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

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ClinicalTrials.gov Identifier: NCT00996489
Recruitment Status : Completed
First Posted : October 16, 2009
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Merz North America, Inc.

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

Condition or disease Intervention/treatment Phase
Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency Device: Coaptite® Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 459 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2007
Actual Primary Completion Date : November 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Coaptite Device: Coaptite®
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier



Primary Outcome Measures :
  1. To assess the long term effectiveness of Coaptite® using voiding diaries, recording number of and time to additional/alternative treatments,and assessing the impact of re-treatment. [ Time Frame: 3 years ]
  2. To assess the long term safety of Coaptite® using physical exams and other diagnostic tests [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00996489


Locations
United States, Alabama
Wetumpka, Alabama, United States
United States, Arizona
Surprise, Arizona, United States
United States, California
Encinitas, California, United States
Los Angeles, California, United States
Oceanside, California, United States
Orange, California, United States
Templeton, California, United States
United States, Florida
Celebration, Florida, United States
Orlando, Florida, United States
St. Petersburg, Florida, United States
United States, Illinois
Berwyn, Illinois, United States
Evanston, Illinois, United States
United States, Kansas
Overland Park, Kansas, United States
United States, Michigan
Grand Rapids, Michigan, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New York
Rochester, New York, United States
United States, Ohio
Akron, Ohio, United States
United States, Texas
Houston, Texas, United States
Temple, Texas, United States
United States, Washington
Mountlake Terrace, Washington, United States
Sponsors and Collaborators
Merz North America, Inc.

Responsible Party: Merz North America, Inc.
ClinicalTrials.gov Identifier: NCT00996489     History of Changes
Other Study ID Numbers: P1005185
First Posted: October 16, 2009    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders