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A randomized controlled trial comparing three single-incision minislings for stress urinary incontinence
Stefano Palomba1, Angela Falbo, Rosamaria Oppedisano
1Obstetrics and Gynecology Unit, Department of Obstetrics, Gynecology and Pediatrics, Azienda Ospedaliera "Santa Maria Nuova" - Istituto di Ricovero e Cura a Carattere Scientifico of Reggio Emilia, Reggio Emilia, Italy, stefanopalomba@tin.it.
This study found no significant difference in long-term urinary incontinence cure rates among three different single-incision minislings (SIMS) kits. The efficacy of these surgical treatments for female urinary incontinence was comparable across all tested devices.
Area of Science:
- Urology
- Gynecology
- Surgical Innovation
Background:
- Single-incision minislings (SIMS) are used for female urinary incontinence (UI).
- Existing efficacy data for SIMS show significant heterogeneity.
- The comparative long-term outcomes of different SIMS vaginal kits require investigation.
Purpose of the Study:
- To evaluate and compare the long-term efficacy of three distinct SIMS vaginal kits.
- To test the hypothesis that different SIMS kits yield varying long-term outcomes for UI treatment.
Main Methods:
- A multicenter randomized clinical trial involving 120 women with stress or mixed UI.
- Patients were treated with one of three SIMS: Ajust, MiniArc, or TVT Secur System.
- Follow-up was at least 24 months, assessing subjective cure rates, total failure, and reoperation rates.
Main Results:
- No statistically significant differences were observed in subjective cure rates (52.5%–65.0%) among the three SIMS groups.
- Total failure rates were also comparable across the groups (55.0%–67.5%).
- The proportion of patients requiring reoperation for UI did not differ significantly between the tested SIMS kits.
Conclusions:
- The long-term efficacy of single-incision minislings for female urinary incontinence is consistent across the evaluated vaginal kits.
- This suggests that the choice of vaginal kit may not significantly impact long-term UI treatment outcomes.
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