Six-year follow-up in patients with urinary stress incontinence treated with Altis® single-incision sling: a prospective single-center study

Abstract

Objetives: Single incision slings are the latest generation of suburethral bands that seek to minimize morbidity and major complications of transobturator bands. In short and medium term, their results in terms of success and safety are similar to transobturator and retropubic bands. Nevertheless, there is little data on their long-term outcomes. Our objective was to evaluate safety and efficacy of Altis® mini-sling during the short, medium and long-term follow-up. Methods: Prospective observational study in 67 women who underwent surgery with Altis® for a period of 6 years (2013-2019). The main variables evaluated were: total continence, objective cure and subjective cure (satisfaction). The secondary variables studied were: complications and number of pads used per day after surgery. Statistics: Student t-test or U-Mann-Whitney for quantitative variables, Chi-Square for categorical variables. Results: Objective cure rates were: 96.77%, 87.04%, 87.50%, 85.71%, 76.92% and 50% (from 1 to 6years), and total continence: 85.48%, 72.22%, 64.88%, 50%, 46.15% and 50% (from 1 to 6years). Degree of satisfaction was: 9, 8.2, 8.3, 7.7, 7.6 and 6.5 points (from 1 to 6years). 30 patients (44.78%) had some type of complication and the most common were: “de novo” urinary urgency (20.90%), recurrence of stress urinary incontinence (14.93%) and pain (5.97%). Conclusion: Altis® presents high rates of objective and subjective continence in short and medium-term (1-5years), during 6-year follow-up. It is safe and does not associate severe complications. We found a high percentage of “de novo” urgency and recurrence of stress urinary incontinence, especially after the fifth year.

Management of female stress urinary incontinence with single‐incision mini‐sling (Altis®): 36 month multicenter outcomes

“…15 Up to the 4-year mark, where the attrition rate was reasonable, negative CST rates ranged between 96.8% and 85.7% from years 1 to 4, respectively. 15 Two publications (same patient cohort) used 24-h Pad Weight Testing, with results of and 90.0% meeting the performance goal of 50% decrease and "dry" (pad weight ≤ 4 gm) measured at 77.2% and 81.1% at 12 and 24 months follow-up respectively. 11,12 Another study that defined cure as pad weight ≤ 8 grams was achieved in 72.0% at 36 months.…”

“…20 There were no cases of mesh exposure, extrusion, or erosion due to the study sling observed in the Altis 522 Study, which is consistent with the low event rates described in the literature (0.7−5.2%). [12][13][14][15][16][17][18][19] Interestingly, the first paper published on Altis had an extrusion rate of 3.5%. 12 In that IDE trial there could be no prior experience of the surgeons using Altis since all patients had to be enrolled in the trial.…”

“…16 Furthermore, observed adverse event rates in the Altis 522 Study are similar or better than published literature. Reported complications include urinary tract infections, 0.9−9.8% 12,13,15,17,18 ; dyspareunia, 0.9−11.7% 12,13,16,19 ; and urinary retention, 1.8−10.6%. 10,12,13,[17][18][19] In general, these complication rates were lower in this study, particularly for dyspareunia for both the Altis and Comparator groups.…”

“…Our results are consistent with published literature on Altis SIS. CST procedures were performed in six studies, with negative CST results ranging 50−92% 10–15 . Viruega‐Cuaresma et al reported negative CST of 50% at 6 years based on two patients 15 .…”

“…CST procedures were performed in six studies, with negative CST results ranging 50−92% 10–15 . Viruega‐Cuaresma et al reported negative CST of 50% at 6 years based on two patients 15 . Up to the 4‐year mark, where the attrition rate was reasonable, negative CST rates ranged between 96.8% and 85.7% from years 1 to 4, respectively 15 .…”