The use of a Polycaprolactone Based Bulking Agent for the Treatment of Female Stress Urinary Incontinence, a Pivotal Trial

Completed

• Conditions: Stress urinary incontinence; urine loss; 10046590

• Registration Number: NL-OMON43407
• Lead Sponsor: AQLANE Medical BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 35

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 < 6.
3. Subjects who attempted or failed prior noninvasive pelvic muscle rehabilitation treatment while incontinent.
4. Subjects with mild to moderate SUI as confirmed by SGS 1 or 2
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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Primary analyses<br /><br><br /><br>- Primary efficacy analysis<br /><br>The primary objective of this trial is to assess the treatment efficacy of the<br /><br>PCL-based bulking agents Urolon*-12, Urolon*-24, and Urolon*48 as determined by<br /><br>the SGS.<br /><br>The efficacy endpoint is a reduction of at least 1 SGS at 3, 6, 12, 18, and 24<br /><br>months follow-up compared to baseline.<br /><br><br /><br>- Primary safety analysis<br /><br>The primary objective of this trial is to evaluate the safety of the PCL-based<br /><br>bulking agents Urolon*-12, Urolon*-24, and Urolon*48. Counts and rates of<br /><br>treatment-related AE*s and serious AE*s will be presented after treatment<br /><br>(baseline) and at the 3, 6, 12, 18, and 24 month follow-up time points.</p><br>