Adjustable mini‐sling compared with conventional mid‐urethral slings in women with urinary incontinence. A randomized controlled trial

Abstract

Introduction. The primary aim of this study was to compare the objective and subjective outcomes and short-term complication rates of an adjustable singleincision mini-sling (SIMS) vs. standard mid-urethral slings (SMUS). The secondary aim was to report pain perception and complications at the oneyear follow up. Material and methods. The study was designed as a multicenter prospective randomized trial where women were included from eight centers in Denmark, Norway and Sweden. The trial was registered at ClinicalTrials.gov: NCT01754558. A total of 305 women less than 60 years old with verified stress urinary incontinence were included. All women were randomized to SIMS (Ajust

Adjustable mini-sling compared with conventional mid-urethral slings in women with urinary incontinence: a 3-year follow-up of a randomized controlled trial

“…Data were recorded following inclusion. The follow-up conducted from inclusion up to 1 year is described in the study by Rudnicki et al [21].…”

“…The study was designed as a randomized trial and one-sided power analysis that was conducted before randomization showed that the inclusion of 131 women was required in each arm anticipating a cure rate of not less than 9% for Ajust® compared with SMUS (α = 0.05, β = 0.2) [21]. Data were analyzed using descriptive and analytical statistics.…”

“…However, most of the studies concerning Ajust® demonstrate a follow-up period of around 1–2 years, with the exception of one study analyzing 3-year results [20]. Considering the initial promising results of the Ajust® sling, Rudnicki et al published a randomized controlled trial in 2017, which was the first to compare Ajust® with SMUS other than TVT-O [21]. This study showed no significant difference in objective or subjective cure rates after 1 year and there was no difference observed in postoperative improvement or complication rates either.…”

Single-incision mini-sling for the treatment of female stress urinary incontinence: Is it actually inferior to transobturator vaginal tape and tension-free vaginal tape?

“…[ 4 ] Nevertheless, this procedure was is associated with more complications, prolonged hospital stay and a high rate of anterior vaginal wall prolapse. [ 5 ] Nowadays, Burch colposuspension is replaced by minimally invasive procedures using mesh sling, a new surgical technique with minimal surgical trauma access, performed under local anesthesia, that has been found to significantly improve the quality of life,[ 6 ] similarly to what has been found for native tissue repair[ 7 ] an and other techniques. [ 8 ] Several studies have shown that the transobturator procedure is associated with postoperative pain in the inner thigh, but it shows high percentage of cure rates (up to 90%), shorter operation time, less blood loss as compared to retropubic route.…”

“…[ 8 ] Several studies have shown that the transobturator procedure is associated with postoperative pain in the inner thigh, but it shows high percentage of cure rates (up to 90%), shorter operation time, less blood loss as compared to retropubic route. [ 5 ] The single-incision mini-sling (SIMS) was introduced in 2008 with the aim to further decrease potential complications from retropubic and transobturator approaches (such as bladder or bowel perforation and vessel injury). [ 9 ] There is no blind passage of the needle introducer through the retropubic space when inserting the tension-free vaginal tape (TVT) nor the passage of trocars through the obturator or adductor muscles when inserting the transobturator tape (TOT).…”