Evaluation of the patients* satisfaction and safety of a non-degradable urethral bulking agent for female stress urinary incontinence

Phase 4

Completed

• Conditions: stress urinary incontinentce; urinary incontinence; 10004994

• Registration Number: NL-OMON46734
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 75

Inclusion Criteria

Women:
- > 18 years
- who underwent treatment with bulkinjection therapy Urolastic for stress urinary incontinence

Exclusion Criteria

Incapable of giving informed consent

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Improvement of symptoms assessed by the patients global impression of<br /><br>improvement (PGI-I)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Patient satisfaction on results of the treatment by assessed by three<br /><br>validated questions<br /><br>2. Number of procedure related adverse events: hematoma, urinary retention,<br /><br>urgency incontinence, pain, dyspareunia, urinary tract infection, infection at<br /><br>the injection site, exposure or erosion of the bulk material.<br /><br>3. Re-intervention rate: number of re-injection and excision of PDMS and other<br /><br>surgical treatments for persistent or recurrent SUI after PDMS.<br /><br>4. Objective cure assessed by cough stress test</p><br>