Discussion
bleeding, postoperative pain, incontinence, bladder and bowel perforation, TVT, gynecological incontinence, memory disorder, SUI, MUI
BLEEDING, INCONTINENCE, URINARY INCONTINENCE, COMPLICATIONS
This long-term follow-up study of a prospective RCT showed that MUS surgery, as a treatment for SUI and MUI with a predominant stress component, has a good long-term subjective outcome. Similar subjective outcomes were found for the TVT and TOT procedures. To the best of our knowledge, this is the first long-term follow-up study using a previous RCT study population with comparable study groups and to standardize the factors related to the success of the operation.This study showed good subjective outcomes after MUS surgery in a long-term follow-up. Preoperatively, most of our patients suffered from severe incontinence (UISS>8). According to the 3-month follow-up, the UISS was significantly lower than the preoperative score, showing good primary success of the MUS procedures. Even after the 16-year follow-up, the UISS remained at a significantly lower level than the preoperative score, showing good long-term success of MUS. Furthermore, no significant difference was found in the PGI-I score between the TVT and TOT groups 16 years after surgery. Dichotomizing the PGI-I score into good (1–3) and poor (4–7) outcomes, there were slightly more patients in the TOT group reporting poor outcomes than in the TVT group, although the difference was not statistically significant. However, the patients with poor subjective outcomes according to the PGI-I score had a higher age and BMI, which could explain the slight difference between the TVT and TOT groups. Our findings are comparable with those of previous studies, which showed that MUS surgery has good long-term effectiveness in the treatment of SUI [To our knowledge, there are only a limited number of studies comparing the outcomes of retropubic and transobturator MUS techniques. The present study showed no difference in the subjective outcomes between the TVT and TOT procedures in a long-term follow-up when the confounding factors related to operation success, such as the patients’ characteristics and the surgeons’ experience, were considered. We found that in a 16-year follow-up, the severity of urinary incontinence, pelvic floor function, and postoperative improvement according to validated questionnaire scores were similar in the TVT and TOT groups. These results are in accordance with those of several other studies demonstrating equal long-term effectiveness between TVT and TOT procedures [The TVT procedure was the first minimally invasive MUS operation to be used effectively to treat SUI. The TVT route can expose patients to rare but, nonetheless, severe complications (bladder and bowel perforation, severe bleeding), which can be avoided using the TOT route [Long-term follow-up with a high response rate (72%) and a prospective randomized controlled design are the strengths of this study. This study is the first long-term study to be based on a previous RCT with minimal differences in the baseline characteristics (i.e., a slightly higher BMI in the TOT group). Validated questionnaires were used to assess the subjective cure, which is the main focus of gynecological incontinence surgery. Furthermore, the procedures were performed by one experienced surgeon, reducing the bias of a learning curve effect on the clinical outcome. This study also has some limitations. The number of patients in the study was quite small, and the limited number of cases could underestimate the statistically significant differences between the study groups. Furthermore, despite the high response rate, missing data may lead to a slight bias, whereas nonresponders were older, they had more severe incontinence and the immediate success of MUS was lower, which may have had a slight effect on the evaluation of the long-term outcome. Although we were able to analyze the subjective cure rate using a validated questionnaire, the lack of assessment of postoperative pain and an objective cure rate can be considered limitations. Moreover, the PFDI-20 questionnaire is aimed at investigating pelvic floor problems, not at purely assessing difficulties in urinary incontinence. We did not have complete information about the patients’ general state of health, and the subjective symptom assessment could not have been completely reliable in all study cases, especially among the elderly and/or patients with memory disorder. Although we were able to standardize the experience of the surgeon, it makes the results less generalizable, and it is possible that the one surgeon favored or had more expertise in one method than in the other. Last, our data were limited in evaluating the need for re-operation and the number of complications related to different surgical methods.Midurethral sling surgery is a minimally invasive and effective treatment for SUI when conservative treatment does not provide sufficient symptom relief. Initially, the focus was on the TVT method, but complications after TVT led to the development of TOT methods. However, owing to a lack of evidence for their effectiveness and long-term follow-up data, there has been uncertainty about the superiority of one of these two methods over the other. Our prospective follow-up of an RCT shows that TVT and TOT procedures are equally effective in terms of the subjective cure rate in a long-term follow-up when the factors related to MUS surgery success are standardized. Despite the limited sample of women presented in this long-term follow up, this study provides insightful data that could also be useful in future meta-analyses. Further studies are needed in terms of complications and need for reoperations related to different MUS techniques. Considering these results, we recommend choosing the method in accordance with the surgeon’s best experience.