A trial comparing two different tapes used for surgical treatment of stress urinary incontinence.

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20238

Enrollment

145

Registered

2010-10-06

Start date

2010-09-01

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

urinary stress incontinence mid urethral sling TVT-O Ajust

Interventions

Mid uerthral sling placement ( TVT-O or ajust).

Eligibility

Inclusion criteria

Inclusion criteria: 1. Predominant stress incontinence; 2. Stress incontinence is confirmed; 3. Completed conservative therapy; 4. Sandvic index >3; 5. Good knowledge of dutch language.

Exclusion criteria

Exclusion criteria: 1. Postvoid residual volume > 100cc; 2. History of anti-incontinence surgery; 3. Prolapse POPQ st 2 or >; 4. Desire for future pregnancy / childbirth; 5. Co-morbidity (ASA 3 or 4); 6. History of recurrent cystitis; 7. Psychiatric illness; 8. Poor cognitive function; 9. Chronic or current neurologic illness.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is the immediate and postoperative pain (up to 6 weeks) after an Ajust® or TVT-O® procedure.	—

Secondary

Measure	Time frame
Objective cure of the SUI at 6 and 12 months follow up: 1. Subjective cure and improvement of the SUI at 6 and 12 months follow up; 2. Complications after the procedures; 3. De novo obstructive or irritative bladder symptoms; 4. Time to return to normal daily activities/work.	—

Contacts

Public ContactK.J. Schweitzer

Postbus 85500

k.j.schweitzer@umcutrecht.nl+31 (0)88 7555555

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)