Hypothesis / aims of study
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 five years of follow-up.
Study design, materials and methods
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 197 having a minimum follow-up of 5 years.
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.
After 2 years without complications and with adequate evolution, the patients were discharged from the Functional Urology Department.
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.
Between 2022 and 2023, a structured telephone survey was conducted with all patients who underwent surgery during the study period, analysing the presence of incontinence and urgency, the occurrence of complications and overall satisfaction with the procedure (table 1). Continence status was established using the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) and a subjective stress incontinence test. Satisfaction was assessed using the Personal Global Impression of Improvement scale (PGI-I). The development of complications secondary to the mesh over the years since implantation was also queried. Patients who required it were referred to the hospital.
Results
We analyzed 197 patients with a minimum follow-up of 2 years, with 155 patients being surveyed (21% loss to follow-up). The mean follow-up time in 2023 was 7.1 years (6.9 - 7.3), with a maximum follow-up of 10.3 years.
The mean age was 57.5 years (±12.7). Simultaneous anterior or anterior and apical prolapse correction was performed in 30 patients.
Preoperative urgency was present in 118 patients (60.2%) and 28 patients (14.3%) had previous anti-incontinence surgery. Mean age was 58 years (±12.7). Ninety-nine patients presented mixed incontinence (57%).
Continence rate was 92.4% at 2 years follow-up, with a significant decrease in ICIQ-SF from the start of follow-up. SUI correction was maintained over time, with 75.6% of patients surveyed in 2022-2023 having a negative stress test.
The evolution of the ICIQ-SF was analyzed and decreased by an average of 9.6 points (8.5-10.8). Although the overall value remained low, when analyzed according to the presence of OAB, the values for patients with pure SUI were much lower.
Patients' perception of improvement was also influenced by the presence of overactive bladder (OAB), being very high in patients with pure SUI (97.1%) and clearly lower in patients with OAB (75.3%).
No serious intraoperative complications were described. Mesh erosion was documented in 5 patients (3.22%). Ten patients required mesh removal (5.1%), due to recurrence of SUI (4 patients, retropubic sling placement), erosion (3 patients, 3bT2S1, 3bT1S1 and 3bT2S2), groin pain (1 patient, 6bT2S4) and urinary retention (1 patient, 4bT2S5). Another patient had an accidental section during another subsequent vaginal surgery.
High postvoiding residue was observed in two patients (4bT2S1). Urodynamic study was performed, and bladder outlet obstruction was demonstrated. Partial excision of the sling was performed.
Nine patients 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.
In 2022, 87% of patients (135/155) had no long-term complications. The most frequent complication was urinary tract infection (9.7%).
De novo OAB was described in 2.5% (2/78), 9.4% (7/74), 11% (8/73), 18.7% (12/64) and 38% (22/58) at 1, 6, 12, 24 months and at the time of the survey, respectively.
Interpretation of results
Single-incision slings have been proven to have high efficacy and good safety during follow-up (1).
This is the largest cohort reported to date of patients treated with this single incision sling (2). The persistence or occurrence of OAB influences long-term satisfaction rates and patients with mixed urinary incontinence should be warned about this, prior to surgery. Development of de novo OAB, in line with the ageing population, may diminish the perception of improvement in these patients.