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

Completed

• Conditions: stress urinary incontinence; urinary loss; 10018188

• Registration Number: NL-OMON34244
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 145

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference between the Ajust® and TVT-O® procedure in immediate and<br /><br>postoperative pain (up to 6 weeks)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The difference between the procedures in immediate and postoperative pain (up<br /><br>to 6 weeks), complications, obstructive or irritative bladder symptoms,<br /><br>objective and subjective cure, and resuming daily activities.</p><br>