Stress Urinary IncontinenceNCT00998790
A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence
A study testing American Medical Systems (AMS) AdVance™ Male Sling System in people with Stress Urinary Incontinence, run by Boston Scientific Corporation at 3 sites in 2 countries.
Trial summary
A prospective, multi-center study of the AdVance Male Sling for Stress Urinary Incontinence. The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Stress Urinary Incontinence
- What is being tested?
- American Medical Systems (AMS) AdVance™ Male Sling System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2007to Dec 2012
- Phase
- Interventional
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject has agreed to be implanted with the AMS AdVance Male Sling System.
- The subject is willing and able to give valid informed consent.
- The subject is ≥40 years of age.
- The subject has confirmed stress urinary incontinence for at least 6 months and uses no more than 8 pads per day for incontinence management and has less than 250 grams on the 24-hour pad weight test.
- The subject has any of the following: an observable degree of incontinence during stress related activities, more than one pad is used in a 24 hour period, has more than two episodes of incontinence per day.
- Internal sphincter contractility confirmed by endoscopic view.
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- The subject's primary etiology is TUR, TURP, or radical prostatectomy.
- Pre-existing urological conditions, other than incontinence have been treated and are under control.
- The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol.
- The subject is a good surgical candidate.
Who cannot join
- The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
- The subject has a post-void residual ≥ 100 cc.
- The subject has detrusor-external sphincter dyssynergia.
- The subject has a urinary tract infection (UTI).
- The subject was treated with pelvic radiation within the last 6 months.
- The subject currently has an inflatable penile prosthesis.
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- The subject self-catheterizes.
- The subject has symptomatic or unstable bladder neck structure disease.
- The subject has a history of urethral strictures that may require repetitive instrumentation.
- The subject has previously had a urethral Sling System, an AMS Sphincter 800™, or any implanted device for the treatment of urinary incontinence (not including bulking agents).
- The subject has a history of connective tissue or autoimmune conditions.
- The subject has a compromised immune system.
- The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction.
- The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
Hopital Edouard Herriot
Lyon, 69435
Clinique Jules Verne
Nantes, Cedex 3, 44314
About this study
A prospective, multi-center study of the AdVance Male Sling for Stress Urinary Incontinence. The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication. This study is not designed to statistically demonstrate safety and efficacy of the device.
Read the detailed description
A prospective, multi-center study conducted under a common implant and follow-up protocol. The study will collect pre-operative urologic testing, medical history and subject quality of life (Incontinence Quality of Life Questionaire). Intra-operative procedural data will be collected.
Pad weight and incontinence severity rating (using the ICIQ survey) will be used to characterize continence status.
Post-operative complications, urologic testing, and subject quality of life will be collected at six weeks and three, six, 12, and 24 months.
- Conditions
- Stress Urinary Incontinence
- Being tested
- American Medical Systems (AMS) AdVance™ Male Sling System
- Keywords
- Urinary Incontinence, Stress, Intrinsic sphincter deficiency, Secondary, TUR, TURP, Radical prostatectomy, Open prostatectomy, Post-suprapubic prostatectomy
- Medical subject headings
- Urinary Incontinence, Stress, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
American Medical Systems (AMS) AdVance™ Male Sling SystemDevice
Also called Device: AdVance Male Sling
The AMS AdVance™ Male Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD). The AdVance™ Male Sling System procedure is minimally invasive and consists of using two single-use needle passers and passing them through two small incisions over the obturator foramen. The needles are pushed in an arc through the tissue and exited at a perineal incision. Once the passers are through the perineal incision, the Sling System mesh arms are attached to the needles which are then pulled back through the needle track to their points of origin over the obturator foramen. The Sling System is subsequently tensioned and all incisions are closed.
| Study group | Role | What they receive |
|---|---|---|
| AMS AdVance Sling Group | Experimental | European Male subjects >40 years old who were implanted with the AMS AdVance Male Sling to treat Stress Urinary Incontinence. Receives: Device: American Medical Systems (AMS) AdVance™ Male Sling System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 1-hour Pad Weight Test From Baseline to 24 Month Follow-up
1 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months.
Measured: 24 months
Change in 24-hour Pad Weight Test From Baseline to 24 Month Follow-up
24 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months.
Measured: 24 months
Percentage of Subjects in Each Range of Pads Per Day Use
Evaluate the proportion of subjects using the following categories of pads per day from baseline to the final 24 month visit follow up 0 to 1 pads per day; 2 -3 pads per day; 4-5 pads per day; 6-7 pads per day; 8-9 pads per day; 10 or greater pads per day
Measured: Baseline
Percentage of Subjects in Each Range of Pads Per Day Use
Evaluate the proportion of subjects using the following categories of pads per day from baseline to the final 24 month visit follow up 0 to 1 pads per day; 2 -3 pads per day; 4-5 pads per day; 6-7 pads per day; 8-9 pads per day; 10 or greater pads per day
Measured: 24 months
Secondary outcomes (1)
To Evaluate Patient Quality of Life
The Incontinence Quality of Life Questionnaire (I-QOL) is a 22 questionnaire that evaluates a subject's quality of life with respect to urinary problems/incontinence. A lower score correlates with more severe incontinence, and an increase from baseline indicates an improvement in quality of life. The score scale is 0 - 100.
The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is a 4 question tool that quantifies the impact on quality of life from incontinence. A decrease from baseline to follow-up indicates an improvement in quality of life. The score scale is 0-21.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startJan 2007
- Primary completionDec 2012
- Study completionDec 2012
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 Stress Urinary IncontinenceStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Armin Becker, MD, Principal investigator, Oberarzt der Urologischen Klinik GrosshadernDirk de Ridder, Professor, Principal investigator, UZ GasthuisbergPedro Arano, MD, Principal investigator, Fundacion PuigvertFrancois Haab, Professor, Principal investigator, Institution Tenon HospitalOlivier Haillot, Professor, Principal investigator, Hopital BretonneauPhilippe Chauveau, MD, Principal investigator, Clinique Jules VerneHakim Fassi-Fehri, MD, Principal investigator, Hopital Edouard Herriot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998790
- Sponsor's protocol ID
- MC0602
- Status last verified
- Jan 2018
- First submitted
- 8 Oct 2009
- Last updated
- 22 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Publications on study data currently in draft by physicians.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence
- ClinicalTrials.gov ID
- NCT00998790
- Acronym / sponsor ID
- MC0602
- Conditions
- Stress Urinary Incontinence
- Keywords
- Urinary Incontinence, Stress, Intrinsic sphincter deficiency, Secondary, TUR, TURP, Radical prostatectomy, Open prostatectomy, Post-suprapubic prostatectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 20 Oct 2009 (estimated)
- Results
- Posted 22 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, multi-center study of the AdVance Male Sling for Stress Urinary Incontinence. The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication. This study is not designed to statistically demonstrate safety and efficacy of the device.
Detailed description
A prospective, multi-center study conducted under a common implant and follow-up protocol. The study will collect pre-operative urologic testing, medical history and subject quality of life (Incontinence Quality of Life Questionaire). Intra-operative procedural data will be collected.
Pad weight and incontinence severity rating (using the ICIQ survey) will be used to characterize continence status.
Post-operative complications, urologic testing, and subject quality of life will be collected at six weeks and three, six, 12, and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMS AdVance Sling Group | Experimental | Device: American Medical Systems (AMS) AdVance™ Male Sling SystemEuropean Male subjects >40 years old who were implanted with the AMS AdVance Male Sling to treat Stress Urinary Incontinence. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- The subject has agreed to be implanted with the AMS AdVance Male Sling System.
- The subject is willing and able to give valid informed consent.
- The subject is ≥40 years of age.
- The subject has confirmed stress urinary incontinence for at least 6 months and uses no more than 8 pads per day for incontinence management and has less than 250 grams on the 24-hour pad weight test.
- The subject has any of the following: an observable degree of incontinence during stress related activities, more than one pad is used in a 24 hour period, has more than two episodes of incontinence per day.
Key exclusion criteria (14 listed)
- The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods.
- The subject has a post-void residual ≥ 100 cc.
- The subject has detrusor-external sphincter dyssynergia.
- The subject has a urinary tract infection (UTI).
- The subject was treated with pelvic radiation within the last 6 months.
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 |
|---|---|---|
| American Medical Systems (AMS) AdVance™ Male Sling SystemAlso: Device: AdVance Male SlingThe AMS AdVance™ Male Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD). The AdVance™ Male Sling System procedure is minimally invasive and consists of using two single-use needle passers and passing them through two small incisions over the obturator foramen. The needles are pushed in an arc through the tissue and exited at a perineal incision. Once the passers are through the perineal incision, the Sling System mesh arms are attached to the needles which are then pulled back through the needle track to their points of origin over the obturator foramen. The Sling System is subsequently tensioned and all incisions are closed. | Device | AMS AdVance Sling Group |
Primary outcome
Change in 1-hour Pad Weight Test From Baseline to 24 Month Follow-up
Time frame: 24 months
1 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months.
Change in 24-hour Pad Weight Test From Baseline to 24 Month Follow-up
Time frame: 24 months
24 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months.
Percentage of Subjects in Each Range of Pads Per Day Use
Time frame: Baseline
Evaluate the proportion of subjects using the following categories of pads per day from baseline to the final 24 month visit follow up 0 to 1 pads per day; 2 -3 pads per day; 4-5 pads per day; 6-7 pads per day; 8-9 pads per day; 10 or greater pads per day
Percentage of Subjects in Each Range of Pads Per Day Use
Time frame: 24 months
Evaluate the proportion of subjects using the following categories of pads per day from baseline to the final 24 month visit follow up 0 to 1 pads per day; 2 -3 pads per day; 4-5 pads per day; 6-7 pads per day; 8-9 pads per day; 10 or greater pads per day
1 secondary outcome
To Evaluate Patient Quality of Life
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Publications on study data currently in draft by physicians.
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Allogeneic Use of Expanded Mesenchymal Stem Cells Derived From Adipose Tissue (HC106), Female Urinary Incontinence Women Over 50 Years Old
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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.
Armin Becker, MD principal investigator
Oberarzt der Urologischen Klinik Grosshadern
Dirk de Ridder, Professor principal investigator
UZ Gasthuisberg
Pedro Arano, MD principal investigator
Fundacion Puigvert
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing American Medical Systems (AMS) AdVance™ Male Sling System in people with Stress Urinary Incontinence, run by Boston Scientific Corporation at 3 sites in 2 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 10 inclusion and 14 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 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Belgium. 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 22 Oct 2018). 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?
Change in 1-hour Pad Weight Test From Baseline to 24 Month Follow-up (time frame: 24 months). The study lists 4 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 22 Oct 2018; AzTrials last refreshed its copy on 8 Nov 2026.