One Year Outcome Using the Ajust System for Treatment of Urinary Stress Incontinence
Condition: Urinary Stress Incontinence
MeSH terms: Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      During the last decade numerous new procedures have been presented regarding surgical
      treatment of urinary stress incontinence (1,2). Development of the midurethral tape procedure
      (TVT) changed the surgical procedure dramatically both regarding the extent of the surgical
      procedure and also decreased the morbidity remarkably. The success rate of the TVT procedure
      has been proven to be high (1,2 ). However, the development of the TOT/TVT-O procedures
      disclosed a new fixation point and further decreased the risk of bladder injury (1,2). Since
      the introduction of trans-obturator slings several mini-slings have been introduced in order
      to reduce the need of perforation of the skin and muscles (3,4,5). Although some systems seem
      promising (5) others have disclosed a long learning curve, pain problems following the
      procedure and lower success rates, compared to the traditional sling procedures. None of
      these mini-slings have been adjustable.

      Recently the Ajust system for treatment of stress urinary incontinence was introduced. The
      system is a single incision sling procedure and consists of an adjustable Polypropylene mesh
      sling with self fixation anchors (6). In a feasibility study (6), the 6 months objective cure
      rate was 82%, but there is a lack of information regarding adverse events and durability of
      treatment success. Our preliminary experiences suggest, that the procedure has a rapid
      learning curve, low pain scores postoperatively and a 94% cure rate at 3 months follow-up
      (personal observation). Recently, several abstracts have indicated that the cure rate
      obtained by Ajust is comparable to TVT or TVT-O (10-12).

      The purpose of the present study is (primary outcome):

      To test the hypothesis that the Ajust and TVT, TVT-O and TOT, respectively are equal
      regarding subjective cure rate (cure is defined as subjectively not incontinent at all), i.e.
      the study is designed as a non-inferiority study. The study is performed as a randomised
      controlled trial without blinding. The study is powered to detect a 9% difference between the
      two groups. The subjective cure rate is based on ICIQ measurement

      Secondary outcome:

        -  To test the hypothesis that Ajust is associated with a significantly lower postoperative
           pain perception.

        -  To test the hypothesis that antibiotic treatment is not necessary
    

Detailed description: 
      Primary endpoint: A cured patients is defined as no subjective symptoms (ICIQ-UI SF and
      ICIQ-OAB) and no objective detectable urinary leakage during coughing (300cc in the bladder
      and no leakage during coughing)

      Secondary outcome: Pain-perception is evaluated by VAS scoring daily during the first
      postoperative week, including assessing the need for painkilling medication

      The endpoint regarding the use of antibiotics is based on the number of urinary tract
      infections and infections related to the vaginal closure during the first postoperative
      months. All patients will evaluated postoperative by physical examination and by urinary
      dipstick
    

Intervention name(s): Ajust system; TVT/TVT-O
Intervention type(s): Procedure; Procedure
Intervention description(s): The use of Ajust system for stress incontinence; sling surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment