Urinary IncontinenceSU-ACTNCT02490917
ACT™ Balloons Versus Artificial Urinary Sphincter (AMS800™) for the Treatment of Female Stress Urinary Incontinence
A study testing ACT™ device and AMS 800 ™ device in people with Urinary Incontinence, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main objective is to compare the efficacy of AMS800 ™ and ACT ™ devices for the Treatment of Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency on "social continence" at 6 months. Continence is defined by the average number of pads used per day. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urinary Incontinence
- What is being tested?
- ACT™ device and AMS 800 ™ device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to Dec 2019
- 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
- Patients suffering from stress urinary incontinence due to ISD.
- Patients with maximum urethral closure pressure(PCUM) < 50 cm H2O or bladder leakage pressure < 100 cm H2O
- Patient who accepted surgery
- Patient with normal urethra-cystoscopy (no foreign body nor calculus)
- Patient with effort leaks on clinical examination
- Patient who never had SUA or ACT ™ balloon
- Affiliation to health insurance
- Written informed consent
Who cannot join
- Patient pregnant or breastfeeding
- Patient with a life expectancy of less than 2 years
- Patient with overactive bladder uncontrolled and considered an against-indication for surgery
- Patient with reduced bladder compliance
- Patient with significant post-void residual volume according to the judgment of the Investigator
- Patient with a history of pelvic radiotherapy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Urology Department, Pitié-Salpêtrière University Hospital
Paris, 75013
CHARTIER-KASTLER EMMANUEL, MD, PhD, +33(0)142177129, emmanuel.chartier-kastler@aphp.fr
About this study
Official title: Randomised Comparative Prospective Study of the Treatment of Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency : ACT™ Balloon Versus Artificial Urinary Sphincter ( AMS800™)
The main objective is to compare the efficacy of AMS800 ™ and ACT ™ devices for the Treatment of Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency on "social continence" at 6 months.
Continence is defined by the average number of pads used per day. The social continence is defined by (0-1) pad per day
Read the detailed description
Prospective multicenter randomized controlled trial comparing two parallel arms: the implantation of an adjustable balloon (experimental arm) versus implantation of an artificial urinary sphincter AMS800 ™ (control arm), for the treatment of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD).
This research will focus on the assessment of improved continence, quality of life, and Cost-Effectiveness Analysis.
The tested device ACT ™ device is a prosthesis used to support the bladder neck and proximal urethra increasing the urethral coaptation and supporting to the bladder neck to prevent urine leakage at stress.
The medical device AMS 800 ™(control arm) is an implantable device made of silicone elastomer filled with saline/X-Ray fluid, used in the treatment of stress urinary incontinence related to ISD. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by closing the urethra and allowing the patient to void according to the patient's will and opening of the device (sub-cutaneous pump).
An inclusion visit will take place between 3 months and 1 month before the date of the surgery to explain the purpose of the study, the benefits and risks for patients, and describe the comparative medical devices.
Patients will be randomized before surgery (at D0).
The follow-up will be conducted up to one year, with scheduled visits at M1, M3, M6 and M12.
Secondary endpoints will be assessed during scheduled visits.
The medico-economic assessment will be made during the same follow-up period. This period will take into account improvement of urinary continence and results reported from the 3rd month as well as the morbidity and mortality related to the implementation of the medical device up to 1 year.
.
- Conditions
- Urinary Incontinence
- Being tested
- ACT™ device, AMS 800 ™ device
- Keywords
- Female urinary incontinence, Sphincter deficiency
- Medical subject headings
- Urinary Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT™ deviceDevice
Implantation of the Adjustable Continence Therapy device ACT®
AMS 800 ™ deviceDevice
Implantation of the artificial urinary sphincter AMS 800 ™
| Study group | Role | What they receive |
|---|---|---|
| ACT™ device | Experimental | Patients randomized to receive the Adjustable Continence Therapy device ACT™ Receives: Device: ACT™ device |
| AMS 800 ™ device | Other | Patients randomized to receive the artificial urinary sphincter AMS 800 ™ Receives: Device: AMS 800 ™ device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social continence defined by the use of 0-1 adult protective pads per day
Measured: 6 months
Secondary outcomes (4)
Assessment of incontinence (number and type of protective pads used per day)
Measured: 12 months
impact on quality of life assessed by EQ-5D Health Questionnaire.
Measured: 12 months
assessment of the urinary flow using ICIQ-FLUTS questionnaire
Measured: 12 months
Assessment of Urinary Profile Symptoms using UPS questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHARTIER-KASTLER EMMANUEL, MD, PhD, Principal investigator, Urology Department, Pitié-Salpêtrière University Hospital, 75013 Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490917
- Sponsor's protocol ID
- P130941
- Acronym
- SU-ACT
- Status last verified
- Nov 2017
- First submitted
- 2 Jul 2015
- Last updated
- 20 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Comparative Prospective Study of the Treatment of Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency : ACT™ Balloon Versus Artificial Urinary Sphincter ( AMS800™)
- ClinicalTrials.gov ID
- NCT02490917
- Acronym / sponsor ID
- SU-ACT / P130941
- Conditions
- Urinary Incontinence
- Keywords
- Female urinary incontinence, Sphincter deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Jul 2015 (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.
The main objective is to compare the efficacy of AMS800 ™ and ACT ™ devices for the Treatment of Female Stress Urinary Incontinence due to Intrinsic Sphincter Deficiency on "social continence" at 6 months.
Continence is defined by the average number of pads used per day. The social continence is defined by (0-1) pad per day
Detailed description
Prospective multicenter randomized controlled trial comparing two parallel arms: the implantation of an adjustable balloon (experimental arm) versus implantation of an artificial urinary sphincter AMS800 ™ (control arm), for the treatment of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD).
This research will focus on the assessment of improved continence, quality of life, and Cost-Effectiveness Analysis.
The tested device ACT ™ device is a prosthesis used to support the bladder neck and proximal urethra increasing the urethral coaptation and supporting to the bladder neck to prevent urine leakage at stress.
The medical device AMS 800 ™(control arm) is an implantable device made of silicone elastomer filled with saline/X-Ray fluid, used in the treatment of stress urinary incontinence related to ISD. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by closing the urethra and allowing the patient to void according to the patient's will and opening of the device (sub-cutaneous pump).
An inclusion visit will take place between 3 months and 1 month before the date of the surgery to explain the purpose of the study, the benefits and risks for patients, and describe the comparative medical devices.
Patients will be randomized before surgery (at D0).
The follow-up will be conducted up to one year, with scheduled visits at M1, M3, M6 and M12.
Secondary endpoints will be assessed during scheduled visits.
The medico-economic assessment will be made during the same follow-up period. This period will take into account improvement of urinary continence and results reported from the 3rd month as well as the morbidity and mortality related to the implementation of the medical device up to 1 year.
.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT™ device | Experimental | Device: ACT™ devicePatients randomized to receive the Adjustable Continence Therapy device ACT™ |
| AMS 800 ™ device | Other | Device: AMS 800 ™ devicePatients randomized to receive the artificial urinary sphincter AMS 800 ™ |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients suffering from stress urinary incontinence due to ISD.
- Patients with maximum urethral closure pressure(PCUM) < 50 cm H2O or bladder leakage pressure < 100 cm H2O
- Patient who accepted surgery
- Patient with normal urethra-cystoscopy (no foreign body nor calculus)
- Patient with effort leaks on clinical examination
Key exclusion criteria (6 listed)
- Patient pregnant or breastfeeding
- Patient with a life expectancy of less than 2 years
- Patient with overactive bladder uncontrolled and considered an against-indication for surgery
- Patient with reduced bladder compliance
- Patient with significant post-void residual volume according to the judgment of the Investigator
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 |
|---|---|---|
| ACT™ deviceImplantation of the Adjustable Continence Therapy device ACT® | Device | ACT™ device |
| AMS 800 ™ deviceImplantation of the artificial urinary sphincter AMS 800 ™ | Device | AMS 800 ™ device |
Primary outcome
Social continence defined by the use of 0-1 adult protective pads per day
Time frame: 6 months
4 secondary outcomes
Assessment of incontinence (number and type of protective pads used per day)
Time frame: 12 months
impact on quality of life assessed by EQ-5D Health Questionnaire.
Time frame: 12 months
assessment of the urinary flow using ICIQ-FLUTS questionnaire
Time frame: 12 months
Assessment of Urinary Profile Symptoms using UPS questionnaire
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
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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.
CHARTIER-KASTLER EMMANUEL, MD, PhD principal investigator
Urology Department, Pitié-Salpêtrière University Hospital, 75013 Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT™ device and AMS 800 ™ device in people with Urinary Incontinence, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CHARTIER-KASTLER EMMANUEL, MD, PhD (+33(0)142177129, emmanuel.chartier-kastler@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social continence defined by the use of 0-1 adult protective pads per day (time frame: 6 months). 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 20 Nov 2017.