The use of a bulking agent (UrolonTM) for the treatment of Female Stress Urinary Incontinence.
Recruiting
- Conditions
- Stress Urinary Incontinence (SUI)Female Subjects 18 years of age or older
- Registration Number
- NL-OMON28659
- Lead Sponsor
- AQLANE Medical BV.Yalelaan 1, 3584 CL UtrechtThe Netherlands
- Brief Summary
ot applicable
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
1. Subjects 18 years of age or older
2. Subjects with predominant SUI as determined by the Questionnaire for Urinary Incontinence Diagnosis (QUID); Total Stress Score (Sum Q1-Q3) of > or equal to 4 and Total Urge Score (Sum Q1-Q6) of < 6.
Exclusion Criteria
1. Subjects who have received previous bulking agent implantation in the submucosa of the urethra or had any form of surgery to treat SUI.
2. Subjects with any form of urinary incontinence other than predominant SUI.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The primary objective of this trial is to assess the treatment efficacy of the PCL-based bulking agent (UrolonTM-12, UrolonTM-24 and UrolonTM-48) as determined by the SGS. The efficacy endpoint is a reduction of at least 1 SGS at 3, 6, 12, 18, and 24 months follow-up compared to baseline.<br /><br>2. The primary objective of this trial is to evaluate the safety of the PCL-based bulking agent (UrolonTM-12, UrolonTM-24 and UrolonTM-48). Counts and rates of treatment-related AE's and SAE's will be presented immediately after treatment (baseline) and at the 3, 6, 12, 18 and 24 follow-up time points.
- Secondary Outcome Measures
Name Time Method 1. The secondary objective of this trial is to assess the efficacy and improvement in patients QoL after treatment with the PCL-based bulking agents (UrolonTM-12, UrolonTM-24 and UrolonTM-48) as determined with the I-QoL, ICIQ-SF, PGI-I, PGI-S and non-invasive cough test. The efficacy and QoL endpoints are improvement at 3, 6, 12, 18 (no cough test at this time point) and 24 months follow-up compared to baseline with the use of the I-QoL, ICIQ-SF, PGI-I, PGI-S and non-invasive cough test. The non-invasive cough test will be performed after treatment to test post-treatment success.<br /><br>2. The secondary objective of this trial is to assess the long-term safety and efficacy which will be assessed by extending the follow-up visits annually up to 5 years. (SGS, I-QoL, PGI-I, PGI-S and ICIQ-SF). Evaluate safety via an additional cystoscopic examination at 12 and 24 months follow-up.