Tvt-o Or Ajust Stress incontinence Trial
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For the surgical treatment of women with urinary stress incontinence the so-called synthetic midurethral sling has become the Gold-standard. There are two separate ways to place the sling. The first technique is the retropubic approach, the Tension-free Vaginal Tape (TVT®). This technique carries the risk of bladder perforation during surgery. The second approach, the transobturator route (TVT-O®), has an almost zero risk of bladder perforation but is associated with more groin pain as compared to the retropubic TVT®. The groin pain is most likely due to perforation of the external obturator and adductor muscles of the upper leg. The new transobturator device Ajust® does not penetrate these muscles and is therefore in theory less painful as compared to the TVT-O®, with the benefit of reducing the risk of bladder perforation as compared to the retropubic TVT®.
Objective cure of the SUI at 6 and 12 months follow up
Subjective cure and improvement of the SUI at 6 and 12 months follow up
Complications during and after the procedures
De novo obstructive or irritative bladder symptoms
Time to return to normal daily activities/work
With this sample size a difference of 20% in objective cure rate can be detected (for instance 85% versus 65%). Such a difference can be regarded as clinical relevant and would favor one of the two techniques for future use.
K.J. Schweitzer, MD, Dept. of Gynaecology, UMC Utrecht
D.A. Gietelink, MD, PhD - Amphia Ziekenhuis
A.L. Milani, MD, - Reinier de Graaf Groep
E. Hallensleben, MD – Groene Hart Ziekenhuis
H. van Eijndhoven, MD, PhD – Isala Klinieken
C.H. van der Vaart, MD, PhD - UMC Utrecht / ZBC Alant Vrouw Bilthoven
K.J. Schweitzer, MD - UMC Utrecht / ZBC Alant Vrouw Bilthoven.