Study design, materials and methods
Informed consent was obtained from all patients prior to their inclusion in the study and ethical approval was granted by the local ethics committee. All patients have informed about a transobturator approach to mid-urethral sling placement with autologous rectus fascia. This was a prospective randomised controlled study of female patients with SUI. Fifty-one patients who underwent transobturator sling placement using synthetic mesh (n: 25) or autologous rectus fascia (n: 26) were included in the study between January 2017 and December 2018. The clinicopathologic characteristics of the patients were age, body mass index (BMI), smoking, type of incontinence (stres or mix), previous pelvic surgery (Transobturator tape, transvaginal tape, pelvic organ prolapse surgery, hysterectomy, ceserean section, etc), parity, 24-hour pad test (mild, moderate or severe), perioperative and postoperative complications. All complications were evaluated using the Clavien-Dindo classification.
All patients were assessed pre-operatively with a detailed medical history and physical exam, urinalysis, urine culture, 24-hour pad weight, post-void residual measured by ultrasound. Outcomes in terms of continence and quality of life were measured by International Consultation on Incontinence Questionnaire-Short form (ICIQ-SF) and Urinary Incontinence Quality of Life (QoL) before the operation and at 1-year follow-up and Treatment Benefit Scale (TBS) were assessed at 1 year after operation.
Sealed opaque envelope method was used for randomization. The sample size was at least 20 patients per group to detect a power of 80% at 0.95 confidence interval and expected a mean reduction in the ICIQ-SF scores of 50% between before and after the treatment. All procedures were performed by a single experienced surgeon. All outcomes were determined by a single independent investigator blinded to the groups.
The data analysis was performed by using SPSS for Windows, version 11.5 (SPSS Inc., Chicago, IL, United States). Kolmogorov-Smirnov and P-P Plot tests were used to verify the normality of the distribution of continuous variables. Descriptive statistics for variables with a non-normal distribution and categorical variables were shown as median (min-max) and the number of cases and (%), respectively. Mann Whitney U test was used for the intergroup analysis of continuous variables. Categorical variables were analyzed with Chi square test. The differences between preoperative and postoperative values (ICIQ-SF and QoL) in all groups were assessed by Wilcoxon Signed Rank Test. p<0.05 was considered as statistically significant.
Out of 51 patients, 44 completed the study period. Twenty-one (47,7%) patients who underwent a transobturator sling placement using autologous rectus fascia (Group I) were compared with 23 (52,2%) who had synthetic mesh (Group II) at 1 year after operation (Table 1). Four (8%) patients in Group I and 3 (6%) were dropped out before completing the study. There were no statistically differecences between two groups in terms of BMI, smoking, existence of comorbidity, parity, history of pelvic surgery, type of incontinence (p>0.05, for all). One patients (4,7%) in Group I had a hematoma under insicision site at suprapubic region, one (4,7%) experienced short term (2 weeks) urinary retention and one (4,7%) suffered transient discomfort due to prolen sutures at inner thigh. No severe (Clavien III-V) complications were seen any patients in two groups. Compared to preoperative scores of ICIQ-SF and QoL at 1-year follow-up period, the patients in Group I showed significant improvement (p=0.001). There were no significant differences between Group I and II in terms of ICIQ-SF, QoL and TBS (p>0.05, for all). The operation time of Group I was higher compared to Group II. (45 vs. 30 min, respectively; p=0.01).
Interpretation of results
The main advantage of transobturator urethral sling placement with autologous abdominal rectus fascia is to minimize the risk of urethral or vaginal erosion because of causing minimal inflammatory and foreign body reaction. The main disadvantage of this novel surgical technique includes a longer operation time due to fascia harvesting and repositioning of the patient. Also, this addition procedure can cause some morbidities such as bleeding and infection at harvesting site.
Our findings reported that transobturator urethral sling placement with autologous abdominal rectus fascia had excellent long-term results. In additon, this study showed that this novel surgical technique is as effective, safe and feasible as the other transobturator approach.