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.
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
POWER / DATA ANALYSIS:
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 á 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.