An interventional study of Ajust system and TVT/TVT-O in Urinary Stress Incontinence, sponsored by Zealand University Hospital. Completed at 1 site in Denmark. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2014-05-02.
Sponsored by Zealand University Hospital · Not applicable, Interventional, and Treatment
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:
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
658 studies on the registry are indexed under Urinary Incontinence, Stress; 123 are open to participants now.
This study's planned enrollment of 500 is above the median of 70 across 509 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Zealand University Hospital is the lead sponsor of 234 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
The sling a a new device for stress urinary incontinence. The sling is ajustable and is not penetrating the skin, i.e. is only attached to the obturator membrane
Procedure: Ajust system · Procedure: TVT/TVT-O
TVT/TVT-O system. These two systems is wellknown and used for treatment of stress urinary incontinence. The sling penetrate the skin in order to secure adjustment.
Procedure: Ajust system · Procedure: TVT/TVT-O
The use of Ajust system for stress incontinence
sling surgery
A change in number of cured patients
Primary endpoint: A change in number of cured patients. The number of patients cured is anticipated to be equal in each group. A cured patients is defined as having no subjective symptoms (i.e. no scores on the ICIQ-UI SF and ICIQ-OAB) and no objective detectable urinary leakage during coughing (300cc in the bladder and no leakage during coughing.
Time frame: Up to 1 year
Pain-perception following surgery
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
Time frame: Evaluated the first week following surgery, and at three and 12 months follow-up
number of urinary tract infections and infections related to the vaginal closure during the first postoperative months.
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
Time frame: Evaluated during the first week of follow-up and at 3 months follow-up
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Zealand University Hospital