| Primary | 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). | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline and Months 6, 12, 18, 24, 30, and 36 | | | | ID | Title | Description |
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| OG000 | 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. |
| | | Title | Denominators | Categories |
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| Baseline | | | | Month 6 | |
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| Primary | 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). | 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. | Posted | | Number | | participants | | Baseline up to Month 12 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Primary | 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). | 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. | Posted | | Number | | participants | | Months 6, 12, 18, 24, 30, and 36 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Primary | 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). | The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value. | Posted | | Number | | participants | | Baseline up to Months 6 and 12 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Primary | Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) | | The SES was the subset of all participants enrolled who were exposed to the study device at least once. | Posted | | Number | | participants | | Baseline up to Month 36 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Participants Who Received Each of the Six Coaptite Injections | Coaptite injection were given to any participant during the 36 months of evaluation. | The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value. | Posted | | Number | | participants | | Baseline up to Month 36 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | days | | Baseline up to Month 36 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | 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. | The SES was the subset of all participants enrolled who were exposed to the study device at least once. | Posted | | Number | | participants | | Baseline up to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Number of Participants With Urge Incontinence Medication (UIM) Status | The use of urge incontinence medications was collected pre-treatment and post-treatment. | 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. | Posted | | Number | | participants | | Baseline up to Month 36 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | 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. | 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. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Months 6, 12, 18, 24, 30, and 36 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Volume of Coaptite Injected Per Treatment | | 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. | Posted | | Mean | Standard Deviation | milliliter (mL) | | Baseline, Baseline to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Mean Number of Sites Injected by Coaptite | | 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. | Posted | | Mean | Standard Deviation | number of sites | | Baseline, Baseline to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36 | | | | ID | Title | Description |
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| OG000 | 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. |
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