Single‐incision mini‐sling (
SIMS
) under local anesthesia for stress urinary incontinence: A single‐center prospective cohort study—12 months of follow‐up
Sofia Tsiapakidou, Iakovos Theodoulidis, Grigoris Grimbizis, Themistoklis Mikos Abstract
Objective
Stress urinary incontinence (SUI) is a prevalent and costly condition, with an estimated lifetime risk of surgery reaching 20% by the age of 80 years. Single‐incision mini‐slings (SIMS) represent the latest advancement in midurethral sling technology, offering a minimally invasive alternative to traditional retropubic and transobturator tapes (TOT). Studies indicate comparable subjective and objective cure rates between SIMS and TOT, with potential advantages in postmenopausal women owing to earlier mobilization and reduced morbidity. The study aimed to evaluate the efficacy and safety of SIMS under local anesthesia in the management of SUI.
Methods
A prospective cohort study was conducted in a tertiary academic urogynecology unit from December 2019 to December 2024. Consecutive patients meeting the inclusion criteria were enrolled following a standardized diagnostic and treatment protocol. Informed consent was obtained, and ethical approval was granted by the institutional review board. All patients underwent SIMS placement (Altis©, Coloplast) performed by two experienced urogynecologists under local anesthesia. Sling tensioning was performed via a standardized cough stress test at bladder volumes equal to normal voiding volume, as per pre‐operative urodynamics. Patients were followed for 3 weeks and 12 months post‐surgery. Data analysis was conducted using Microsoft Excel. Descriptive statistics were applied, and paired t ‐tests compared pre‐ and post‐operative results. Statistical significance was set at P < 0.05.
Results
A total of 124 women underwent SIMS for SUI, with a mean age of 63.8 ± 11.1 years and a body mass index (BMI, calculated as weight in kilograms divided by the square of height in meters) of 29.0 ± 4.3. Among them, 21.8% had severe and 78.2% had moderate SUI, while 30.6% presented with mixed urinary incontinence (MUI). Pre‐operatively, mean International Consultation on Incontinence Questionnaire (ICIQ) Urinary Incontinence Short Form (ICIQ‐UI‐SF) and Female Lower Urinary Tract Symptoms (ICIQ‐FLUTS) scores were 14.3 ± 2.4 and 19.0 ± 6.0, respectively. All surgeries were performed in an ambulatory setting, with 95.2% discharged the same day. The mean surgical time was 31.5 ± 8.0 min, and peri‐operative pain was 2.8 ± 1.8/10. At discharge, all but one patient had a negative stress test, and 99.2% would recommend the procedure. At 12 months, the composite outcome was successful for 103 (83.1%) patients, with an objective cure rate of 94.3% and a subjective cure rate of 83.1%. A clinically important difference in ICIQ‐FLUTS was observed in 92.7% of cases. Patient Global Impression of Improvement (PGI‐I, scores 1 or 2) was reported by 93.5%, and Patient Global Impression of Severity (PGI‐S, score 1) was reported by 83.9%. There were no cases of bladder perforation, major bleeding, mesh erosion, or reoperation.
Conclusion
The present study evaluates SIMS under local anesthesia as a minimally invasive and effective treatment for SUI, highlighting its potential benefits in post‐operative recovery and resource optimization. The findings contribute to the ongoing advancements in SUI management, particularly in addressing modern healthcare challenges.