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TVT-O versus TVT-S 


Een multi-centre gerandomiseerde vergelijking van de effectiviteit en veiligheid van TVT-O en TVT-S.


Go to the TVT O/S website.



1. To compare the effectivity of TVT-Obturator (TVTO-O) and TVT-Secure (TVT-S) as a surgical treatment of urodynamic stress-incontinence.

2. To compare the complications, the morbidity and post-operative recovery related to the TVT-O versus the TVT-S procedure.



Prospective, randomized controlled trial comparing two minimally invasive interventions (TVT-O versus TVT-S) in women who are candidate to undergo surgical treatment of proven, symptomatic urodynamic stress-incontinence.



Patients who are planned to undergo surgical correction of symptomatic stress-incontinence are asked to participate in the study. Patients who have stage 2 or more genital prolapse (ICS classification) are excluded. Patients who undergo surgery for recurrence of stress-incontinence are excluded as are patients who undergo concomitant surgical procedures. Prior to surgery urodynamic investigation is performed in all patients.



Patients are randomised to undergo a TVT-obturator (TVT-O) or a TVT-Secure (TVT-S) procedure. Both procedures are carried out under regional or general anaesthesia whilst strictly adhering to the insertion guidelines of both needle procedures.




-A questionnaire to assess activities of daily life.

-A visual analogue scale (VAS score) to assess the experienced pain

Duration of catheter use

General specific quality of life: SF-36

Disease specific quality of life: Urogenital Distress Inventory (UDI)

Anatomical result POP-Q score

Bladder function: voiding diary and uroflowmetry

Performed interventions in the first year after stress incontinence surgery



We consider the incontinence domain of the UDI to be the most important outcome measurement. If the differences in stress domain score would exceed 6 points we would conclude that either the TVT-O or TVT-S is not preferable even if beneficial effects with respect to morbidity would be observed.

Based on the variation in domain scores of the UDI, power calculation was based on a standard deviation of 12. With a power of 80% and an level of 0.05, the calculated sample size necessary is 64 in each group.



Patient recruitment starts April 01, 2007.and inclusion is aimed to finish April 01, 2008.



Jan-Paul W.R. Roovers, MD, PhD , Amsterdam, the Netherlands

Piet Hinoul, MD, Genk, Belgium



St.Elisabeth Ziekenhuis, Tilburg

Academisch Medisch Centrum, Amsterdam

Ziekenhuis Oost-Limburg Genk - Belgie

Haga Hospital Den Haag

Reinier de Graaf Hospital - Delft

Isala Hospital - Zwolle



Dr. J.P. Roovers: J.P.Roovers@amc.uva.nl



An unconditional grant to partially cover the administrative costs of the study was provided by Johnson & Johnson Medical (Ethicon-Women's Health & Urology), 3821 AB Amersfoort, the Netherlands.