N/A
Completed N=459
This is a Post Approval Study of Coaptite® in the Treatment of Female Urinary Incontinence
Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
Source: ClinicalTrials.gov NCT00996489 ↗
Enrolled (actual)
459
Serious AEs
35.5%
Results posted
Jul 2019
Primary outcomePrimary: Incontinence Status as Assessed by Stamey Grade Score — 2.5; 1.6; 1.5; 1.6 score on a scale
Summary
This is a post approval study of Coaptite® in the treatment of female urinary incontinence.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incontinence Status as Assessed by Stamey Grade Score |
2.5; 1.6; 1.5; 1.6; 1.5; 1.5 | — |
| PRIMARY Number of Participants With One Point Improvement in Stamey Grade Scores up to Month 12 |
171 | — |
| PRIMARY Number of Participants Who Had at Least One Point Improvement in Stamey Grade Scores Compared to Baseline |
229; 234; 208; 221; 200; 199 | — |
| PRIMARY Number of Participants With Change From Baseline in Stamey Grade Scores Over Time |
408; 391 | — |
| PRIMARY Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) |
313 | — |
| SECONDARY Number of Participants Who Received Each of the Six Coaptite Injections |
458; 262; 90; 26; 7; 1 | — |
| SECONDARY Time to Coaptite Retreatment |
150.1; 212; 227.1; 164; 105 | — |
| SECONDARY Number of Participants With Alternative Treatments for Incontinence |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Urge Incontinence Medication (UIM) Status |
52 | — |
| SECONDARY Incontinence Quality of Life (iQoL) Scores |
39.5; 69.6; 70.3; 70.4; 71.2; 73.5 | — |
| SECONDARY Volume of Coaptite Injected Per Treatment |
1.8; 1.8; 1.5; 2.0; 1.7; 1.7 | — |
| SECONDARY Mean Number of Sites Injected by Coaptite |
2.4; 2.4; 2.5; 2.6; 2.5; 2.9 | — |
Eligibility Criteria
Inclusion Criteria
- Has female stress urinary incontinence that is due to intrinsic sphincter deficiency
- Has a baseline pad weight of greater than or equal to 50 grams
- Has viable mucosal lining at likely site of injection (bladder neck)
- Is at least 18 years of age
- Understands and accepts the obligation and is logistically able to present for all scheduled study visits
- Signs written informed consent
Exclusion Criteria
- Has had a previous treatment for urinary incontinence with a urethral bulking agent other than Coaptite® or collagen
- Has detrusor instability
- Has bladder neuropathy
- Has nocturnal enuresis (bed wetting)
- Has Grade II or III prolapsed bladder
- Has overflow or functional incontinence
- Has significant history of urinary tract infections without resolution
- Has current or acute conditions of cystitis or urethritis
- Has history of significant pelvic irradiation
- Is pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT00996489). 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. Informational only — not medical advice.