Hypothesis / aims of study
The management of stress urinary incontinence includes conservative and surgical treatments, the former being the initial treatment. In the surgical field, suburethral sling placement has been the Gold-Standard of urinary incontinence surgery in numerous international guidelines (1,2).
There are different suburethral sling procedures. The most frequently used is TVT-O (3), for its simplicity in placement, high efficiency and lower complication rate.
The aim of the present study was to assess the outcome of suburethral sling procedure for SUI carried out at a single teriatry hospital from 2012 to 2018. Secondly, to assess patient demographic characteristics, surgical outcome over time, complications and patient satisfaction.
Study design, materials and methods
Retrospective observational study carried out in the Pelvic Floor Unit of a teriatry hospital where all suburethral sling procedures, TVT-O and TVT, carried out during the study period were included.
A total of 924 patients were initially included however 685 were excluded due to concomitant surgery (mainly prolapse surgery) and another 4 due to incomplete data leaving 239 for analysis.
The variables collected were age, BMI, parity, year of surgery and days of hospital admission, menopausal status, the presence of concomitant prolapse, previous vaginal surgeries, treatment for UI at the time of surgery, treatment with estrogen, mesh type, intraoperative and early and late post-operative complications, reinterventions, and the degree of patient satisfaction, continence and prolapse at the first follow-up visit.
Statistical analysis was performed using the Spearman test for quantitative variables and Chi-square test and Fischer's exact test for binary variables. Statistical significance was considered with a p<0.05.
The mean age of the total of 239 patients included was 50 years (SD 8.2, 33-76), and their mean BMI was 27.24 (SD 4.2, range 17-48). Mean parity was 2 (SD 1, range 0-5) and mean days of hospital admission were 0.3% (SD 0.86, 0-6).
Of the total sling procedures performed, 94.1% (225) were TVT-O and 4.6% (11) were TVT. The number of sling procedures performed initially increased during the first years of the study period. In 2015, 22.2% (53 slings) were carried out, the highest proportion of sling procedures over the years of the study period. Subsequently, a gradual decrease was observed, where in 2018 a total of 7.9% (19) of the total sling procedures were performed. The indication of all TVT procedures performed were due to previous TVT-O failure.
40.6% (97 patients) of patients did not receive any prior treatment for urinary incontinence, where sling placement was the first line treatment. Those that received previous treatment, Mirabegron 30 mg per day was the most frequent. On the other hand, 80% of patients were prescribed local estrogen therapy months prior to surgery.
Regarding menopause and prolapse at the time of surgery, 39.7% of the patients were menopausal, and 65% did not have significant pelvic organ prolapse. Anterior compartment prolapse was the most frequent prolapse among patients. More than 90% had no previous surgeries.
Intraoperative and early postoperative complications were found in 34 (14.2%) patients: 12 UTIs, 12 patients had an acute urinary retention that resolved with self-catheterization and consequently prolonged hospital stay by one day, 5 vaginal perforations, and 5 bladder perforations. The vaginal perforations were treated in the same surgical procedure and evolved favorably, except for one case where an extrusion occurred and the sling had to be removed. Regarding bladder perforations, all were resolved in the same surgical procedure with sling removal and new sling placement. The comparative analysis between these complications and the type of sling will be discussed below.
Of the total surgeries performed, 90.8% (217) had no subsequent complication. There were 13 (5.4%) cases of pain in relation to the sling placement, and 9 (3.8%) cases of tape extrusion, 7 after TVT-O and 2 after TVT. Of these 9 cases, 4 required reoperation to remove the mesh, and 3 of them relapsed and underwent new surgery for TVT insertion.
The satisfaction rate was in 90% (215) of patients satisfied or very satisfied, compared to 9.6% (23) of patients who were not satisfied. One patient was lost to follow-up.
Finally, the degree of continence at the first follow-up visit after surgery was 86.6%.
Interpretation of results
The type of sling placed was compared with the degree of subsequent satisfaction, finding 90.6% satisfaction with the TVT-O vs 82% with the TVT, not finding statistically significant differences.
When satisfaction was analyzed according to the year of surgery, there was a gradual increase since 2012, which was 81.5%, until 2018, which was 94.7%. In addition, in 2016 100% satisfaction was found for all patients.
No statistically significant differences were found when the degree of satisfaction was related to menopausal status, previous vaginal surgeries or estrogen therapy.
The dissatisfaction after the surgery was significantly related to the pain in relation to the mesh, extrusion, persistence of incontinence, and postoperative urgency and urge incontinece. No statistically significant relationship was found between intraoperative complications and the degree of posterior satisfaction of the patients.
Pain due to the tape was found in 13, 12 were after the placement of a TVT-O and the remaining case was after the placement of a TVT. In addition, a multivariate analysis was performed analyzing the pain in relation to the degree of satisfaction and the type of mesh finding that 4 patients were not satisfied due to pain, all of them after TVT-O placement. Of these 4 cases, 2 patients persisted with pain causing limitation of their mobilization, and they required rehabilitation.
In relation to the intraoperative complications and mesh type, it was found that the 5 vaginal perforations were after TVT-O placement, and of the 5 bladder perforations, 4 were after TVT-O and 1 after TVT. This increased number of complications after TVT-O could be attributed to the higher proportion of TVT-O procedures.
No statistically significant differences were found between the degree of patient satisfaction and age, BMI or days of admission.
SUI is a prevalent condition, with a major impact on patient’s quality of life and consequently, has a great impact on our society.
The study carried out is related to the controversy arising on the safety of transvaginal polypropylene mesh in urogynecological surgery, which has called into question its use in pelvic organ prolapse surgery and subsequently its use and safety for the Urinary incontinence surgery.
In our series, the treatment of SUI with suburethral slings is an effective alternative, always taking into account patient characteristics and the training of the professionals who perform this type of surgery.
In addition, as in the literature, our series presents a higher number of complications due to pain in the TVT-O group compared with TVT.
According to our results, given the high satisfaction rate, it seems reasonable to continue using tension-free meshes, always following strict selection criteria in well-studied patients who are aware of the possible complications of the procedure.
Finally, the different scientific societies at the moment recommend that mesh surgery should only be carried out by accredited surgeons. In our series, the sling procedures were performed in more than 85% of the cases by two expert surgeons, which is one of the factors that ensures good results, according to the literature and current recommendations.