Urinary Incontinence, StressNCT04115605
A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence
An observational study of Urinary Incontinence, Stress, run by Coloplast A/S at 33 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence, Stress
- What is being tested?
- Altis Single Incision Sling
- Type of treatment
- Medical device
- How many people
- 598 participants
- Where
- 33 sitesin 5 countries
- Study dates
- 23 May 2015to 24 Jun 2022
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female implanted with Altis Single Incision Sling System to treat stress urinary incontinence
Who may be able to join
- Implanted with Altis Single Incision Sling System
Who cannot join
- 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.
Trial locations and contacts
33 sites in 5 countries.
33 sites in 5 countries
France24 sites
CHRU Hotel Dieu
Angers, 49933
Clinique Rhône Durance
Avignon, 84082
Clinique Champeau Mediterranée
Béziers, 34535
CHU Pellegrin-Urology Departement
Bordeaux, 33076
CHU Pellegrin_Gyneacology Departement
Bordeaux, 33076
Polyclinique Jean Villars
Bruges, 33523
Hôpital du Pays d'Autan
Castres, 81108
Pôle Santé Léonard de Vinci
Chambray-lès-Tours, 37170
CHU Clermont Ferrand
Clermont-Ferrand, 63003
Hôpital Victor Jousselin
Dreux, 28102
CH Paul Ardier
Issoire, 63503
Clinique Saint-Charles
La Roche-sur-Yon, 85106
Centre Hospitalier Saint Louis
La Rochelle, 17019
Clinique du Mail La Rochelle
La Rochelle, 17087
Clinique Saint-Amé
Lambres-lez-Douai, 59552
CH Libourne
Libourne, 33500
Clinique Mutualiste de la Porte de l'Orient
Lorient, 56100
Hôpital privé Jacques Cartier
Massy, 91349
Armand Brillart Hospital
Nogent-sur-Marne, 94130
CHI Poissy Saint Germain en Laye
Poissy, 78303
Clinique St Hilaire
Rouen, 76044
Centre Clinical
Soyaux, 16800
Clinique Saint Jean Languedoc
Toulouse, 31077
Clinique Ambroise Paré
Toulouse, 31082
Spain4 sites
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Univeritario Joan XXIII
Tarragona, 43005
Hospital la Fé
Valencia, 46026
Hosital Clinico de Valladolid
Valladolid, 47003
Germany3 sites
Frauenärzte im Seenland
Gunzenhausen, 91710
Klinikum Memmingen
Memmingen, 87700
Klinikum Worms gGmbH
Worms, 67550
About this study
Official title: A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence A Post-marketing and Multicenter Prospective Observational Cohort Study in Subjects With Female Stress Urinary Incontinence
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.
Read the 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.
- Conditions
- Urinary Incontinence, Stress
- Being tested
- Altis Single Incision Sling
- Keywords
- Single Incision Sling
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Altis Single Incision SlingDevice
Minimally invasive system including permanently implantable synthetic suburethral sling for the surgical treatment of female Stress Urinary Incontinence
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success
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.
Measured: 12 months
Patient Global Impression of Improvement (PGI-I)
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.
Measured: 12 months
Related Adverse Events
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.
Measured: 12 months
Secondary outcomes (9)
Treatment Success
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.
Measured: 8 weeks, 24, 36 months
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 negative test was calculated at baseline, at the post-operative visit and at one year.
Measured: Baseline, 8 weeks and 12 months
Post-void Residual (PVR) Volume
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.
Measured: Baseline, 8 weeks and 12 months
Pad Use
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.
Measured: Baseline, 8 weeks, 12, 24 and 36 months
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.
Measured: Baseline, 8 weeks, 12, 24 and 36 months
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 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".
Measured: 8 weeks, 12, 24, 36 months
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 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).
Measured: Baseline, 8 weeks, 12, 24, 36 months
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 organ prolapse. Reponses are graded on a 5-point Likert scale from "never" to "always". The scores were calculated at each assessment visit.
Measured: Baseline, 8 weeks, 12, 24, 36 months
Patient Global Impression of Improvement (PGI-I)
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.
Measured: 8 weeks, 24, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start23 May 2015
- Primary completion22 Sep 2021
- Study completion24 Jun 2022
Why it stopped: The minimum of enrolled subject defined in the protocol was 180 patients and it was greatly exceeded. Therefore the study was terminated by the sponsor to perform the study analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Incontinence, StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 598 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grégoire Capon, MD, Principal investigator, CHU Pellegrin, Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115605
- Sponsor's protocol ID
- SU017
- Status last verified
- May 2026
- First submitted
- 23 Jul 2015
- Last updated
- 26 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3 Years Naturalistic Cohort Survey of Altis Single Incision Sling System For Female Stress Urinary Incontinence A Post-marketing and Multicenter Prospective Observational Cohort Study in Subjects With Female Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT04115605
- Acronym / sponsor ID
- SU017
- Conditions
- Urinary Incontinence, Stress
- Keywords
- Single Incision Sling
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The minimum of enrolled subject defined in the protocol was 180 patients and it was greatly exceeded. Therefore the study was terminated by the sponsor to perform the study analysis.
- Enrolment
- 598 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 23 May 2015 (actual)
- Primary completion
- 22 Sep 2021 (actual)
- Study completion
- 24 Jun 2022 (actual)
- First posted
- 4 Oct 2019 (actual)
- Results
- Posted 26 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female implanted with Altis Single Incision Sling System to treat stress urinary incontinence
Key inclusion criteria (1 listed)
- Implanted with Altis Single Incision Sling System
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Altis Single Incision SlingMinimally invasive system including permanently implantable synthetic suburethral sling for the surgical treatment of female Stress Urinary Incontinence | Device | – |
Primary outcome
Treatment Success
Time frame: 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)
Time frame: 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
Time frame: 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.
9 secondary outcomes
Treatment Success
Time frame: 8 weeks, 24, 36 months
Cough Stress Test (CST)
Time frame: Baseline, 8 weeks and 12 months
Post-void Residual (PVR) Volume
Time frame: Baseline, 8 weeks and 12 months
Pad Use
Time frame: Baseline, 8 weeks, 12, 24 and 36 months
International Consultation on Incontinence Questionnaire (ICIQ-UI)
Time frame: Baseline, 8 weeks, 12, 24 and 36 months
Subject Global Satisfaction Questionnaire
Time frame: 8 weeks, 12, 24, 36 months
Incontinence Quality of Life Questionnaire (I-QoL)
Time frame: Baseline, 8 weeks, 12, 24, 36 months
Impact on Sexual Function Assessed by the Pelvic Organ/Urinary Incontinence Sexual Questionnaire (PISQ 12)
Time frame: Baseline, 8 weeks, 12, 24, 36 months
Patient Global Impression of Improvement (PGI-I)
Time frame: 8 weeks, 24, 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Urinary Incontinence, Stress
RecruitingPhase 3
A Study of Orforglipron in Female Participants With Stress Urinary Incontinence Who Have Obesity or Overweight
Urinary Incontinence,Stress
Active, not recruitingObservational study
Return to Physical Activity After Retropublic Transvaginal Sling and Laparoscopic Sacrocolpopexy
Stress Urinary Incontinence, Pelvic Organ Prolapse
RecruitingPhase 1
Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
Urinary Incontinence Stress
Recruiting
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy
Prostate Cancer (Post Prostatectomy)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grégoire Capon, MD principal investigator
CHU Pellegrin, Bordeaux, France
33 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Incontinence, Stress, run by Coloplast A/S at 33 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in France, Spain, Germany, Belgium, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Success (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.