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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30427

Enrollment

150

Registered

2007-01-03

Start date

2007-01-01

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

stress incontinence (involunatary leakage of urine during exercise)

Interventions

TVT-O or TVT-S.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: patients undergoing surgical correction of stress-incontinence

Exclusion criteria

Exclusion criteria: -recurrent stress-incontinence - genital prolapse requiring surgical intervention - patients requiring additional surgical procedures

Design outcomes

Secondary

Measure	Time frame
1. Morbidity 2. POP-Q score (Anatomical effect) 3. General quality of life 4. Duration of catheter use 5. Performed surgical procedures in the first year after primary cystocele repair.	—

Primary

Measure	Time frame
Disease specific quality of life.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)