Stress Urinary IncontinenceEASYNCT02049840
The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence
A study testing Altis Single Incision Sling System in people with Stress Urinary Incontinence, run by Coloplast A/S at 13 sites in 5 countries.
Trial summary
This is a prospective, post-market, single arm, multicenter study comparing Baseline data to the 12 month and 36 month data in 136 female patients 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
- Stress Urinary Incontinence
- What is being tested?
- Altis Single Incision Sling System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 13 sitesin 5 countries
- Study dates
- 16 Dec 2013to 21 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- The subject is female at least 18 years of age
- The subject uses a method of contraception considered effective by the investigator or is not of child-bearing potential
- The subject is able and willing to complete all procedures and follow-up visits indicated in this protocol.
- The subject has confirmed stress urinary incontinence (SUI) through cough stress test at baseline.
- The subject has failed first line treatments (non-invasive therapies, eg. behavioral modification, Pelvic Floor/Kegel exercises, or biofeedback) with good compliance for the treatment
Who cannot join
- The subject had a prior surgical SUI treatment (including bulking agent).
- The subject is having a concomitant Pelvic Organ Prolapse repair or hysterectomy during Altis procedure.
- The subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions).
- The subject has predominant or uncontrolled or primary urge incontinence according to investigator judgment
- The patient has detrusor overactivity determined through urodynamics
- The subject has intrinsic sphincter deficiency defined urodynamically as a Maximal Urethral Closure Pressure < 20 cm H2O and/or Valsalva Leak Point Pressure < 60 cm H2O
Show all 16Show fewer
- The subject has atonic bladder, a persistent post void residual (PVR) > 100 ml or chronic urinary retention.
- The subject has untreated urinary malignancy
- The subject has undergone radiation or brachy therapy or chemotherapy to treat pelvic cancer.
- The subject has urethrovaginal fistula or urethral diverticulum or congenital urinary anomalies
- The subject has serious bleeding disorder or requires anticoagulant therapy
- The subject is pregnant and/or is planning to get pregnant in the future.
- The subject has a Body Mass Index ≥ 35 (obese class II).
- The subject has a contraindication to the surgical procedure according to the the Altis SIS System IFU.
- The subject has an active urogenital infection or active skin infection in region of surgery mainly at the time of implantation.
- The subject is enrolled in a concomitant clinical trial.
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
France6 sites
Hôpital Femme Mère Enfant
Bron, 69677
Hôpital de la Conception
Marseille, 13005
Centre Hospitalier Universitaire Carémeau - Gyneacology
Nîmes, 30029
Centre Hospitalier Universitaire Carémeau
Nîmes, 30029
Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle
Rouen, 76031
Nouvel Hôpital Civil
Strasbourg, 67091
Spain3 sites
Hospital Universitario La Ribera
Alzira, Valencia, 46600
Fundacion Jimenez Diaz
Madrid, 28040
Hospital de Sagunto
Sagunto, Valencia, 46520
Germany2 sites
Isarklinikum
München, 80331
Chirurgische Klinik München - Bogenhausen GmbH
München, 81679
About this study
This is a prospective, post-market, single arm, multicenter study comparing Baseline data to the 12 month and 36 month data in 136 female patients with Stress Urinary Incontinence
Read the detailed description
This study is a prospective, European Post-Market, one non-controlled arm, multi-centre clinical trial conducted at up to 10 centers in Europe. It is designed to get more clinical information for users (uro-gynecologists) of the Altis Single Incision Sling System for female stress urinary incontinence treatment in terms of objective and subjective cure rate, quality of life improvement, patient satisfaction and safety, especially in long term follow-up (3 years). Clinical data will be collected at baseline, implantation procedure, post-operative at 6 weeks, 6 months, 1, 2 and 3 years
- Conditions
- Stress Urinary Incontinence
- Being tested
- Altis Single Incision Sling System
- Keywords
- Female sling, Stress Urinary Incontinence, Urination Disorders, Urologic Diseases
- Medical subject headings
- Urinary Incontinence, Stress, Urination Disorders, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Altis Single Incision Sling SystemDevice
Altis Single Incision Sling (SIS) System is a permanently implantable synthetic sling for the surgical treatment of Stress Urinary Incontinence
| Study group | Role | What they receive |
|---|---|---|
| Altis Single Incision Sling System | Experimental | Altis Single Incision Sling System Receives: Device: Altis Single Incision Sling System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who meet the criteria of cure at 12 months
Cure is defined as negative Cough Stress Test (CST) and an answer "no" to question 3 "Do you usually experience urine leakage related to coughing, sneezing, or laughing?" of the UDI-6 questionnaire
Measured: 1 year
Secondary outcomes (10)
Proportion of subjects who have a negative cough stress test at each visit
Measured: 6 weeks, 6 months, 1 year, 2 year, 3 year
Proportion of subjects who meet the criteria of cure at each other visit
Cure is defined as negative Cough Stress Test (CST) and an answer "no" to question 3 "Do you usually experience urine leakage related to coughing, sneezing, or laughing?" of the UDI-6 questionnaire
Measured: 6 weeks, 6 months, 2 year, 3 year
Subject continence status measured by the 24-hour pad weight
The continence status will be described : Proportion of subjects who meet the criteria of dryness defined as a pad weight of less than 8 grams for the current practice Proportion of subjects who meet the criteria of improvement defined as at least a 50% reduction in pad weight from baseline
Measured: 6 weeks, 1 year
Assessment of self reported symptoms and subject QoL through the scoring of validated questionnaires: ICIQ-UI SF, I-QOL, UDI-6 and IIQ-7
The scores of ICIQ-UI short form, I-QOL, UDI-6 and IIQ-7 will be describe at each visit as continuous variables. The evolution of scores from baseline will be presented
Measured: 6 weeks, 6 months, 1 year, 2 year, 3 year
Postoperatively subject impression of improvement (via PGI-I questionnaire) and satisfaction at each post-operative visit
Measured: 6 weeks, 6 months, 1 year, 2 year, 3 year
Assessment of Qmax variations
Qmax (maximum flow rate in uroflowmetry section) raw value (at baseline, 6 weeks and 12 months) and absolute and relative variations from baseline et 6 weeks and 12 months will be described
Measured: 6 weeks, 1year
Assessment of PVR variations
PVR (Post void residual urine volume) raw value (at baseline, 6 weeks and 12 months) and absolute and relative variations from baseline et 6 weeks and 12 months will be described
Measured: 6 weeks, 1 year
Assessment of the operation duration and the type of anaesthesia used
Measured: Operative period
Assessment of device and procedure related adverse events
All device or procedure related Adverse Events (AE) will be summarized and reported as the number and percentage of subjects having this AE and as the number and percentage of AE in Safety population.
Measured: Operative period, 6 weeks, 6 months, 1 year, 2 year, 3 year
Assessment of postoperative pain
Visual Analogue Scale from 0 "no pain" to 10 "extreme pain"
Measured: operative period, 6 weeks, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2014 (estimated)
- Study start16 Dec 2013
- Primary completion4 Nov 2019
- Study completion21 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress Urinary IncontinenceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, post-market, single arm, mutlicenter
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Nicolas Cornu, Pr, Principal investigator, Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02049840
- Sponsor's protocol ID
- SU016
- Acronym
- EASY
- Status last verified
- Sep 2021
- First submitted
- 28 Jan 2014
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The European Study of Altis Single Incision Sling System for Female Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT02049840
- Acronym / sponsor ID
- EASY / SU016
- Conditions
- Stress Urinary Incontinence
- Keywords
- Female sling, Stress Urinary Incontinence, Urination Disorders, Urologic Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2013 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 30 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, post-market, single arm, multicenter study comparing Baseline data to the 12 month and 36 month data in 136 female patients with Stress Urinary Incontinence
Detailed description
This study is a prospective, European Post-Market, one non-controlled arm, multi-centre clinical trial conducted at up to 10 centers in Europe. It is designed to get more clinical information for users (uro-gynecologists) of the Altis Single Incision Sling System for female stress urinary incontinence treatment in terms of objective and subjective cure rate, quality of life improvement, patient satisfaction and safety, especially in long term follow-up (3 years). Clinical data will be collected at baseline, implantation procedure, post-operative at 6 weeks, 6 months, 1, 2 and 3 years
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, post-market, single arm, mutlicenter
| Arm | Type | Receives |
|---|---|---|
| Altis Single Incision Sling System | Experimental | Device: Altis Single Incision Sling SystemAltis Single Incision Sling System |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The subject is female at least 18 years of age
- The subject uses a method of contraception considered effective by the investigator or is not of child-bearing potential
- The subject is able and willing to complete all procedures and follow-up visits indicated in this protocol.
- The subject has confirmed stress urinary incontinence (SUI) through cough stress test at baseline.
- The subject has failed first line treatments (non-invasive therapies, eg. behavioral modification, Pelvic Floor/Kegel exercises, or biofeedback) with good compliance for the treatment
Key exclusion criteria (16 listed)
- The subject had a prior surgical SUI treatment (including bulking agent).
- The subject is having a concomitant Pelvic Organ Prolapse repair or hysterectomy during Altis procedure.
- The subject has incontinence due to neurogenic causes (e.g. multiple sclerosis, spinal cord/brain injury, cerebrovascular accident, detrusor-external sphincter dyssynergia, Parkinson's disease, or similar conditions).
- The subject has predominant or uncontrolled or primary urge incontinence according to investigator judgment
- The patient has detrusor overactivity determined through urodynamics
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 Sling SystemAltis Single Incision Sling (SIS) System is a permanently implantable synthetic sling for the surgical treatment of Stress Urinary Incontinence | Device | Altis Single Incision Sling System |
Primary outcome
Proportion of subjects who meet the criteria of cure at 12 months
Time frame: 1 year
Cure is defined as negative Cough Stress Test (CST) and an answer "no" to question 3 "Do you usually experience urine leakage related to coughing, sneezing, or laughing?" of the UDI-6 questionnaire
10 secondary outcomes
Proportion of subjects who have a negative cough stress test at each visit
Time frame: 6 weeks, 6 months, 1 year, 2 year, 3 year
Proportion of subjects who meet the criteria of cure at each other visit
Time frame: 6 weeks, 6 months, 2 year, 3 year
Subject continence status measured by the 24-hour pad weight
Time frame: 6 weeks, 1 year
Assessment of self reported symptoms and subject QoL through the scoring of validated questionnaires: ICIQ-UI SF, I-QOL, UDI-6 and IIQ-7
Time frame: 6 weeks, 6 months, 1 year, 2 year, 3 year
Postoperatively subject impression of improvement (via PGI-I questionnaire) and satisfaction at each post-operative visit
Time frame: 6 weeks, 6 months, 1 year, 2 year, 3 year
Assessment of Qmax variations
Time frame: 6 weeks, 1year
Assessment of PVR variations
Time frame: 6 weeks, 1 year
Assessment of the operation duration and the type of anaesthesia used
Time frame: Operative period
Assessment of device and procedure related adverse events
Time frame: Operative period, 6 weeks, 6 months, 1 year, 2 year, 3 year
Assessment of postoperative pain
Time frame: operative period, 6 weeks, 6 months, 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
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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.
Jean-Nicolas Cornu, Pr principal investigator
Centre Hospitalier Universitaire de Rouen - Hôpital Charles Nicolle
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Altis Single Incision Sling System in people with Stress Urinary Incontinence, run by Coloplast A/S at 13 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 5 inclusion and 16 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: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Spain, Germany, Italy, Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of subjects who meet the criteria of cure at 12 months (time frame: 1 year). 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 28 Sep 2021.