Urinary Incontinence, Stress
Conditions
Keywords
Single Incision Sling
Brief summary
The purpose of this study is to monitor the use of Altis Single Incision Sling (SIS) in a real world population and collect medical data on effectiveness and to monitor safety of Altis SIS at 12 and 36 months post device implantation in women with stress urinary incontinence.
Detailed description
This project has been launched after the introduction of Altis in Europe. This study is a multicenter prospective, observational (i.e. naturalistic) post-marketing clinical follow-up of women for who stress urinary incontinence was diagnosed and will be treated with Altis Single Incision Sling System. Therefore these patients will be asked to allow to use their clinical data and answer some questionnaires. The patients'data will be collected in routine clinical practice before, during and after surgery until 12 months. Then, questionnaires will be mailed to the participants annually during 2 additional years.
Interventions
Minimally invasive system including permanently implantable synthetic suburethral sling for the surgical treatment of female Stress Urinary Incontinence
Sponsors
Coloplast A/S
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Implanted with Altis Single Incision Sling System
Exclusion criteria
* Refuses to be included in the survey or that their medical data will be used for research purposes * Indication for Altis Single Incision Sling System implantation is not for the treatment of female urinary incontinence.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success | 12 months | Treatment success is a composite criterion defined in the protocol as condition improvement by Patient Global Impression of Improvement (PGI-I) reported as "a little better", "much better" or "very much better" and absence of serious or severe related Adverse Events (AEs) one year after implantation. As this definition of success was not restrictive enough, the Scientific Committee proposed a new definition for the treatment success for the statistical analysis, which was defined by PGI-I reported as "very much better" or "much better" and absence of any severe or serious or grade ≥ III of the Clavien-Dindo classification related AEs one year after implantation. |
| Patient Global Impression of Improvement (PGI-I) | 12 months | PGI-I is one of the two outcome measures of the composite primary endpoint. It is a validated question that collects the patients' 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 describes "very much better" or "much better" or "little better" and the percentage of patients who describes "very much better" or "much better" were measured. |
| Related Adverse Events | 12 months | Related Adverse Events (AEs) are one of the two outcome measures of the composite primary endpoint. All AEs related or judged related to the procedure or the device were reported. The percentage of patients without any severe or serious related AEs and the percentage of patients without any severe or serious or grade ≥ III of the Clavien-Dindo classification related AEs were measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success | 8 weeks, 24, 36 months | Treatment success is a composite criterion defined in the protocol as condition improvement by Patient Global Impression of Improvement (PGI-I) reported as "a little better", "much better" or "very much better" and absence of serious or severe related adverse events one year after implantation. As this definition of success was not restrictive enough, the Scientific Committee proposed a new definition for the treatment success for the statistical analysis, which was defined by PGI-I reported as "very much better" or "much better" and absence of any severe or serious or grade ≥ III of the Clavien-Dindo classification related adverse event one year after implantation. |
| Cough Stress Test (CST) | Baseline, 8 weeks and 12 months | 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 negative test was calculated at baseline, at the post-operative visit and at one year. |
| Post-void Residual (PVR) Volume | Baseline, 8 weeks and 12 months | Post-void residual (PVR) volume was collected pre- and post implant procedure up to 12 months. If the PVR volume was considered normal by the physician after the procedure, it was not necessary to collect this data at the subsequent follow-up visits. |
| Pad Use | Baseline, 8 weeks, 12, 24 and 36 months | The number of pads used per patient per day was collected. Patients were considered to be pad free if they reported never wearing pads or wear pads just for a sense of security. |
| International Consultation on Incontinence Questionnaire (ICIQ-UI) | Baseline, 8 weeks, 12, 24 and 36 months | 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. |
| Subject Global Satisfaction Questionnaire | 8 weeks, 12, 24, 36 months | 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 measured the percentage of patients who were very satisfied and satisfied. The patients answer the question "Do you recommend this operation to a friend?" by "yes" or "no". We measured the percentage of patients who answered "yes". |
| Incontinence Quality of Life Questionnaire (I-QoL) | Baseline, 8 weeks, 12, 24, 36 months | 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 and its subcale scores are computed by adding each item response, 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). |
| Impact on Sexual Function Assessed by the Pelvic Organ/Urinary Incontinence Sexual Questionnaire (PISQ 12) | Baseline, 8 weeks, 12, 24, 36 months | 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 organ prolapse. Reponses are graded on a 5-point Likert scale from "never" to "always". The scores were calculated at each assessment visit. |
| Patient Global Impression of Improvement (PGI-I) | 8 weeks, 24, 36 months | PGI-I is a validated question that collects the patients' 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 describes "very much better" or "much better" or "little better" was measured. |
Countries
Belgium, France, Germany, Italy, Spain
Contacts
PRINCIPAL_INVESTIGATORGrégoire Capon, MD
CHU Pellegrin, Bordeaux, France
Participant flow
Recruitment details
The first patient was included on 23rd May 2015. The last inclusion occurred on 21st September 2020.
Pre-assignment details
598 subjects were enrolled but 34 subjects were excluded from analysis for the following reasons: 20 GCP compliance deviations, 13 screening failures and 1 implanted patient but whose procedure form was not captured in the eCRF.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 51.5 Years |
| Body Mass Index | 25.0 kg/m2 |
| Duration since urinary incontinence onset | 4.5 Years |
| Pure stress urinary incontinence | 399 Participants |
| Sex: Female, Male Female | 564 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 564 |
| other Total, other adverse events | 145 / 564 |
| serious Total, serious adverse events | 3 / 564 |
Outcome results
None listed