Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Patient Global Impression of Improvement (PGI-I) |
PGI-I is a validated question that collects the patient's impression of improvement after the surgery. Among this 7 point-scale (very much better, much better, a little better, no change, a little worse, much worse and very much worse), the patients are asked to check the one number that describes how their urinay tract condition is now, compared with how it's was before the surgery. Patients who score little or much or very much better without serious or severe related adverse events will be considered a treatment success. The percentage of patients who describe the treatment success is measured |
12 months |
|
| Primary |
Adverse events |
Adverse events are any toward medical occurrence, unintended disease or injury or any untoward clinical signs in subjects. Adverse events will be categorized according to relatedness to device or procedure, severity and frequency. At 12-months, The percentage of patients without any device related severe or serious adverse events is measured. |
12 months |
|
| Secondary |
Cough stress test (CST) |
CST provides the means for documenting stress urinary incontinence. CST is considered "positive" if any leakage is noted with cough or valsava. The percentage of patients with positive and negative test will be calculated at baseline, at the post-operative visit and at one year |
Baseline, 8 weeks and 12 months |
|
| Secondary |
Post-void residual (PVR) volume |
PVR volume will be collected pre- and post implant procedure up to 12 months. If the PVR volume is considered normal by the physician after the procedure it is not necessary to collect these data at the subsequent follow-up visits. |
Baseline, 8 weeks and 12 months |
|
| Secondary |
Pad Use |
The number of pads used will be collected. Patients will be considered to be pad free if they report never wearing pads or wear pads just for a sense of security. |
Baseline, 8 weeks, 12, 24 and 36 months |
|
| Secondary |
International Consultation on Incontinence Questionnaire (ICIQ-UI) |
The ICIQ-UI Short Form is a seft-administred questionnaire to evaluate the frequency, severity and impact on quality of life of urinary incontinence. Question 1 asked, "How often do you leak urine?" Subjects were instructed to select among "none" (0), "about once a week or less often" (1), "2 or 3 times a week" (2), "about once a day" (3), "several times a day" (4), and "all the time" (5). Question 2 asked, "How much urine do you usually leak (whether you wear protection or not)?" Patients responded with "none" (0), "a small amount" (2), "a moderate amount" (4) or "a large amount (6). Question 3 asked, "Overall, how much does leaking urine interfere with your everyday life?" Participants chose a number from 0 (not at all) to 10 (a great deal). Question 1, 2 and 3 are summed to compute the total ICIQ score.The total score range is then a minimum of 0 to a maximum of 21. The mean score, aboslute and relative change compared to baseline will be measure |
Baseline, 8 weeks, 12, 24 and 36 months |
|
| Secondary |
Subject global satisfaction questionnaire |
This non-validated questionnaire provides additional information concerning patient satisfaction. This survey consists of two questions: Question 1 "how satisfied are you with your surgery?". Among 5 point-scale (very satisfied, satisfied, not satisfied-not dissatisfied, dissatisfied and very dissatified), patient check the one items that best describes the subject satisfaction. We measure the percentage the patients who very satisfied and satisfied. The patients answer the question "Do you recommend this operation to a friend?" by "yes" or "no". We measure the percentage of patients who answer "yes". |
8 weeks, 12, 24, 36 months |
|
| Secondary |
Incontinence quality of life questionnaire (I-QoL) |
The Incontinence quality of life questionnaire (I-QoL) is a validated survey questionnaire with 22 items that are scored on a 5-point Likert scale. The I-QOL ans its subcale scores are computed by adding each item's reponse, subtracting the lowest possible score and diving that sum by the possible raw score range. The scores are then transformed to have a range from 0 (maximum problem) to 100 (no problem at all). The mean score, absolute and relative change compared to baseline |
Baseline, 8 weeks, 12, 24, 36 months |
|
| Secondary |
Impact on sexual function assessed by the Pelvic organ/urinary incontinence sexual questionnaire (PISQ 12) |
The Pelvic organ/urinary incontinence sexual questionnaire (PISQ-12) is a validated and reliable short form questionnaire including 12 questions that evaluates sexual function in heterosexual women with urinary incontinence and/or pelvic oragn prolapse. Reponses are graded on a 5-point Likert scale from "never" to "always". The scores will be calculated at each assessment visit. The mean score, absolute and relative change compared to baseline |
Baseline, 8 weeks, 12, 24, 36 months |
|
| Secondary |
Patient Global Impression of Improvement (PGI-I) |
PGI-I is a validated question that collects the patient's impression of improvement after the surgery. Among this 7 point-scale (very much better, much better, a little better, no change, a little worse, much worse and very much worse), the patients are asked to check the one number that describes how their urinay tract condition is now, compared with how it's was before the surgery. The percentage of patients who describe very much better or much better or little better is measured |
8 weeks, 24, 36 months |
|
| Secondary |
Adverse events |
Adverse events are any toward medical occurrence, unintended disease or injury or any untoward clinical signs in subjects. Adverse events will be categorized according to relatedness to device or procedure, severity and frequency. The percentage of patients without any device related severe or serious adverse events is measured. |
8 weeks, 24, 36 months |
|
