Urinary incontinence (UI) has been described as any complaint of involuntary leakage of urine. Stress urinary incontinence (SUI) is estimated to affect 13-46% of women. The most common surgeries performed worldwide for this condition are tension-free vaginal sling procedures, using either a transobturator (TOT) or retropubic approach (TVT).
The aim of this study is to report our results on the efficacy and safety of a novel adjustable single-incision sling (Altis® Coloplast, France) for the treatment of female SUI based on more than 12 months of follow-up.

Retrospective, nonrandomised, multicentre study.

Two-hundred twenty-three women (223) underwent sling placement in two tertiary hospitals in Spain from February 2012 to March 2018. Of these, we analyzed 174 having a minimum follow-up of 12 months. 

Data were collected from the clinical chart, clinical interview, and physical examination of the patients. Preoperative assessment was performed by cough stress test, urinalyses, and urodynamics (flowmetry or complete study). 
These data represent outcomes which were measured by a cough stress test, administration of the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and recording of complications following IUGA recommendations. Follow-up was performed at 1, 6, 12, 24, and 60 months postoperatively.
Success criteria were as follows:
-	Success: negative cough stress test;
-	Improvement: positive cough stress test with a lower ICIQ-SF index; and
-	Failure: positive cough stress test with the same or worse ICIQ-SF index.

Statistical analysis was performed using Stata 2.0.

We analyzed 174 patients with a minimum follow-up of 12 months. 
Mean age was 58 years (±12.7). Ninety-nine patients presented mixed incontinence (57%). 
Twenty-five patients underwent surgical intervention for pelvic organ prolapse (POP) at the same time (14%). Five patients presented a neurological illness and one patient had a previous reconstruction with a Studer neobladder.

Median follow-up was 35.4 months (12-70). Success was achieved in 115 patients (91%) two years postoperatively. During follow-up, five patients were reoperated for failure of the procedure, in which case the adjustable TVT procedure was carried out. After five years a follow-up, 89% of patients were dry (24 of 27 patients).

Twenty-five patients had been treated previously for SUI with different techniques (14%). All had resolution of SUI.
Ninety-nine patients presented mixed incontinence (57%). Ninety-one percent were cured of SUI after surgery and 66% were cured of urgency urinary incontinence (64 patients). Urgency decreased at one month in all patients, from 57% to 20% (p= 0.000). Previous urgency was the only risk factor associated with postoperative urgency.
There were some complications during follow-up. Two patients (1%) presented vaginal extrusion (3A T1 S1 and 3A T2 S1) and four (2%) developed limited vaginal hematoma (no IUGA). 
Three patients developed voiding disfunction (2%): one patient presented self-limited urinary retention and needed self-catheterization. High postvoiding residue was observed in two patients (4B T2 S1). Urodynamics were performed and bladder outlet obstruction was probed. Partial excision of the sling was performed.

Nine patients (5%) developed chronic groin pain (1Be T2 S3 and 8Bd T2 S3) and have received pharmacological and physical treatments. One patient required total sling removal for pain relief.

Chronic groin pain was more frequent in younger patients (50 ± 5.9 years with pain vs. 58 ± 12.8 years old without pain, p= 0.007).

Mesh complications were associated with pelvic organ prolapse (POP). Patients with POP accounted for 12% of mesh complications (3 patients of 25 POP) compared to 1% of patients without POP (2 patients of 150 no-POP, p= 0.022).

Decreasing ICIQ-SF index showed high statistical significance during follow-up (p< 0.001). Satisfaction and benefit were high.

This is the largest cohort reported to date of patients outfitted with this single incision sling (1,2).
This device has been proven to have high efficacy and good safety during follow-up (1,2). Proper placement of this device ensures the success of surgery, though placement through the internal obturator muscle must be performed with care, as this technique is associated with groin pain, especially in younger women.
Adjustment of the device makes it possible to select the correct tension of the mesh and guarantees better success than with other slings. The good long-term results reported and low rate of complications allow use of this device with confidence.
No data on resolution of mixed incontinence using this sling have been published previously. In this study, urgency decreased from 57% to 20% after surgery. We demonstrate that SUI surgery can cure urgency in 66% of case of mixed incontinence.

The Altis® Single incision sling is an efficacious and safe device for the treatment of SUI in females. Promising initial data have been confirmed during follow-up. Previous urgency and younger age are risk factors for developing postoperative urgency and chronic groin pain, respectively.

Kocjancic E, Tu LM, Erickson T, Gheiler E, Van Drie D. The Safety and Efficacy of a New Adjustable Single Incision Sling for Female Stress Urinary Incontinence. J Urol. 2014 Nov;192(5):1477-82. doi: 10.1016/j.juro.2014.05.101
Kocjancic E, Erickson T, Tu LM, Gheiler E, Van Drie D. Two-year outcomes for the Altis® adjustable single incision sling system for treatment of stress urinary incontinence. Neurourol Urodyn. 2017 Aug;36(6):1582-1587. doi: 10.1002/nau.23156.