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TVT-O versus TVT-S Trial.

A multi-centre randomised comparison of the effectiveness and safety of TVT-O and TVT-S.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23119
Enrollment
200
Registered
2007-11-25
Start date
2007-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Urinary incontinence (NLD: urine incontinentie)

Interventions

Patients are randomised to undergo a TVT-obturator (TVT-O©) or a TVT-Secure (TVT-S©) procedure.

Sponsors

Jan-Paul W.R. Roovers, MD, PhD , Academisch Medisch Centrum, Amsterdam, the Netherlands Piet Hinoul, MD, Ziekenhuis Oost Limburg, Genk, Belgium
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Urodynamically proven urinary stress incontinence.

Exclusion criteria

Exclusion criteria: 1. Stage 2 or more genital prolapse (ICS classification); 2. Recurrent stress-incontinence; 3. Concomitant surgical procedures.

Design outcomes

Secondary

MeasureTime frame
1. 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.—

Primary

MeasureTime frame
Morbidity: 1. A questionnaire to assess activities of daily life; 2. A visual analogue scale (VAS score) to assess the experienced pain.—

Contacts

Public ContactPiet Hinoul

Ziekenhuis Oost Limburg,

piet.hinoul@skynet.be

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)