A multi-centre randomised comparison of the effectiveness and safety of TVT-O and TVT-S.

TVT has become the standard surgical procedure to correct stress-incontinence.
During TVT a polypropylene mesh is, by vaginal approach, placed below the
mid-urethra. Several variations of the TVT have been developed to improve the
procedure and make it safer. One of these variations is TVT-O during which the
mesh, that is placed below the mid-urethra, leaves the body through the groins.
The mesh crosses at its path several muscles and vessels. This implies that
there is a risk on muscle pain and bleeding.
To reduce the risk on muscle pain and bleeding a new variation of TVT has been
developed. This variation is called TVT-S. During TVT-S the mesh that is placed
below the mid-urethra does not cross muscles or vessels. The path of the mesh
is shorter during TVT-S than during TVT-O as it is vaginally inserted and does
not leave the body through the groins.
In this trial the effectiveness, safety and post-operative pain of TVT-O and
TVT-S are randomly compared.

1. To compare the effectivity of TVT-O and TVT-S as surgical correction of
stress-incontinence.
2. To compare the complications of TVT-O and TVT-S.
3. To compare the morbidity and post-operative recovery of TVT-O and TVT-S.
4. To compare the effectivity of TVT-S performed under [1] local analgesia in
combination with sedation and [2] general anesthesia or spinal analgesia.
5. To compare the need for repeated stress-incontinence surgery or specialized
physiotherapy following both techniques.
6. To compare pelvic floor function following TVT-O and TVT-S.

A randomized multi-centre controlled trial will be performed

TVT-O or TVT-S.

All patients are asked to complete a questionnaire before and at 6 weeks, 3
months and 12 months after surgery. Patients hold a diary from the day of
surgery until 6 weeks after surgery. Patients visit the hospital for additional
visits at 3 months and 12 months after surgery.