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TOAST

 

Tvt-o Or Ajust Stress incontinence Trial

Go to the TOAST website

 

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):

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


Study design
Randomised controlled trial

Study population
Women between 35 - 80 years of age with urinary stress incontinence

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

 

Outcome measures
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

Power/analysis
We used the pain score at 24 hours after TVT-O® surgery, as measured with a 100 mm Visual Analogue Scale (unpublished data from our practice) to calculate sample size.
The 24 hour pain score of the TVT-O® has a mean value of 30 (standard deviation 21). In order to detect a difference with a minimal effect size of 0.5 (mean difference between groups/ standard deviation) a reduction of pain score with 11 points to a mean value of 19 is necessary.  This change of 11 points can be detected at an alpha of 0.05, a power of 80% at an allocation ratio of 2:1 with 44 women in the TVT-O® group and 88 women in the Ajust® group. To account for a loss to follow-up of 15% a total of 152 women have to be randomised.

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.

Time schedule
Start inclusion: august 2010,  Inclusion period 12 months, follow up period 12months.

Projectleaders
C.H. van der Vaart, MD, PhD, Dept. of Gynaecology, UMC Utrecht

 

Study Coordinator

K.J. Schweitzer, MD, Dept. of Gynaecology, UMC Utrecht

 

Participating gynaecologists

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.


Methodology
K. Fisher,MD,PhD epidemiologist Julius Center, UMC Utrecht


Subsidy
A grant to cover the administrative costs of the study was provided by BARD company