A randomised controlled trail comparing the TVT-O® with the Ajust® as primary surgical treatment of female stress urinary incontinence.

A randomised controlled trail comparing the TVT-O® with the Ajust® as primary surgical treatment of female stress urinary incontinence. - TOAST

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34244

Enrollment

145

Registered

2010-08-25

Start date

2010-08-26

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

stress urinary incontinence urinary loss

Interventions

The TVT-O® device will be compared to the Ajust® device

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Predominant stress urinary incontinence 2. The stress urinary incontinence is confirmed during physical examination, stress test or urodynamic assessment. 3. They have completed conservative treatment for their stress urinary incontinence, pelvic floor muscle training program

Exclusion criteria

Exclusion criteria: 1. A post voiding bladder volume of more than 100 ml. 2. History of anti-incontinence surgery 3. Genital prolapse Stage 2 or more according to the POP-Q classification 4. Patients desire for future pregnancy and childbirth 5. Co-morbidity

Design outcomes

Primary

Measure	Time frame
The difference between the Ajust® and TVT-O® procedure in immediate and postoperative pain (up to 6 weeks)	—

Secondary

Measure	Time frame
The difference between the procedures in immediate and postoperative pain (up to 6 weeks), complications, obstructive or irritative bladder symptoms, objective and subjective cure, and resuming daily activities.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)