Hypothesis / aims of study
The prevalence of stress urinary incontinence (SUI) is about 5-69% (1), which constitutes a huge health problem with a negative impact on quality of woman’s life.
A randomized clinical trial (RCT) showed a complication rate after 36 months of the surgery with a single-incision slings (SIMS), that included 14.1% groin or thigh pain, a smaller rate in comparison to mid urethral sling (MUS) that was 14.9% (2).
This study aims to evaluate the success and postoperative complications rates and its time to onset, after a mean follow-up of 8 years from TOT Altis® surgery.
Study design, materials and methods
We conducted a retrospective observational study of patients with SUI treated with the SIMS TOT Altis® surgery between June 2015 and December 2018. Descriptive analysis of epidemiological and clinical variables. Multivariate analysis (Chi-square) between mesh exposure or incontinence recurrence and different qualitative independent variables (Obesity, dyspareunia, constipation, estrogen preoperative therapy, pelvic organ prolapse).
We considered surgery success an answer as “yes” when we asked patients during the follow-up if they had experienced SUI after the surgery (dry-patient).
Results
A total of 232 women underwent mini-slings TOT Altis® surgery with a mean follow-up of 94 months.
- Demographic data:
Average age among patients was 53.31 years, 14.7% (n=33) of the patients were obese. Stress Urinary Incontinence was present in 72% (n=167), while 28% (n=65) had mixed urinary incontinence (MUI).
71,6% (n=166) had at least one vaginal delivery. Constipation 31.8% (n=74). 41.8 % (n=97) women had menopause genitourinary syndrome, while 5,2% (n=12) were under preoperative oestrogen treatment. Dyspareunia was present in 26.7% (n= 62). Pelvic organ prolapse (POP) rate was 29.7% (n=69).
- Surgery outcomes:
The mean follow-up time after surgery was 94 months (range 66-99 months).
Postoperative complications were the following:
7.3% urinary tract infection (UTI; n=17), 3% acute urinary retention (AUR, n=7) while voiding dysfunction after surgery occurred in 2 patientes (0.86%). 9.5% (n=22) postoperative pain. The mesh exposure rate was 13.8% (n=32) with an onset average time of 13.87 months (range 1-62 months). SUI recurrence was 19.8% (n=46), and the onset average time was 7,75 months (range 1-60 months).
The surgery success rate was 80.2% (n=186).
Chi-square test showed a statistically significant association between SUI recurrence and vaginal delivery (p=0.041).
While mesh exposure had a statistically significant association with dyspareunia (p=0.012) as well as with pelvic organ prolapse (p=0.048).
Interpretation of results
After a mean follow-up of 94 months a surgical success rate of over 80% was reached. The most frequent complication was SUI recurrence (19.8%) during the first year after the surgery, while the second one was mesh exposure (13.8%), after the first year of the surgery.