N/A
N=345
Bulking Agents for the Treatment of Stress Urinary Incontinence in Females
Stress Urinary Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT00629083 ↗Enrolled (actual)
345
Serious AEs
1.5%
Results posted
Feb 2020
Primary outcome: Primary: Primary Effectiveness Endpoint — 107; 50 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bulkamid (Device); Contigen (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Contura
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Effectiveness Endpoint |
107; 50 | — |
| PRIMARY The Number of Participants With Device- and Procedure-related Serious Adverse Events Through 12 Months Follow-up. |
1; 0 | — |
| SECONDARY 24hr Pad Test |
32.0; 54.6 | — |
| SECONDARY Number of Subjects Reporting as a Responder |
144; 71 | — |
| SECONDARY IQoL |
80.3; 75.2 | — |
| SECONDARY ICIQ-UI Short Form |
7.1; 7.9 | — |
| SECONDARY Number of Incontinence Episodes |
1.4; 1.4 | — |
Summary
The primary purpose of this study is to demonstrate the safety and effectiveness of Bulkamid® in the treatment of stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) in adult women who have SUI or stress predominant mixed incontinence
Eligibility Criteria
Inclusion Criteria
- Be female 18 or more years of age.
- Females of childbearing potential or 30 deg.
- Has predominant urge incontinence.
- Has detrusor overactivity.
- Regularly or intermittently users of urethral catheter.
- Has had previous radiation treatment in the pelvic floor.
- Has had previous urethral surgery (i.e. fistula, diverticula)or urethral bulking. Failed sling or colposuspension procedure for at least 6 months may be included.
- Suffers from known polyuria.
- Has had three (3) or more culture-proven bacterial UTIs in the last 12 months.
- Has a current infection (urethritis, cystitis or vaginitis).
- Has unevaluated hematuria.
- Has a Prolapse Stage greater than II.
- Has a BMI>35 kg/m2.
- Is taking pharmacological treatment for stress urinary incontinence, 4 weeks prior to screening.
- Is allergic to bovine collagen.
- Is known to suffer from severe allergies or anaphylaxis.
- Suffers from autoimmune diseases (e.e. connective tissue diseases) that could confound the treatment.
- Is currently taking or has taken systemic corticosteroids within the past 3 months.
- Currently has cancer or has a history of any cancer within the past 5 years (skin cancer with no evidence of skin malignancy, for at least 2 years, can be included).
- Currently suffering from unstable cardiovascular disease, cancer or uncontrolled diabetes.
- Has active herpes genitalis.
- Is currently participating in any other clinical trial or has participated in another clinical trial within 3 months of screening/baseline visit.
- Is pregnant, lactating or intending to become pregnant.
- Is not physically able to perform study procedure.
- Has a neurogenic bladder
- Had a vaginal delivery within 3 months prior to screening.
Data sourced from ClinicalTrials.gov (NCT00629083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.