Abstract
Introduction and hypothesisThe aim of this study was to compare the long-term subjective outcomes of an adjustable single-incision sling (Ajust®) vs standard mid-urethral slings (SMUS) for the treatment of women with stress urinary incontinence.MethodsThis study was designed as a multicenter prospective randomized trial. Women under 60 years old with objectively verified stress urinary incontinence were included from seven centers in three countries. Women with mixed urinary incontinence were also included. Randomization was held in blocks for operation with either Ajust® or SMUS. Women analyzed at 1-year follow-up received the International Consultation on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF), International Consultation on Incontinence Questionnaire Overactive Bladder, Pelvic Organ Prolapse/Urinary Incontinence/Sexual Function Questionnaire-12, Patient Global Impression of Severity, and Patient Global Impression of Improvement questionnaires, together with a bladder diary to fill out at least 3 years after the procedure. The main outcome evaluated was the subjective cure rate as reported through the ICIQ-UI-SF questionnaire at 3 years.ResultsIn total, 205 women participated in the 3-year follow-up: 107 in the Ajust® and 98 in the SMUS group. No significant difference was observed between the groups regarding subjective cure rate (50.9% vs 51.5%, p = 0.909) or dyspareunia. Both groups demonstrated similar postoperative perception of improvement in addition to reduced urgency and urge urinary incontinence. The postoperative improvement remained at the same level after 3 years as it was at 1-year follow-up for both Ajust® and SMUS.ConclusionsAjust® appears to be equally effective and safe as SMUS with regard to long-term follow-up of patient-reported outcomes.
Highlights
Introduction and hypothesisThe aim of this study was to compare the long-term subjective outcomes of an adjustable singleincision sling (Ajust®) vs standard mid-urethral slings (SMUS) for the treatment of women with stress urinary incontinence
Single-incision mid-urethral slings (SIMS), or mini-slings, have been introduced over the past few years to minimize the surgical procedure and operation time and decrease the number of complications associated with surgery for the treatment of stress urinary incontinence (SUI)
279 women from the seven centers in Sweden, Denmark, and Norway that participated in the 3-year followup were initially randomized between Ajust® and SMUS
Summary
Introduction and hypothesisThe aim of this study was to compare the long-term subjective outcomes of an adjustable singleincision sling (Ajust®) vs standard mid-urethral slings (SMUS) for the treatment of women with stress urinary incontinence. The TVTSecur has consistently demonstrated inferior results compared with standard mid-urethral slings (SMUS) and has been withdrawn from the market [2, 3]. These findings indicate the importance of the fixation system associated with each sling, as this aspect is suggested to be the main reason for the failure of the TVT-Secur [1]. Long-term follow-up research is needed before introducing a new device into clinical practice. Such data concerning the long-term efficacy and safety of SIMS has, to our knowledge, not yet been published
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