Stress Urinary Incontinence (SUI) Female Subjects 18 years of age or older
Conditions
Interventions
Eligible subjects will receive injections of the PCL-based bulking agent (UrolonTM-12
UrolonTM-24
or UrolonTM-48). The use of topical and/or local anesthesia is permitted at the discretion of the investigator. The PCL-based bulking agent injection will be administrated into the submucosa of the ur
Sponsors
AQLANE Medical BV.
Yalelaan 1, 3584 CL Utrecht
The Netherlands
Eligibility
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-Q3) of > or equal to 4 and Total Urge Score (Sum Q1-Q6) of < 6. 3. Subjects with mild to moderate SUI as confirmed by SGS 1 or 2. 4. Subjects who attempted or failed prior noninvasive pelvic muscle rehabilitation treatment while incontinent. 5. Subjects willing and able to comply with study follow-up procedures and schedule. 6. Subjects willing to provide written informed consent for their participation in the trial.
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 (post void residual volume > or equal to 100mL) 4. Subjects with morbid obesity (body mass index BMI > or equal to 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 approprately). 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/pr pelvic surgery may be at increased risk for tissue erosion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 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
| Measure | Time frame |
|---|---|
| 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. 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. | — |
Contacts
Public ContactAlex Lankhorst
AQLANE Medical BV.
Outcome results
None listed