A trial comparing two different tapes used for surgical treatment of stress urinary incontinence.

Rationale:

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:

Primary Objective: To compare the immediate and postoperative pain (up to 6 weeks) between the Ajust® and TVT-O® procedures.

Secondary Objective(s):

1. Objective cure of the SUI at 6 and 12 months follow up;

2. Subjective cure and improvement of the SUI at 6 and 12 months follow up;

3. Complications during and after the procedures;

4. De novo obstructive or irritative bladder symptoms;

5. Time to return to normal daily activities/work.



Study design:

Randomised controlled trial.



Study population:

Woman between 35 - 80 years of age with urinary stress incontinence.



Intervention:

The TVT-O® device will be compared to the Ajust® device.



Main study parameters/endpoints:

The difference between the Ajust® and TVT-O® procedure in immediate and postoperative pain (up to 6 weeks), complications, obstructive or irritative bladder symptoms, objective and subjective cure, and resuming daily activities.



Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

The burden related to the study is minimal. It mainly consists of the use questionnaires at regular intervals and weekly telephone interviews (up to 6 weeks) of approximately 5-10 minutes. Except for the one year follow-up all other visits are part of the regular care. No additional risks, other than those that are known to be related to any stress incontinence surgery, are expected to be related to the new Ajust® device. The Ajust® device is officially registered in Europe and clinical available.

Reducing postoperative pain with a mini-sling.

Inclusion 12-18 months.

Mid uerthral sling placement ( TVT-O or ajust).