs 3.7%), but long-term results favored TOT again with uncertainty (OR: 2.43–5.02). The results of our study also showed that the voiding dysfunction rate was similar among the three groups, and the sling extrusion was higher in the SIS group than in the TOT group during long term. High rates of mesh extrusion in SIS might due to patient-related risk factors, that is, all patients who had mesh extrusion in the SIS group were in menopause, were grand multipara (parity ≥5), or had a possible inferior tolerance of PVDF sling.
Another conflicting issue is the uncertainty about the optimum predictor of successful treatment. Despite the ease of assessment and objectivity of negative stress test, patients’ subjective impressions regarding cure and improvement might be more important. According to this observation, some studies only used validated questionnaires or women’s self-reports to assess the cure rates (28, 38). Majority of studies demonstrated both women’s subjective cure and improvement by the quality of life questionnaires or simply examined satisfaction rate and objective cure by negative stress test (6, 15-18, 32, 39-41). On the contrary, Lo preferred to only report objective cure rate and results of urodynamic investigations (29). In our opinion, patients’ subjective impressions of cure and improvement, objective cure that defines negative stress test, and patient’s quality of life assessments with validated questionnaires are crucial and should be evaluated together.
Furthermore, the worsening of urge symptoms or persistent urgency might deteriorate patient’s quality of life, even when they are objectively cured. Domingo et al. concluded that mixed incontinence was not improved which was assessed by the quality of life questionnaires after TOT procedure and the main reason was patients’ worsening urge symptoms (39). Likewise, we found that OAB-V8 scores were lower in patients with surgical success than in patients with failure, and the rate of overactive bladder after surgery was higher in the SIS group, which was also associated with the lowest surgical success rate.
The strengths of our study are as follows: we compared Burch colposuspension, TOT, and SIS procedures to treat SUI in patients who underwent concomitant pelvic surgeries for the first time. Our study had relatively longer follow-up periods, and we used validated questionnaires to evaluate patients’ quality of life and also determined all objective and subjective cure, improvement, failure, and surgical success rates.
Despite the insights provided by our study, it is not free from limitations. We did not obtain the quality of life assessments before surgery. The study group includes all the patients with pure SUI or stress-predominant mixed urinary incontinence. This inclusion criterion might introduce bias during the evaluation of patient’s quality of life in terms of urgency symptoms. The concomitant pelvic surgeries belonged to a wide spectrum. We could not perform urodynamic studies; therefore, we could not exclude the patients with intrinsic sphincter deficiency, which could also serve as a possible bias.