Stress Urinary IncontinenceBALLANCENCT01500603
Periurethral Pro-ACTTM Balloons vs Retrourethral AdvanceXP(TM) Male Sling for Post-prostatectomy Incontinence
A study testing AdvanceXP Male sling device and Pro-ACT balloon device in people with Stress Urinary Incontinence, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Background: Periurethral Pro-ACT balloons and retrourethral AdvanceXP(TM) male sling have been presented as efficient treatments for management of stress urinary incontinence (SUI) following radical prostatectomy (RP), but no comparative study of these two techniques has been published. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- AdvanceXP Male sling device and Pro-ACT balloon device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Jun 2014
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Patient presenting mild to moderate stress urinary incontinence (20g < 72 hours pad-test < 300g) following radical prostatectomy more than 1 year ago.
- Patient capable of roaming, independent and capable of using toilet without any trouble.
- Patients able to answer to questionnaire and communicate in French
- Informed consent
- Patients with social security
Who cannot join
- Uncontrolled prostatic adenocarcinoma or PSA > 1 ng/ml
- Maximum urinary flow rate < 15 ml/sec
- Postvoid residual volume > 150 ml
- Urinated volume in 24h > 3000 ml
- Uninhibited detrusor contractions associated with leakage during the preoperative urodynamic assessment (realized under anticholinergic if the patient is usually under this medication)
- Severe incontinence (Pad test > 300g/24h)
Show all 17Show fewer
- History of artificial urinary sphincter
- Known neurologic bladder dysfunction
- History of neurological disease which can interfere with the urinary symptoms
- Presence of a urethral stenosis or of an anastomotic stricture during the preoperative endoscopy.
- Previous treatment with pelvic radiation therapy in 6 months before inclusion
- Uncontrolled urinary tract infection
- Patients affected by an infiltrative bladder tumour
- Patients with bladder stones
- Severe constitutional hemorrhagic disease or haemophilia
- Deep depression of immune system
- Severe renal impairment or obstructive pathology of the upper urinary tract with severe renal impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Randomized, Multicentric, Comparative Trial of Two Devices in Surgical Treatment of Post-radical Prostatectomy Stress Urinary Incontinence: Periurethral Pro-ACTTM Balloons and AdvanceXP(TM) Retrourethral Male Sling
Background: Periurethral Pro-ACT balloons and retrourethral AdvanceXP(TM) male sling have been presented as efficient treatments for management of stress urinary incontinence (SUI) following radical prostatectomy (RP), but no comparative study of these two techniques has been published. The investigators aims were to compare the efficacy of the two devices and provide data about their cost effectiveness.
Hypothesis: The study is based on the superiority hypothesis that AdvanceXP male slings is more efficacious than Pro-ACT balloons at one year follow-up.
Read more
Primary objective: The primary objective of this study is to compare the efficacy of the AdvanceXP retrourethral male sling and periurethral Pro-ACT balloons management of SUI after RP at one year follow-up.
Secondary objectives:
- Comprehensive comparative medical evaluation of the two devices in terms of efficacy
- Complete evaluation of the side effects of the two techniques
- Evaluation of the quality of life
- Evaluation of patient satisfaction
- Cost-effectiveness study of the device (total cost over one year of each of the two techniques, differential cost-effectiveness ratio (cost adjusted by QALY), differential cost-effectiveness ratio in terms adjusted to success rate, recommendations that can be made for assessing the potential coverage by the French healthcare system) Population: Patients with history of RP without cancer recurrence, presenting pure SUI on urodynamics (without detrusor overactivity), of mild to moderate degree (24hour pad-test < 300g).
Study design: This is a prospective, randomized, multicentric (9 tertiary reference centers), comparative trial of the two devices (with a superiority hypothesis). The total number of subjects required is 240 and inclusion period is 12 months. Follow-up consists in 4 visits at 1, 3, 6 and 12 months, with data collection (pad use, uroflowmetry, quality of life validated questionnaires ICIQ-SF and EQ-5D, 24-hr pad test, patient satisfaction with PGI-I and report of any secondary effect). Statistical evaluation is carried out at the end of the follow-up, in intent to treat.
Medical evaluation:
Main criterion:failure of the treatment, defined by reduction of less than 50% of incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical device for SUI.
Secondary outcome criteria
- pad usage per day
- quantitative reduction of the 24hr-pad test
- complications (infection, erosion, hematoma, acute urinary retention)
- number of re-interventions or re-admissions during follow-up
- quality of life measured by the ICIQ-SF questionnaire
- patient satisfaction by the PGI-I questionnaire
Economic evaluation:
- Study of the total cost over one year in each case
- Adjustment of cost of each device to quality of life (QALY evaluation)
- Cost effectiveness study
- Proposals will be made to state at which level the two devices should be covered by the healthcare system.
Read the detailed description
Background: Stress urinary incontinence (SUI) is a common adverse event of radical prostatectomy (RP) for localized prostate cancer and can dramatically impact quality of life. Management of SUI after RP is based on conservative measures and pelvic floor muscle training. In case of failure of this first line therapy, surgical treatment is required. In recent years, periurethral Pro-ACT balloons and retrourethral AdvanceXP male sling have been proven to be efficient to manage SUI after RP in case of mild to moderate symptoms. Pro-ACT balloons are placed under general anesthesia via a perineal approach, laterally to the membranous urethra under the bladder neck. This device results in an external compression of the urethra. Further adjustment of the compression is possible under local anesthesia since the balloons are linked to a subcutaneous titanium port. AdvanceXP male sling is placed under general anesthesia via a perineal approach, by transobturator route, and results in a suspension of the membranous urethra relocating the bladder neck. If multiple reports have claimed for the efficacy of these two devices, they have never been compared in a prospective comparative trial. Our aims were to compare the efficacy of the two devices and provide data about their cost effectiveness.
Hypothesis: The study is based on the superiority hypothesis that Advance male slings is more efficacious than Pro-ACT balloons at one year follow-up.
Objectives:
The primary objective of this study is to compare the efficacy of the Advance retrourethral male sling and periurethral Pro-ACT balloons for post-prostatectomy stress urinary incontinence (SUI) management.
The secondary objectives of this work are:
- Comprehensive medical evaluation of these two emerging devices in terms of efficiency using the usual criteria in the field of urinary incontinence
- Complete evaluation of the side effects of the two techniques
- Evaluation of the quality of life
- Cost-effectiveness study of the device (Total cost over one year of each of the two techniques, differential cost-effectiveness ratio (cost adjusted by QALY), differential cost-effectiveness ratio in terms adjusted to success rate, recommendations that can be made for assessing the potential coverage by the French healthcare system
Population: The study concerns patients presenting SUI following radical prostatectomy for prostate cancer. Patients must be older than 18, without cancer recurrence, and must present pure SUI on urodynamics (without detrusor overactivity), and mild to moderate incontinence (24hour pad-test < 300g). Every patient showing urethral stricture at preoperative cystoscopy is excluded from the study.
Study design: This is a prospective, randomized, multicentric (9 tertiary reference centers), comparative trial of the two devices (with a superiority hypothesis). The study begins with a 12 months inclusion period. The total number of subjects required is 240. At the end of the inclusion process, a randomization in two arms is carried out. Follow-up consists in 4 visits at 1, 3, 6 and 12 months, with data collection (pad use, uroflowmetry, quality of life validated questionnaires ICIQ-SF and EQ-5D, 24-hr pad test, patient satisfaction with PGI-I and report of any secondary effect). Statistical evaluation is carried out at the end of the follow-up, in intent to treat.
Medical evaluation:
The main criterion of the study is failure of the treatment, defined by reduction of less than 50% of incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical device for SUI management in the year after operation.
Secondary criteria are focused on efficacy and tolerance and evaluated during follow-up at 1, 3, 6 and 12 months on the following criteria:
- pad usage per day
- quantitative reduction of the 24hr-pad test
- complications (infection, erosion, hematoma, acute urinary retention)
- number of re-interventions or re-admissions during follow-up
- quality of life measured by the ICIQ-SF questionnaire
- patient satisfaction by the PGI-I questionnaire The statistical evaluation on the main criterion will be carried out by the chi-square test. Variables with a known predictive value on efficiency (radiation therapy, severity of incontinence) will be studied by logistic regression then multivariate analysis. The results will be adjusted on the centers (multicentric study). The quantitative variables will be compared by Mann-Whitney test.
Economic evaluation: The economic evaluation will be carried out according to the following manner:
- A study of the total cost over one year of each device, based on the data collected during the clinical trial and including all the events that required medical care (visits, complications, reinterventions, readmissions), but also the cost of pads (not supported by healthcare system, and only supported by the patient).
- From this study led on cost and of the collection of quality of life data, the cost of each device will be adjusted to quality of life (QALY evaluation)
- A cost effectiveness study will also be lead, by adjusting cost to success rate of each technique
- Proposals will be made to state at which level the two devices should be covered by the healthcare system.
- Conditions
- Stress Urinary Incontinence
- Being tested
- AdvanceXP Male sling device, Pro-ACT balloon device
- Keywords
- post-radical prostatectomy, stress urinary incontinence, periurethral Pro-ACT balloons, AdvanceXP retrourethral male 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.
AdvanceXP Male sling deviceDevice
Patients will receive AdvanceXP retrourethral male sling (polypropylene mesh) implantation under general or loco-regional anaesthesia, by perineal approach. The sling is placed via transobturator route.
Pro-ACT balloon deviceDevice
Patients will receive Pro-ACT balloons implantation under general or loco-regional anaesthesia, by perineal approach. The balloons are placed under X-ray control laterally to the urethra, under the bladder neck. The extremity of the device (titanium port), linked to the balloon, is located subcutaneously in the scrotum. During post-operative visits, readjustments of the volume of the balloons will be made under local anaesthesia. The volume will be increased or decreased according to the patients symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients will receive AdvanceXP retrourethral male sling implantation under general or loco-regional anaesthesia, by perineal approach. The sling is placed via transobturator route Receives: Device: AdvanceXP Male sling device |
| Active comparator | Active comparator | Patients will receive Pro-ACT balloons implantation under general or loco-regional anaesthesia, by perineal approach. The balloons are placed under X-ray control laterally to the urethra, under the bladder neck. The extremity of the device (titanium port), linked to the balloon, is located subcutaneously in the scrotum. During post-operative visits, readjustments of the volume of the balloons will be made under local anaesthesia. The volume will be increased or decreased according to the patients symptoms. Receives: Device: Pro-ACT balloon device |
What is being measured
The primary outcome is the main question the study is designed to answer.
failure of the treatment, defined by reduction of less than 50% of incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical device for SUI management in the year after operation
Measured: 12 months after surgical treatment
Secondary outcomes (2)
complications
- pad usage per day
- quantitative reduction of the 24hr-pad test
- complications (infection, erosion, hematoma, acute urinary retention)
- number of re-interventions or re-admissions during follow-up
- quality of life measured by the ICIQ-SF questionnaire
- patient satisfaction by the PGI-I questionnaire
Measured: 1, 3 6 and 12 months after surgical treatment
Cost-effectiveness study of the device
[Total cost over one year of each of the two techniques, differential cost-effectiveness ratio (cost adjusted by QALY), differential cost-effectiveness ratio in terms adjusted to success rate, recommendations that can be made for assessing the potential coverage by the French healthcare system]
Measured: 12 months after surgical treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2011 (estimated)
- Study startMar 2013
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: lack of inclusion in the study
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Haab, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01500603
- Sponsor's protocol ID
- P100143
- Acronym
- BALLANCE
- Status last verified
- Oct 2014
- First submitted
- 23 Dec 2011
- Last updated
- 8 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Multicentric, Comparative Trial of Two Devices in Surgical Treatment of Post-radical Prostatectomy Stress Urinary Incontinence: Periurethral Pro-ACTTM Balloons and AdvanceXP(TM) Retrourethral Male Sling
- ClinicalTrials.gov ID
- NCT01500603
- Acronym / sponsor ID
- BALLANCE / P100143
- Conditions
- Stress Urinary Incontinence
- Keywords
- post-radical prostatectomy, stress urinary incontinence, periurethral Pro-ACT balloons, AdvanceXP retrourethral male sling
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lack of inclusion in the study
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Dec 2011 (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.
Background: Periurethral Pro-ACT balloons and retrourethral AdvanceXP(TM) male sling have been presented as efficient treatments for management of stress urinary incontinence (SUI) following radical prostatectomy (RP), but no comparative study of these two techniques has been published. The investigators aims were to compare the efficacy of the two devices and provide data about their cost effectiveness.
Hypothesis: The study is based on the superiority hypothesis that AdvanceXP male slings is more efficacious than Pro-ACT balloons at one year follow-up.
Primary objective: The primary objective of this study is to compare the efficacy of the AdvanceXP retrourethral male sling and periurethral Pro-ACT balloons management of SUI after RP at one year follow-up.
Secondary objectives:
- Comprehensive comparative medical evaluation of the two devices in terms of efficacy
- Complete evaluation of the side effects of the two techniques
- Evaluation of the quality of life
- Evaluation of patient satisfaction
- Cost-effectiveness study of the device (total cost over one year of each of the two techniques, differential cost-effectiveness ratio (cost adjusted by QALY), differential cost-effectiveness ratio in terms adjusted to success rate, recommendations that can be made for assessing the potential coverage by the French healthcare system) Population: Patients with history of RP without cancer recurrence, presenting pure SUI on urodynamics (without detrusor overactivity), of mild to moderate degree (24hour pad-test < 300g).
Study design: This is a prospective, randomized, multicentric (9 tertiary reference centers), comparative trial of the two devices (with a superiority hypothesis). The total number of subjects required is 240 and inclusion period is 12 months. Follow-up consists in 4 visits at 1, 3, 6 and 12 months, with data collection (pad use, uroflowmetry, quality of life validated questionnaires ICIQ-SF and EQ-5D, 24-hr pad test, patient satisfaction with PGI-I and report of any secondary effect). Statistical evaluation is carried out at the end of the follow-up, in intent to treat.
Medical evaluation:
Main criterion:failure of the treatment, defined by reduction of less than 50% of incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical device for SUI.
Secondary outcome criteria
- pad usage per day
- quantitative reduction of the 24hr-pad test
- complications (infection, erosion, hematoma, acute urinary retention)
- number of re-interventions or re-admissions during follow-up
- quality of life measured by the ICIQ-SF questionnaire
- patient satisfaction by the PGI-I questionnaire
Economic evaluation:
- Study of the total cost over one year in each case
- Adjustment of cost of each device to quality of life (QALY evaluation)
- Cost effectiveness study
- Proposals will be made to state at which level the two devices should be covered by the healthcare system.
Detailed description
Background: Stress urinary incontinence (SUI) is a common adverse event of radical prostatectomy (RP) for localized prostate cancer and can dramatically impact quality of life. Management of SUI after RP is based on conservative measures and pelvic floor muscle training. In case of failure of this first line therapy, surgical treatment is required. In recent years, periurethral Pro-ACT balloons and retrourethral AdvanceXP male sling have been proven to be efficient to manage SUI after RP in case of mild to moderate symptoms. Pro-ACT balloons are placed under general anesthesia via a perineal approach, laterally to the membranous urethra under the bladder neck. This device results in an external compression of the urethra. Further adjustment of the compression is possible under local anesthesia since the balloons are linked to a subcutaneous titanium port. AdvanceXP male sling is placed under general anesthesia via a perineal approach, by transobturator route, and results in a suspension of the membranous urethra relocating the bladder neck. If multiple reports have claimed for the efficacy of these two devices, they have never been compared in a prospective comparative trial. Our aims were to compare the efficacy of the two devices and provide data about their cost effectiveness.
Hypothesis: The study is based on the superiority hypothesis that Advance male slings is more efficacious than Pro-ACT balloons at one year follow-up.
Objectives:
The primary objective of this study is to compare the efficacy of the Advance retrourethral male sling and periurethral Pro-ACT balloons for post-prostatectomy stress urinary incontinence (SUI) management.
The secondary objectives of this work are:
- Comprehensive medical evaluation of these two emerging devices in terms of efficiency using the usual criteria in the field of urinary incontinence
- Complete evaluation of the side effects of the two techniques
- Evaluation of the quality of life
- Cost-effectiveness study of the device (Total cost over one year of each of the two techniques, differential cost-effectiveness ratio (cost adjusted by QALY), differential cost-effectiveness ratio in terms adjusted to success rate, recommendations that can be made for assessing the potential coverage by the French healthcare system
Population: The study concerns patients presenting SUI following radical prostatectomy for prostate cancer. Patients must be older than 18, without cancer recurrence, and must present pure SUI on urodynamics (without detrusor overactivity), and mild to moderate incontinence (24hour pad-test < 300g). Every patient showing urethral stricture at preoperative cystoscopy is excluded from the study.
Study design: This is a prospective, randomized, multicentric (9 tertiary reference centers), comparative trial of the two devices (with a superiority hypothesis). The study begins with a 12 months inclusion period. The total number of subjects required is 240. At the end of the inclusion process, a randomization in two arms is carried out. Follow-up consists in 4 visits at 1, 3, 6 and 12 months, with data collection (pad use, uroflowmetry, quality of life validated questionnaires ICIQ-SF and EQ-5D, 24-hr pad test, patient satisfaction with PGI-I and report of any secondary effect). Statistical evaluation is carried out at the end of the follow-up, in intent to treat.
Medical evaluation:
The main criterion of the study is failure of the treatment, defined by reduction of less than 50% of incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical device for SUI management in the year after operation.
Secondary criteria are focused on efficacy and tolerance and evaluated during follow-up at 1, 3, 6 and 12 months on the following criteria:
- pad usage per day
- quantitative reduction of the 24hr-pad test
- complications (infection, erosion, hematoma, acute urinary retention)
- number of re-interventions or re-admissions during follow-up
- quality of life measured by the ICIQ-SF questionnaire
- patient satisfaction by the PGI-I questionnaire The statistical evaluation on the main criterion will be carried out by the chi-square test. Variables with a known predictive value on efficiency (radiation therapy, severity of incontinence) will be studied by logistic regression then multivariate analysis. The results will be adjusted on the centers (multicentric study). The quantitative variables will be compared by Mann-Whitney test.
Economic evaluation: The economic evaluation will be carried out according to the following manner:
- A study of the total cost over one year of each device, based on the data collected during the clinical trial and including all the events that required medical care (visits, complications, reinterventions, readmissions), but also the cost of pads (not supported by healthcare system, and only supported by the patient).
- From this study led on cost and of the collection of quality of life data, the cost of each device will be adjusted to quality of life (QALY evaluation)
- A cost effectiveness study will also be lead, by adjusting cost to success rate of each technique
- Proposals will be made to state at which level the two devices should be covered by the healthcare system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: AdvanceXP Male sling devicePatients will receive AdvanceXP retrourethral male sling implantation under general or loco-regional anaesthesia, by perineal approach. The sling is placed via transobturator route |
| Active comparator | Active comparator | Device: Pro-ACT balloon devicePatients will receive Pro-ACT balloons implantation under general or loco-regional anaesthesia, by perineal approach. The balloons are placed under X-ray control laterally to the urethra, under the bladder neck. The extremity of the device (titanium port), linked to the balloon, is located subcutaneously in the scrotum. During post-operative visits, readjustments of the volume of the balloons will be made under local anaesthesia. The volume will be increased or decreased according to the patients symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years
- Patient presenting mild to moderate stress urinary incontinence (20g < 72 hours pad-test < 300g) following radical prostatectomy more than 1 year ago.
- Patient capable of roaming, independent and capable of using toilet without any trouble.
- Patients able to answer to questionnaire and communicate in French
- Informed consent
Key exclusion criteria (17 listed)
- Uncontrolled prostatic adenocarcinoma or PSA > 1 ng/ml
- Maximum urinary flow rate < 15 ml/sec
- Postvoid residual volume > 150 ml
- Urinated volume in 24h > 3000 ml
- Uninhibited detrusor contractions associated with leakage during the preoperative urodynamic assessment (realized under anticholinergic if the patient is usually under this medication)
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 |
|---|---|---|
| AdvanceXP Male sling devicePatients will receive AdvanceXP retrourethral male sling (polypropylene mesh) implantation under general or loco-regional anaesthesia, by perineal approach. The sling is placed via transobturator route. | Device | Experimental |
| Pro-ACT balloon devicePatients will receive Pro-ACT balloons implantation under general or loco-regional anaesthesia, by perineal approach. The balloons are placed under X-ray control laterally to the urethra, under the bladder neck. The extremity of the device (titanium port), linked to the balloon, is located subcutaneously in the scrotum. During post-operative visits, readjustments of the volume of the balloons will be made under local anaesthesia. The volume will be increased or decreased according to the patients symptoms. | Device | Active comparator |
Primary outcome
failure of the treatment, defined by reduction of less than 50% of incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical device for SUI management in the year after operation
Time frame: 12 months after surgical treatment
2 secondary outcomes
complications
Time frame: 1, 3 6 and 12 months after surgical treatment
Cost-effectiveness study of the device
Time frame: 12 months after surgical treatment
Results and safety
The study was stopped early (reason given: lack of inclusion in the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2014.
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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.
François Haab principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AdvanceXP Male sling device and Pro-ACT balloon device in people with Stress 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 6 inclusion and 17 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 8 Oct 2014. 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?
The study was stopped early (reason given: lack of inclusion in the study). Results are not available in the source record.
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?
failure of the treatment, defined by reduction of less than 50% of incontinence on 24-hr pad test, explantation of the device or implantation of a new surgical device for SUI management in the year after operation (time frame: 12 months after surgical treatment). 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 8 Oct 2014.