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TVT-O versus TVT-S Trial.


- candidate number2913
- NTR NumberNTR1141
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-nov-2007
- Secondary IDsincomplete 
- Public TitleTVT-O versus TVT-S Trial.
- Scientific TitleA multi-centre randomised comparison of the effectiveness and safety of TVT-O and TVT-S.
- ACRONYMN/A
- hypothesisWe hypothesize that TVT-O and TVT-S are equally effective in the management of stress-incontinence. We hypothesize that there are differences in morbidity and post-operative recovery between both procedures as TVT-S it is a less invasive technique.
- Healt Condition(s) or Problem(s) studiedUrinary incontinence
- Inclusion criteriaUrodynamically proven urinary stress incontinence.
- Exclusion criteria1. Stage 2 or more genital prolapse (ICS classification);
2. Recurrent stress-incontinence;
3. Concomitant surgical procedures.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2007
- planned closingdate1-apr-2008
- Target number of participants200
- InterventionsPatients are randomised to undergo a TVT-obturator (TVT-O) or a TVT-Secure (TVT-S) procedure.
- Primary outcomeMorbidity:
1. A questionnaire to assess activities of daily life;
2. A visual analogue scale (VAS score) to assess the experienced pain.
- Secondary outcome1. General specific quality of life: SF-36;
2. Disease specific quality of life: Urogenital;
3. Distress Inventory (UDI);
4. Anatomical result POP-Q score;
5. Bladder function: voiding diary and uroflowmetry;
6. Urogenital interventions in the first year after stress incontinence surgery;
7. Catheter use.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. Piet Hinoul
- CONTACT for SCIENTIFIC QUERIESMD. Piet Hinoul
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Johnson & Johnson
- PublicationsN/A
- Brief summaryThe purpose of the proposed study is:
1. To compare the effectivity of TVT-O and TVT-S as surgical correction of stress-incontinence;
2. To compare the complications of TVT-O and TVT-S;
3. To compare the morbidity and post-operative recovery of TVT-O and TVT-S;
4. To compare the need for repeated stress-incontinence surgery or specialized physiotherapy following both techniques;
5. To compare pelvic floor function following both techniques.
- Main changes (audit trail)
- RECORD25-nov-2007 - 4-jun-2008


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