Stress urinary incontinence urine loss
Conditions
Interventions
Eligible subjects will receive injections of the PCL-based bulking agent
(Urolon*-12, Urolon*-24, or Urolon*-48). The use of topical, spinal, or general
anesthesia is permitted at the discretion of
Sponsors
AQLANE Medical BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 Q1-3) of >= 4 and Total Urge score (Sum Q4-6) of
Exclusion criteria
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 3. Subjects with urinary retention (postvoid residual volume >=100ml) 4. Subjects with morbid obesity (body mass index (BMI) >=40 kg/m2) 5. Subjects with known allergies to antibiotics 6. Subjects with a neurogenic bladder 7. Subjects who were treated with chemotherapy agents or systemic corticosteroids within 3 months prior to enrollment 8. Subjects with a history of autoimmune disorder 9. Subjects with known allergies to topical, injectable, or general anesthetics 10. Subjects with severe allergies manifested by a history of anaphylaxis or those with severe, chronic allergies (e.g. asthma) 11. Subjects with a known bleeding disorder 12. Subjects with an active infection of any kind at the time of enrollment 13. Subjects with known connective tissue disease 14. Subjects who do not agree to use contraceptives throughout the initial 12 months of the trial 15. Subjects who are pregnant (or within 12 months postpartum) or lactating 16. Subjects who are unwilling and/or unable to comply trial follow-up procedures and schedules 17. Subjects enrolled in another investigational clinical trial 18. Subjects with co-morbidities 19. Subjects with non-viable tissue, e.g. history of significant pelvic irradiation, multiple pelvic surgeries, etc. (scar tissue and significantly compromised tissue will not coapt appropriately) 20. Subjects with urethral or bladder neck strictures (use of bulking agents in patients with strictures may cause injury and/or urethral obstruction) 21. Subjects with peripheral vascular disease and/or prior pelvic surgery may be at increased risk for tissue erosion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Primary analyses - Primary efficacy analysis The primary objective of this trial is to assess the treatment efficacy of the PCL-based bulking agents Urolon*-12, Urolon*-24, and Urolon*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. - Primary safety analysis The primary objective of this trial is to evaluate the safety of the PCL-based bulking agents Urolon*-12, Urolon*-24, and Urolon*48. Counts and rates of treatment-related AE*s and serious AE*s will be presented after treatment (baseline) and at the 3, 6, 12, 18, and 24 month follow-up time points. | — |
Secondary
| Measure | Time frame |
|---|---|
| 2. Secondary analyses - Secondary efficacy analysis The secondary objective of this trial is to assess the efficacy and improvement in patients QoL after treatment with the PCL-based bulking agents Urolon*-12, Urolon*-24, and Urolon*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. - Secondary efficacy and safety analysis 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 | — |
Countries
Netherlands
Outcome results
None listed