Urinary Stress Incontinence Clinical Trial
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
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
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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