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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00996489
First received: October 14, 2009
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals, LLC:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • To assess the long term safety of Coaptite® using physical exams and other diagnostic tests [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 459
Study Start Date: November 2007
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Coaptite Device: Coaptite®
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Pharmaceuticals, LLC
  More Information

No publications provided

Responsible Party: Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00996489     History of Changes
Other Study ID Numbers: P1005185
Study First Received: October 14, 2009
Last Updated: July 1, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014