Female Stress Urinary Incontinence Due to Intrinsic Sphincter DeficiencyNCT00996489
This is a Post Approval Study of Coaptite® in the Treatment of Female Urinary Incontinence
A study testing Coaptite® in people with Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency, run by Merz North America, Inc. at 20 sites in United States.
Trial summary
This is a post approval study of Coaptite® in the treatment of female urinary incontinence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
- What is being tested?
- Coaptite®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 459 participants
- Where
- 20 sitesUnited States
- Study dates
- 8 Jan 2008to 2 Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Study site
Akron, Ohio
Study site
Berwyn, Illinois
Study site
Celebration, Florida
Study site
Encinitas, California
Study site
Evanston, Illinois
Study site
Grand Rapids, Michigan
Study site
Houston, Texas
Study site
Los Angeles, California
Study site
Mountlake Terrace, Washington
Study site
Oceanside, California
Study site
Orange, California
Study site
Orlando, Florida
Study site
Overland Park, Kansas
Study site
Rochester, New York
Study site
St Louis, Missouri
Study site
St. Petersburg, Florida
Study site
Surprise, Arizona
Study site
Temple, Texas
Study site
Templeton, California
Study site
Wetumpka, Alabama
About this study
Official title: 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.
- Being tested
- Coaptite®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaptite®Device
Calcium hydroxylapatite particles suspended in an aqueous based gel carrier
| Study group | Role | What they receive |
|---|---|---|
| Coaptite | Experimental | Not described Receives: Device: Coaptite® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline up to Months 6 and 12
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Measured: Baseline up to Month 36
Secondary outcomes (7)
Number of Participants Who Received Each of the Six Coaptite Injections
Coaptite injection were given to any participant during the 36 months of evaluation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Months 6, 12, 18, 24, 30, and 36
Volume of Coaptite Injected Per Treatment
Measured: 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
Measured: Baseline, Baseline to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study start8 Jan 2008
- Primary completion26 Oct 2015
- Study completion2 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Female Stress Urinary Incontinence Due to Intrinsic Sphincter DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merz North America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996489
- Sponsor's protocol ID
- P1005185
- Status last verified
- Jan 2019
- First submitted
- 14 Oct 2009
- Last updated
- 23 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-approval of Coaptite® in the Treatment of Female Urinary Incontinence
- ClinicalTrials.gov ID
- NCT00996489
- Acronym / sponsor ID
- P1005185
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- Merz North America, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jan 2008 (actual)
- Primary completion
- 26 Oct 2015 (actual)
- Study completion
- 2 Nov 2015 (actual)
- First posted
- 16 Oct 2009 (estimated)
- Results
- Posted 23 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a post approval study of Coaptite® in the treatment of female urinary incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coaptite | Experimental | Device: Coaptite® |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coaptite®Calcium hydroxylapatite particles suspended in an aqueous based gel carrier | Device | Coaptite |
Primary outcome
Incontinence Status as Assessed by Stamey Grade Score
Time frame: Baseline and Months 6, 12, 18, 24, 30, and 36
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).
Number of Participants With One Point Improvement in Stamey Grade Scores up to Month 12
Time frame: Baseline 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).
Number of Participants Who Had at Least One Point Improvement in Stamey Grade Scores Compared to Baseline
Time frame: Months 6, 12, 18, 24, 30, and 36
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).
Number of Participants With Change From Baseline in Stamey Grade Scores Over Time
Time frame: Baseline up to Months 6 and 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).
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Time frame: Baseline up to Month 36
7 secondary outcomes
Number of Participants Who Received Each of the Six Coaptite Injections
Time frame: Baseline up to Month 36
Time to Coaptite Retreatment
Time frame: Baseline up to Month 36
Number of Participants With Alternative Treatments for Incontinence
Time frame: 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
Time frame: Baseline up to Month 36
Incontinence Quality of Life (iQoL) Scores
Time frame: Baseline and Months 6, 12, 18, 24, 30, and 36
Volume of Coaptite Injected Per Treatment
Time frame: 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
Time frame: Baseline, Baseline to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency
Recruiting
Adjustable Continence Therapy (ACT) for the Treatment of Female SUI
Urinary Incontinence, Urinary Incontinence,Stress
Not yet recruiting
Trial of NASHA Dx Urethral Bulking System
Urinary Incontinence, Urinary Incontinence (UI)
Not yet recruiting
Safety and Clinical Performance Study of the ARTUS® Artificial Urinary Sphincter (AUS)
Stress Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaptite® in people with Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency, run by Merz North America, Inc. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incontinence Status as Assessed by Stamey Grade Score (time frame: Baseline and Months 6, 12, 18, 24, 30, and 36). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.