This is a Post Approval Study of Coaptite® in the Treatment of Female Urinary Incontinence

Post-approval of Coaptite® in the Treatment of Female Urinary Incontinence

This is a post approval study of Coaptite® in the treatment of female urinary incontinence.

Study Overview

• Status: Completed
• Conditions: Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
• Intervention / Treatment: Device: Coaptite®

• Study Type: Interventional
• Enrollment (Actual): 459
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Wetumpka, Alabama, United States
  • Arizona
    • Surprise, Arizona, United States
  • California
    • Encinitas, California, United States
    • Los Angeles, California, United States
    • Oceanside, California, United States
    • Orange, California, United States
    • Templeton, California, United States
  • Florida
    • Celebration, Florida, United States
    • Orlando, Florida, United States
    • Saint Petersburg, Florida, United States
  • Illinois
    • Berwyn, Illinois, United States
    • Evanston, Illinois, United States
  • Kansas
    • Overland Park, Kansas, United States
  • Michigan
    • Grand Rapids, Michigan, United States
  • Missouri
    • Saint Louis, Missouri, United States
  • New York
    • Rochester, New York, United States
  • Ohio
    • Akron, Ohio, United States
  • Texas
    • Houston, Texas, United States
    • Temple, Texas, United States
  • Washington
    • Mountlake Terrace, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coaptite	Device: Coaptite®; Calcium hydroxylapatite particles suspended in an aqueous based gel carrier

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incontinence Status as Assessed by Stamey Grade Score	The Stamey grade classifies the severity stress incontinence and was calculated from the 4-day voiding diary using the four possible grades from 0-3. Grade 0: controlled urination, Grade 1: accidents with vigorous activity, for example, lifting weights, coughing, and sneezing, Grade 2: accidents with minimal activity, for example, walking and standing up, and Grade 3: accidents regardless of activity or position and that cannot be attributed to a specific activity. Higher the Stamey grade, the most severe leakage level was estimated. An average of 4 days for the final grade was recorded and rounded up, if necessary (for example, 2.5 was equal to Grade 3).	Baseline and Months 6, 12, 18, 24, 30, and 36
Number of Participants With One Point Improvement in Stamey Grade Scores up to Month 12	The Stamey grade classifies the severity stress incontinence and was calculated from the 4-day voiding diary using the four possible grades from 0-3. Grade 0: controlled urination, Grade 1: accidents with vigorous activity, for example, lifting weights, coughing, and sneezing, Grade 2: accidents with minimal activity, for example, walking and standing up, and Grade 3: accidents regardless of activity or position and that cannot be attributed to a specific activity. Higher the Stamey grade, the most severe leakage level was estimated. An average of 4 days for the final grade was recorded and rounded up, if necessary (for example, 2.5 was equal to Grade 3).	Baseline up to Month 12
Number of Participants Who Had at Least One Point Improvement in Stamey Grade Scores Compared to Baseline	The Stamey grade classifies the severity stress incontinence and was calculated from the 4-day voiding diary using the four possible grades from 0-3. Grade 0: controlled urination, Grade 1: accidents with vigorous activity, for example, lifting weights, coughing, and sneezing, Grade 2: accidents with minimal activity, for example, walking and standing up, and Grade 3: accidents regardless of activity or position and that cannot be attributed to a specific activity. Higher the Stamey grade, the most severe leakage level was estimated. An average of 4 days for the final grade was recorded and rounded up, if necessary (for example, 2.5 was equal to Grade 3).	Months 6, 12, 18, 24, 30, and 36
Number of Participants With Change From Baseline in Stamey Grade Scores Over Time	The Stamey grade classifies the severity stress incontinence and was calculated from the 4-day voiding diary using the four possible grades from 0-3. Grade 0: controlled urination, Grade 1: accidents with vigorous activity, for example, lifting weights, coughing, and sneezing, Grade 2: accidents with minimal activity, for example, walking and standing up, and Grade 3: accidents regardless of activity or position and that cannot be attributed to a specific activity. Higher the Stamey grade, the most severe leakage level was estimated. An average of 4 days for the final grade was recorded and rounded up, if necessary (for example, 2.5 was equal to Grade 3).	Baseline up to Months 6 and 12
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)		Baseline up to Month 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Received Each of the Six Coaptite Injections	Coaptite injection were given to any participant during the 36 months of evaluation.	Baseline up to Month 36
Time to Coaptite Retreatment	Time to additional coaptite treatment or any other alternative treatment for stress urinary incontinence was recorded to assess the durability of effect.	Baseline up to Month 36
Number of Participants With Alternative Treatments for Incontinence	Number of participants with alternative treatment such as kegel exercises, sling, sling/cystocele repair, surgery, permanent abdominal tube, intravesical botox, sling/graft, sling removal, estradiol vaginal cream, bladder neck suspension, tension free vaginal tape, biofeedback, polydimethylsiloxane injections, solifenacin orally, bladder specific control physical therapy, for stress urinary incontinence were assessed.	Baseline up to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36
Number of Participants With Urge Incontinence Medication (UIM) Status	The use of urge incontinence medications was collected pre-treatment and post-treatment.	Baseline up to Month 36
Incontinence Quality of Life (iQoL) Scores	The iQoL measured the effect of urinary incontinence on QoL. It was divided into 3 subscales: 1 (avoidance and limiting behaviour); 2 (psychosocial impact), and 3 (social embarrassment). The iQOL was comprised of 22 items, each with the response scale from 1 (extremely) to 5 (not at all). A mean score for each subscale was calculated (averaging the scores for the items in each subscale) as well as a total score for all 22 items (sum of all subscale scores). The scores were then transformed to a scale score ranging from 0 to 100 points, where higher scores indicated less impact of incontinence on QoL.	Baseline and Months 6, 12, 18, 24, 30, and 36
Volume of Coaptite Injected Per Treatment		Baseline, Baseline to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36
Mean Number of Sites Injected by Coaptite		Baseline, Baseline to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36

Collaborators and Investigators

• Sponsor: Merz North America, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2008
• Primary Completion (Actual): October 26, 2015
• Study Completion (Actual): November 2, 2015

Study Registration Dates

• First Submitted: October 14, 2009
• First Submitted That Met QC Criteria: October 15, 2009
• First Posted (Estimate): October 16, 2009

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 1, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urination Disorders; Elimination Disorders; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
• Other Study ID Numbers: P1005185