A prospective multi-national randomized comparison of the effectiveness and safety of MiniArc and Monarc.

• Conditions: stress urinary incontinence; unintended urine loss.; 10029903

• Registration Number: NL-OMON33417
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Female symptomatic stress urinary incontinence resulting from urethral hypermobility and/or ISD (intrinsic sphincter deficiency).

Exclusion Criteria

1. Subjects who have stage 2 or more genital prolaps, according to the ICS-classification
2. Subjects who undergo surgery for recurrence of stress incontinence
3. Subjects who undergo concomitant surgical procedures
4. Subjects who are pregnant or want to become pregnant
5. Subjects are not capable of giving informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. efficacy as surgical correction of stress urinary incontinence.<br /><br>2. post-operative pain.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>3. complications.<br /><br>4. morbidity and post-operative recovery.<br /><br>5. the need for repeated stress-incontinence surgery or specialized<br /><br>physiotherapy.<br /><br>6. pelvic floor function.<br /><br>7. cost-effectiveness from a societal perspective.</p><br>