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 > TVT-O vs TVT-S
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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.

  

OBJECTIVE:

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.

 

STUDY DESIGN:

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.

 

STUDY POPULATION:

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.

 

INTERVENTION:

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.

 

OUTCOME MEASURES:

Morbidity

-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 level of 0.05, the calculated sample size necessary is 64 in each group.

 

TIME-SCHEDULE:

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

 

PROJECTLEADER:

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

Piet Hinoul, MD, Genk, Belgium

 

PARTICIPATING HOSPITALS:

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

 

CONTACT:

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

 

SUBSIDY:

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.