A prospective multi-national randomized comparison of the effectiveness and safety of MiniArc and Monarc.

Stress urinary incontinence (SUI) is a worldwide common problem, especially
suffering women. In the past many operative techniques are developed to treat
stress urinary incontinence. One of the most successful techniques is the
TVT-procedure (tension free vaginal tape). Since its introduction, more than
1,000,000 procedures with TVT have been performed worldwide. A recent Cochrane
review concluded that the cure rates after TVT placement were similar to those
after open abdominal retropubic suspension with a low complication rate.
Initially suburethral tapes followed a retropubic route during insertion.
Later, the trans-obturator route was developed. One of the most used
transobturator slings is the Monarc. It has been shown that the trans-obturator
route is associated with a lower risk on post-operative bladder retention and
overactive bladder symptoms. Furthermore, the trans-obturator route is safer
as, during this procedure, it is almost impossible to perforate the bladder.
However, trans-obturator slings also carry some risk on morbidity of which
muscle pain (due to perforation of the obturator muscles) and bleeding (due to
perforation of the obturator vessels) are the most important. With the
intention to reduce the invasiveness of the retropubic and trans-obturator
approach, the MiniArc was developed.

To randomly compare MiniArc and Monarc for:

* efficacy as surgical correction of stress-incontinence
* post-operative pain
* complications
* morbidity and post-operative recovery
* the need for repeated stress-incontinence surgery or specialized physiotherapy
* pelvic floor function
* cost-effectiveness from a societal perspective

Prospective multi-national randomised controlled trial.

Surgical correction of symptomatic stress-incontinence with mini-sling
(MiniArc) or trans-obturator sling (Monarc) .

Burden: Before operation, 4 weeks and 12 months after operation, patients are
asked to fill in a validated questionnaire concerning pelvic floor problems and
general functioning. Also they have to complete a diary during the first 4
weeks after operation, concerning pain, use of analgetics and activities of
daily life. 6 Months after operation an interview by telephone will take place
to complete a short questionnaire (15 min). All questionnaires together takes
approximatively 2 hours spread over 12 months.
Risk: Both operative techniques (MiniArc and Monarc) are well accepted
procedures to treat stress urinary incontinence in women. In many centres these
procedures are commonly used. Therefore no extra risks are connected with
inclusion in the trial.