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

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).

Time frame: Baseline and Months 6, 12, 18, 24, 30, and 36

Population: 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.

Time frame: Baseline up to Month 36

Population: The SES was the subset of all participants enrolled who were exposed to the study device at least once.

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).

Time frame: Months 6, 12, 18, 24, 30, and 36

Population: 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).

Time frame: Baseline up to Months 6 and 12

Population: 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).

Time frame: Baseline up to Month 12

Population: 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 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.

Time frame: Baseline and Months 6, 12, 18, 24, 30, and 36

Population: 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 frame: Baseline, Baseline to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36

Population: 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.

Coaptite injection were given to any participant during the 36 months of evaluation.

Time frame: Baseline up to Month 36

Population: The FAS consisted of SES participants who had a baseline and at least one post-baseline observed or imputed primary effectiveness value.

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.

Time frame: Baseline up to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36

Population: The SES was the subset of all participants enrolled who were exposed to the study device at least once.

The use of urge incontinence medications was collected pre-treatment and post-treatment.

Time frame: Baseline up to Month 36

Population: 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.

Time frame: Baseline up to Month 36

Population: 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 frame: Baseline, Baseline to Month 6 and Months 6 to 12, 12 to 18, 18 to 24, 24 to 30, 30 to 36

Population: 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.