Single-Incision Mini-Slings for Stress Urinary Incontinence in Women: 5 years of follow up

gentile b1, Giulianelli r1, albanesi l1, puccini f1, d'ascenzo r1, ghahhari j1

Research Type

Clinical

Abstract Category

Female Stress Urinary Incontinence (SUI)

Abstract 823
Open Discussion ePosters
Scientific Open Discussion Session 109
Friday 25th October 2024
15:35 - 15:40 (ePoster Station 4)
Exhibition Hall
Incontinence Female Retrospective Study
1. Ospedale Regina Apostolorum
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Links

Poster

Abstract

Hypothesis / aims of study
Objective The aim of the study was to report the extended long-term results of the use of single-incision mini-sling (SIMS), in women with urodynamic clinical stress or mixed urinary incontinence in terms of improved continence status, quality of life or adverse events.
Background: Urinary incontinence has been shown to affect up to 50% of women. Studies have shown that up to 80% of these women have an element of stress urinary incontinence. Colposuspension and now mid-urethral slings have been shown to be effective in treating patients with stress incontinence. However, associated adverse events include bladder and bowel injury, groin pain and haematoma formationTreatment for female stress urinary incontinence (SUI) has progressed rapidly over the past ten years in the search for less invasive methods to treat this disease.
Until recently, synthetic midurethral slings (made of mesh or tape) were the standard surgical treatment worldwide for female stress urinary incontinence, if conservative management failed. The definition of a single-incision sling is "a sling that does not involve either a retropubic or transobturator passage of the tape or trocar and involves only a single vaginal incision (i.e. no exit wounds in the groin or lower abdomen)."Data confirming the long-term effectiveness of newer adiustable single-incision mini-slings is limited
Study design, materials and methods
We performed a  Altis® Single Incision Sling (SIS)among women during 5 years of follow-up. Effectiveness endpoints included objective dryness, negative CST, adverse events, and revision/resurgery through 60 months. The primary effectiveness endpoint was reduction from baseline in 24-h pad weight of ≥50% at 6 months, as requested by the FDA. Primary safety endpoint was rate of related serious adverse events (SAE) through 60 months. We subjected 60 women to single-incision adjustable mini-sling (Altis) surgery for stress incontinence. Enrolled women were evaluated by Patient Global Impression of Severity (PGI-S), Incontinence Impact Questionnaire (IIQ-7), and Incontinence Questionnaire-Urinary Incontinence (ICIQ-UI) Short Form and data about diagnosis, procedures, complications, reoperations, postoperative results, and satisfaction with procedure were recorded. Furthermore, all women underwent an invasive urodynamic examination before surgery, after 6 months and at three years.
Results
At 12 months, success was reported in 87 % patients. At the 36-month follow-up, success was reported in 81% of patients. Over the 36-month follow-up period, the we haven’t percentage of patients with tape or mesh exposure , and the percentage who underwent further surgery for stress urinary incontinence was 1.2%,. The  respect to quality of life and sexual function were good. We had only one patient with a drop in Hb of approximately 7 points (from 13.5 to 7.4), with a large muscular hematoma that extended along the vaginal wall up to the abdomen
The most surprising thing is that the success of this intervention remained high after 5 years (75.3 %).
Interpretation of results
The results were non inferior to standard midurethral slings and the percentage of patients reporting success remained good after 5 years, with a low operating time, a lower complication rate as reported in the literature.
Concluding message
The mini-sling was associated with short operative time (about 15 minutes) .The adiustable Single-incision mini-slings is currently the best compromise in terms of effectiveness alond complications if the choice had to be among the mini-sling in the treatment of stress urinary incontinence.
Disclosures
Funding none Clinical Trial Yes Public Registry No RCT No Subjects Human Ethics not Req'd It's a common surgery in women Helsinki Yes Informed Consent Yes
04/05/2025 20:03:27