Trial Outcomes & Findings for This is a Post Approval Study of Coaptite® in the Treatment of Female Urinary Incontinence (NCT NCT00996489)
NCT ID: NCT00996489
Last Updated: 2019-07-23
Results Overview
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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
459 participants
Primary outcome timeframe
Months 6, 12, 18, 24, 30, and 36
Results posted on
2019-07-23
Participant Flow
The study was conducted at 20 sites in the United States.
A total of 459 participants were screened, enrolled and treated in the study. Of these, 298 participants completed the 36-month study.
Participant milestones
| Measure |
Coaptite
Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
|
|---|---|
|
Overall Study
STARTED
|
459
|
|
Overall Study
COMPLETED
|
298
|
|
Overall Study
NOT COMPLETED
|
161
|
Reasons for withdrawal
| Measure |
Coaptite
Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
|
|---|---|
|
Overall Study
Device failure
|
45
|
|
Overall Study
Discontinued
|
116
|
Baseline Characteristics
This is a Post Approval Study of Coaptite® in the Treatment of Female Urinary Incontinence
Baseline characteristics by cohort
| Measure |
Coaptite
n=459 Participants
Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
|
|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 12.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
459 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
9 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black
|
8 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
406 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
33 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
459 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and Months 6, 12, 18, 24, 30, and 36Population: The full analysis set (FAS) consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value. Participants who were evaluable for this measure at given time period for the arm were included in the category.
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).
Outcome measures
| Measure |
Coaptite
n=458 Participants
Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
|
|---|---|
|
Incontinence Status as Assessed by Stamey Grade Score
Baseline
|
2.5 score on a scale
Standard Deviation 0.7
|
|
Incontinence Status as Assessed by Stamey Grade Score
Month 6
|
1.6 score on a scale
Standard Deviation 1.1
|
|
Incontinence Status as Assessed by Stamey Grade Score
Month 12
|
1.5 score on a scale
Standard Deviation 1.2
|
|
Incontinence Status as Assessed by Stamey Grade Score
Month 18
|
1.6 score on a scale
Standard Deviation 1.2
|
|
Incontinence Status as Assessed by Stamey Grade Score
Month 24
|
1.5 score on a scale
Standard Deviation 1.2
|
|
Incontinence Status as Assessed by Stamey Grade Score
Month 30
|
1.5 score on a scale
Standard Deviation 1.2
|
|
Incontinence Status as Assessed by Stamey Grade Score
Month 36
|
1.5 score on a scale
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: Baseline up to Month 12Population: The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value. The FAS, where 6 and 12 months follow up data for the participants was available.
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).
Outcome measures
| Measure |
Coaptite
n=382 Participants
Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
|
|---|---|
|
Number of Participants With One Point Improvement in Stamey Grade Scores up to Month 12
|
171 participants
|
PRIMARY outcome
Timeframe: Months 6, 12, 18, 24, 30, and 36Population: The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value. Participants who were evaluable for this measure at given time period for the arm were included in the category.
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).
Outcome measures
| Measure |
Coaptite
n=458 Participants
Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
|
|---|---|
|
Number of Participants Who Had at Least One Point Improvement in Stamey Grade Scores Compared to Baseline
Month 6
|
229 participants
|
|
Number of Participants Who Had at Least One Point Improvement in Stamey Grade Scores Compared to Baseline
Month 12
|
234 participants
|
|
Number of Participants Who Had at Least One Point Improvement in Stamey Grade Scores Compared to Baseline
Month 18
|
208 participants
|
|
Number of Participants Who Had at Least One Point Improvement in Stamey Grade Scores Compared to Baseline
Month 24
|
221 participants
|
|
Number of Participants Who Had at Least One Point Improvement in Stamey Grade Scores Compared to Baseline
Month 30
|
200 participants
|
|
Number of Participants Who Had at Least One Point Improvement in Stamey Grade Scores Compared to Baseline
Month 36
|
199 participants
|
PRIMARY outcome
Timeframe: Baseline up to Months 6 and 12Population: The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value.
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).
Outcome measures
| Measure |
Coaptite
n=458 Participants
Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
|
|---|---|
|
Number of Participants With Change From Baseline in Stamey Grade Scores Over Time
Month 6
|
408 participants
|
|
Number of Participants With Change From Baseline in Stamey Grade Scores Over Time
Month 12
|
391 participants
|
PRIMARY outcome
Timeframe: Baseline up to Month 36Population: The SES was the subset of all participants enrolled who were exposed to the study device at least once.
Outcome measures
| Measure |
Coaptite
n=459 Participants
Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
|
|---|---|
|
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
|
313 participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 36Population: The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value.
Coaptite injection were given to any participant during the 36 months of evaluation.
Outcome measures
| Measure |
Coaptite
n=458 Participants
Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
|
|---|---|
|
Number of Participants Who Received Each of the Six Coaptite Injections
Received First Injection
|
458 participants
|
|
Number of Participants Who Received Each of the Six Coaptite Injections
Received Second Injection
|
262 participants
|
|
Number of Participants Who Received Each of the Six Coaptite Injections
Received Third Injection
|
90 participants
|
|
Number of Participants Who Received Each of the Six Coaptite Injections
Received Fourth Injection
|
26 participants
|
|
Number of Participants Who Received Each of the Six Coaptite Injections
Received Fifth Injection
|
7 participants
|
|
Number of Participants Who Received Each of the Six Coaptite Injections
Received Sixth Injection
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 36Population: The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value. Participants who were evaluable for this measure at given time period for the arm were included in the category.
Time to additional coaptite treatment or any other alternative treatment for stress urinary incontinence was recorded to assess the durability of effect.
Outcome measures
| Measure |
Coaptite
n=458 Participants
Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
|
|---|---|
|
Time to Coaptite Retreatment
Injection 2 to 3
|
212 days
Standard Deviation 215.3
|
|
Time to Coaptite Retreatment
Injection 1 to 2
|
150.1 days
Standard Deviation 189.6
|
|
Time to Coaptite Retreatment
Injection 3 to 4
|
227.1 days
Standard Deviation 222.1
|
|
Time to Coaptite Retreatment
Injection 4 to 5
|
164 days
Standard Deviation 74.0
|
|
Time to Coaptite Retreatment
Injection 5 to 6
|
105 days
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
SECONDARY outcome
Timeframe: Baseline up to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36Population: The SES was the subset of all participants enrolled who were exposed to the study device at least once.
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.
Outcome measures
| Measure |
Coaptite
n=459 Participants
Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
|
|---|---|
|
Number of Participants With Alternative Treatments for Incontinence
Kegel Exercises: Month 0-6
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Kegel Exercises: Month 6-12
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Kegel Exercises: Month 12-18
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Kegel Exercises: Month 18-24
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Kegel Exercises: Month 24-30
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Kegel Exercises: Month 30-36
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Sling: Month 0-6
|
5 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Sling: Month 6-12
|
2 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Sling: Month 12-18
|
4 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Sling: Month 18-24
|
8 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Sling: Month 24-30
|
5 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Sling: Month 30-36
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Sling/Cystocele Repair: Month 0-6
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Sling/Cystocele Repair: Month 6-12
|
3 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Sling/Cystocele Repair: Month 12-18
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Sling/Cystocele Repair: Month 18-24
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Sling/Cystocele Repair: Month 24-30
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Sling/Cystocele Repair: Month 30-36
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Surgery: Month 0-6
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Surgery : Month 6-12
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Surgery: Month 12-18
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Surgery: Month 18-24
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Surgery: Month 24-30
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Surgery: Month 30-36
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Permanent Abdominal Tube: Month 0-6
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Permanent Abdominal Tube: Month 6-12
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Permanent Abdominal Tube: Month 12-18
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Permanent Abdominal Tube: Month 18-24
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Permanent Abdominal Tube: Month 24-30
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Permanent Abdominal Tube: Month 30-36
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Intravesical Botox: Month 0-6
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Intravesical Botox: Month 6-12
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Intravesical Botox: Month 12-18
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Intravesical Botox: Month 18-24
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Intravesical Botox: Month 24-30
|
2 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Intravesical Botox: Month 30-36
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Sling/Graft, Sling Removal: Month 0-6
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Sling/Graft, Sling Removal: Month 6-12
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Sling/Graft, Sling Removal: Month 12-18
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Sling/Graft, Sling Removal: Month 18-24
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Sling/Graft, Sling Removal: Month 24-30
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Sling/Graft, Sling Removal: Month 30-36
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Estradiol Vaginal Cream: Month 0-6
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Estradiol Vaginal Cream: Month 6-12
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Estradiol Vaginal Cream: Month 12-18
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Estradiol Vaginal Cream: Month 18-24
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Estradiol Vaginal Cream: Month 24-30
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Estradiol Vaginal Cream: Month 30-36
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Bladder Neck Suspension: Month 0-6
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Bladder Neck Suspension: Month 6-12
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Bladder Neck Suspension: Month 12-18
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Bladder Neck Suspension: Month 18-24
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Bladder Neck Suspension: Month 24-30
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Bladder Neck Suspension: Month 30-36
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Tension Free Vaginal Tape: Month 0-6
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Tension Free Vaginal Tape: Month 6-12
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Tension Free Vaginal Tape: Month 12-18
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Tension Free Vaginal Tape: Month 18-24
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Tension Free Vaginal Tape: Month 24-30
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Tension Free Vaginal Tape: Month 30-36
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Biofeedback: Month 0-6
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Biofeedback: Month 6-12
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Biofeedback: Month 12-18
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Biofeedback: Month 18-24
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Biofeedback: Month 24-30
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Biofeedback: Month 30-36
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Polydimethylsiloxane Injections: Month 0-6
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Polydimethylsiloxane Injections: Month 6-12
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Polydimethylsiloxane Injections: Month 12-18
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Polydimethylsiloxane Injections: Month 18-24
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Polydimethylsiloxane Injections: Month 24-30
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Polydimethylsiloxane Injections: Month 30-36
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Solifenacin orally: Month 0-6
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Solifenacin orally: Month 6-12
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Solifenacin orally: Month 12-18
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Solifenacin orally: Month 18-24
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Solifenacin orally: Month 24-30
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Solifenacin orally: Month 30-36
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
Bladder SpecificControlPhysical TherapyX6:0-6
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
BladderSpecificControlPhysicalTherapyX6:Month6-12
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
BladderSpecificControlPhysicalTherapyX6:Month12-18
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
BladderSpecificControlPhysicalTherapyX6:Month18-24
|
0 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
BladderSpecificControlPhysicalTherapyX6:Month24-30
|
1 participants
|
|
Number of Participants With Alternative Treatments for Incontinence
BladderSpecificControlPhysicalTherapyX6:Month
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline up to Month 36Population: The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value. Participants who were evaluable for this measure at given time period for the arm were included in the category.
The use of urge incontinence medications was collected pre-treatment and post-treatment.
Outcome measures
| Measure |
Coaptite
n=427 Participants
Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
|
|---|---|
|
Number of Participants With Urge Incontinence Medication (UIM) Status
|
52 participants
|
SECONDARY outcome
Timeframe: Baseline and Months 6, 12, 18, 24, 30, and 36Population: The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value. Participants who were evaluable for this measure at given time period for the arm were included in the category.
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.
Outcome measures
| Measure |
Coaptite
n=458 Participants
Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
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Incontinence Quality of Life (iQoL) Scores
Baseline
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39.5 units on a scale
Standard Deviation 21.9
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Incontinence Quality of Life (iQoL) Scores
Month 6
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69.6 units on a scale
Standard Deviation 24.5
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Incontinence Quality of Life (iQoL) Scores
Month 12
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70.3 units on a scale
Standard Deviation 24.5
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Incontinence Quality of Life (iQoL) Scores
Month 18
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70.4 units on a scale
Standard Deviation 24.4
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Incontinence Quality of Life (iQoL) Scores
Month 24
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71.2 units on a scale
Standard Deviation 24.3
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Incontinence Quality of Life (iQoL) Scores
Month 30
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73.5 units on a scale
Standard Deviation 24.3
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Incontinence Quality of Life (iQoL) Scores
Month 36
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72.7 units on a scale
Standard Deviation 24.4
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SECONDARY outcome
Timeframe: Baseline, Baseline to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36Population: The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value. Participants who were evaluable for this measure at given time period for the arm were included in the category.
Outcome measures
| Measure |
Coaptite
n=458 Participants
Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
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Volume of Coaptite Injected Per Treatment
Baseline
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1.8 milliliter (mL)
Standard Deviation 0.7
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Volume of Coaptite Injected Per Treatment
Baseline to Month 6
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1.8 milliliter (mL)
Standard Deviation 0.8
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Volume of Coaptite Injected Per Treatment
Month 6 to 12
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1.5 milliliter (mL)
Standard Deviation 0.6
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Volume of Coaptite Injected Per Treatment
Month 12 to 18
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2.0 milliliter (mL)
Standard Deviation 0.7
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Volume of Coaptite Injected Per Treatment
Month 18 to 24
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1.7 milliliter (mL)
Standard Deviation 0.8
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Volume of Coaptite Injected Per Treatment
Month 24 to 30
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1.7 milliliter (mL)
Standard Deviation 0.8
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Volume of Coaptite Injected Per Treatment
Month 30 to 36
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1.6 milliliter (mL)
Standard Deviation 1.3
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SECONDARY outcome
Timeframe: Baseline, Baseline to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36Population: The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value. Participants who were evaluable for this measure at given time period for the arm were included in the category.
Outcome measures
| Measure |
Coaptite
n=458 Participants
Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
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Mean Number of Sites Injected by Coaptite
Baseline
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2.4 number of sites
Standard Deviation 0.9
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Mean Number of Sites Injected by Coaptite
Baseline to Month 6
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2.4 number of sites
Standard Deviation 0.9
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Mean Number of Sites Injected by Coaptite
Month 6 to 12
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2.5 number of sites
Standard Deviation 0.9
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Mean Number of Sites Injected by Coaptite
Month 12 to 18
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2.6 number of sites
Standard Deviation 1.0
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Mean Number of Sites Injected by Coaptite
Month 18 to 24
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2.5 number of sites
Standard Deviation 1.0
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Mean Number of Sites Injected by Coaptite
Month 24 to 30
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2.9 number of sites
Standard Deviation 1.8
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Mean Number of Sites Injected by Coaptite
Month 30 to 36
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2.1 number of sites
Standard Deviation 0.3
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Adverse Events
Coaptite
Serious events: 163 serious events
Other events: 246 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Coaptite
n=459 participants at risk
Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
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Infections and infestations
Urinary tract infection
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24.8%
114/459 • Baseline up to Month 36
While the CRF was not designed to capture Serious Adverse Events (SAEs), following review of the safety data, Merz reported serious medical device reports (MDRs) to the FDA for 163 subjects and as a result, a subset of adverse events (AEs) originally classified as Other AEs were re-classified as SAEs. In some cases, the same adverse event term could correspond to either a serious or non-serious adverse event depending on the presence or absence of associated serious medical device report.
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Infections and infestations
Fungal infection
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1.1%
5/459 • Baseline up to Month 36
While the CRF was not designed to capture Serious Adverse Events (SAEs), following review of the safety data, Merz reported serious medical device reports (MDRs) to the FDA for 163 subjects and as a result, a subset of adverse events (AEs) originally classified as Other AEs were re-classified as SAEs. In some cases, the same adverse event term could correspond to either a serious or non-serious adverse event depending on the presence or absence of associated serious medical device report.
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Infections and infestations
Cystitis
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0.87%
4/459 • Baseline up to Month 36
While the CRF was not designed to capture Serious Adverse Events (SAEs), following review of the safety data, Merz reported serious medical device reports (MDRs) to the FDA for 163 subjects and as a result, a subset of adverse events (AEs) originally classified as Other AEs were re-classified as SAEs. In some cases, the same adverse event term could correspond to either a serious or non-serious adverse event depending on the presence or absence of associated serious medical device report.
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Infections and infestations
Vulvovaginal mycotic infection
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0.44%
2/459 • Baseline up to Month 36
While the CRF was not designed to capture Serious Adverse Events (SAEs), following review of the safety data, Merz reported serious medical device reports (MDRs) to the FDA for 163 subjects and as a result, a subset of adverse events (AEs) originally classified as Other AEs were re-classified as SAEs. In some cases, the same adverse event term could correspond to either a serious or non-serious adverse event depending on the presence or absence of associated serious medical device report.
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Renal and urinary disorders
Urinary retention
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13.7%
63/459 • Baseline up to Month 36
While the CRF was not designed to capture Serious Adverse Events (SAEs), following review of the safety data, Merz reported serious medical device reports (MDRs) to the FDA for 163 subjects and as a result, a subset of adverse events (AEs) originally classified as Other AEs were re-classified as SAEs. In some cases, the same adverse event term could correspond to either a serious or non-serious adverse event depending on the presence or absence of associated serious medical device report.
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Renal and urinary disorders
Urge incontinence
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5.9%
27/459 • Baseline up to Month 36
While the CRF was not designed to capture Serious Adverse Events (SAEs), following review of the safety data, Merz reported serious medical device reports (MDRs) to the FDA for 163 subjects and as a result, a subset of adverse events (AEs) originally classified as Other AEs were re-classified as SAEs. In some cases, the same adverse event term could correspond to either a serious or non-serious adverse event depending on the presence or absence of associated serious medical device report.
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Renal and urinary disorders
Micturition urgency
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0.87%
4/459 • Baseline up to Month 36
While the CRF was not designed to capture Serious Adverse Events (SAEs), following review of the safety data, Merz reported serious medical device reports (MDRs) to the FDA for 163 subjects and as a result, a subset of adverse events (AEs) originally classified as Other AEs were re-classified as SAEs. In some cases, the same adverse event term could correspond to either a serious or non-serious adverse event depending on the presence or absence of associated serious medical device report.
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Renal and urinary disorders
Pollakiuria
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0.87%
4/459 • Baseline up to Month 36
While the CRF was not designed to capture Serious Adverse Events (SAEs), following review of the safety data, Merz reported serious medical device reports (MDRs) to the FDA for 163 subjects and as a result, a subset of adverse events (AEs) originally classified as Other AEs were re-classified as SAEs. In some cases, the same adverse event term could correspond to either a serious or non-serious adverse event depending on the presence or absence of associated serious medical device report.
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Renal and urinary disorders
Haematuria
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0.65%
3/459 • Baseline up to Month 36
While the CRF was not designed to capture Serious Adverse Events (SAEs), following review of the safety data, Merz reported serious medical device reports (MDRs) to the FDA for 163 subjects and as a result, a subset of adverse events (AEs) originally classified as Other AEs were re-classified as SAEs. In some cases, the same adverse event term could correspond to either a serious or non-serious adverse event depending on the presence or absence of associated serious medical device report.
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Renal and urinary disorders
Nocturia
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0.44%
2/459 • Baseline up to Month 36
While the CRF was not designed to capture Serious Adverse Events (SAEs), following review of the safety data, Merz reported serious medical device reports (MDRs) to the FDA for 163 subjects and as a result, a subset of adverse events (AEs) originally classified as Other AEs were re-classified as SAEs. In some cases, the same adverse event term could correspond to either a serious or non-serious adverse event depending on the presence or absence of associated serious medical device report.
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Renal and urinary disorders
Urethritis noninfective
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0.44%
2/459 • Baseline up to Month 36
While the CRF was not designed to capture Serious Adverse Events (SAEs), following review of the safety data, Merz reported serious medical device reports (MDRs) to the FDA for 163 subjects and as a result, a subset of adverse events (AEs) originally classified as Other AEs were re-classified as SAEs. In some cases, the same adverse event term could correspond to either a serious or non-serious adverse event depending on the presence or absence of associated serious medical device report.
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Renal and urinary disorders
Haemorrhage urinary tract
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0.22%
1/459 • Baseline up to Month 36
While the CRF was not designed to capture Serious Adverse Events (SAEs), following review of the safety data, Merz reported serious medical device reports (MDRs) to the FDA for 163 subjects and as a result, a subset of adverse events (AEs) originally classified as Other AEs were re-classified as SAEs. In some cases, the same adverse event term could correspond to either a serious or non-serious adverse event depending on the presence or absence of associated serious medical device report.
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Reproductive system and breast disorders
Cystocele
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0.44%
2/459 • Baseline up to Month 36
While the CRF was not designed to capture Serious Adverse Events (SAEs), following review of the safety data, Merz reported serious medical device reports (MDRs) to the FDA for 163 subjects and as a result, a subset of adverse events (AEs) originally classified as Other AEs were re-classified as SAEs. In some cases, the same adverse event term could correspond to either a serious or non-serious adverse event depending on the presence or absence of associated serious medical device report.
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Vascular disorders
Haemorrhage
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0.22%
1/459 • Baseline up to Month 36
While the CRF was not designed to capture Serious Adverse Events (SAEs), following review of the safety data, Merz reported serious medical device reports (MDRs) to the FDA for 163 subjects and as a result, a subset of adverse events (AEs) originally classified as Other AEs were re-classified as SAEs. In some cases, the same adverse event term could correspond to either a serious or non-serious adverse event depending on the presence or absence of associated serious medical device report.
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Other adverse events
| Measure |
Coaptite
n=459 participants at risk
Participants received first coaptite injection of calcium hydroxylapatite particles suspended in an aqueous based gel carrier, at baseline visit (Month 0) within 60 days of pad weight confirmation and the dosage was decided by the physician which was required to bulk the urethra to achieve the clinically desired level of incontinence correction. If an additional injection was determined to be clinically necessary, based on investigator's clinical judgement, participants received additional coaptite injections during 36 months.
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Infections and infestations
Urinary tract infection
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29.6%
136/459 • Baseline up to Month 36
While the CRF was not designed to capture Serious Adverse Events (SAEs), following review of the safety data, Merz reported serious medical device reports (MDRs) to the FDA for 163 subjects and as a result, a subset of adverse events (AEs) originally classified as Other AEs were re-classified as SAEs. In some cases, the same adverse event term could correspond to either a serious or non-serious adverse event depending on the presence or absence of associated serious medical device report.
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Renal and urinary disorders
Micturition urgency
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6.3%
29/459 • Baseline up to Month 36
While the CRF was not designed to capture Serious Adverse Events (SAEs), following review of the safety data, Merz reported serious medical device reports (MDRs) to the FDA for 163 subjects and as a result, a subset of adverse events (AEs) originally classified as Other AEs were re-classified as SAEs. In some cases, the same adverse event term could correspond to either a serious or non-serious adverse event depending on the presence or absence of associated serious medical device report.
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Renal and urinary disorders
Urge incontinence
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23.7%
109/459 • Baseline up to Month 36
While the CRF was not designed to capture Serious Adverse Events (SAEs), following review of the safety data, Merz reported serious medical device reports (MDRs) to the FDA for 163 subjects and as a result, a subset of adverse events (AEs) originally classified as Other AEs were re-classified as SAEs. In some cases, the same adverse event term could correspond to either a serious or non-serious adverse event depending on the presence or absence of associated serious medical device report.
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Renal and urinary disorders
Urinary retention
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14.4%
66/459 • Baseline up to Month 36
While the CRF was not designed to capture Serious Adverse Events (SAEs), following review of the safety data, Merz reported serious medical device reports (MDRs) to the FDA for 163 subjects and as a result, a subset of adverse events (AEs) originally classified as Other AEs were re-classified as SAEs. In some cases, the same adverse event term could correspond to either a serious or non-serious adverse event depending on the presence or absence of associated serious medical device report.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
- Publication restrictions are in place
Restriction type: OTHER