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Artificial Urinary Sphincter Clinical Outcomes (AUSCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04088331
Recruitment Status : Recruiting
First Posted : September 12, 2019
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Brief Summary:
To evaluate the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.

Condition or disease Intervention/treatment
Stress Urinary Incontinence Device: AMS 800 Artificial Urinary Sphincter

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Study Type : Observational
Estimated Enrollment : 175 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Artificial Urinary Sphincter Clinical Outcomes
Actual Study Start Date : September 27, 2019
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
AMS 800 Artificial Urinary Sphincter Recipients
Adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.
Device: AMS 800 Artificial Urinary Sphincter
The AMS 800 Artificial Urinary Sphincter (AUS) is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence due to reduced urethral/bladder outlet resistance (intrinsic sphincter deficiency). It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra under the control of the patient.




Primary Outcome Measures :
  1. Number of subjects with reduction in 24 hour pad weight test at 12 months [ Time Frame: 12 months ]
    Number of subjects achieving 50% reduction or greater in baseline urinary incontinence as measured by 24-hour pad weight test at 12 months post device activation


Secondary Outcome Measures :
  1. Incidence of safety parameters [ Time Frame: 3 months, 6 months and 12 months ]
    Incidence of safety parameters at 3 months, 6 months, and 12 months. Safety parameters include all adverse events specifically, device and/or procedure related adverse events, revision rates, and serious adverse events

  2. Number of subjects achieving ≥ 50% reduction in 24 hour pad weight test at 6 months [ Time Frame: Device Activation and 6 months ]
    Number of subjects achieving ≥ 50% reduction in urinary incontinence as measured by 24-hour pad weight test at device activation and 6 months post device activation compared to baseline

  3. Number of subjects achieving ≥ 75% reduction in 24 hour pad weight test at 6 and 12 months [ Time Frame: Device Activation, 6 months, and 12 months ]
    ≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at device activation, 6 months, and 12 months post device activation compared to baseline

  4. Number of pads per day [ Time Frame: 3 months, 6 months, and 12 months ]
    Reduction in # of pads per day at 3 months, 6 months and 12 months post-device activation compared to baseline



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will enroll adult males with moderate to severe primary stress urinary incontinence (as assessed by a baseline pad weight test) due to ISD who meet the indications for surgical correction of urinary incontinence.
Criteria

Inclusion Criteria:

  1. Male
  2. ≥ 18 years of age
  3. Has undergone either a radical prostatectomy, transurethral resection of the prostate or other invasive prostate surgery
  4. Demonstrates primary stress urinary incontinence
  5. Positive screening 24-hour pad weight test (≥100 grams)
  6. Experiences at least 3 incontinence episodes per day during baseline diary
  7. Negative urine culture
  8. Willing and able to undergo surgical implantation of the AUS device
  9. Willing and able to comply with the follow-up requirements
  10. Willing and able to forego any other surgical urinary incontinence treatments while participating in the study
  11. Willing and able to sign the informed consent

Exclusion Criteria:

  1. Previously had or currently has a device implanted (AUS/Sling, or otherwise) for treatment of SUI or urge incontinence
  2. Primary urgency incontinence
  3. History of adjuvant or neo-adjuvant radiation therapy, cryotherapy, or high-intensity focused ultrasound therapy
  4. Postvoid residual volume greater that 150 ml or a history of difficulty emptying the bladder
  5. Recurrent vesicourethral anastomotic stricture or urethral stricture disease within the past 6 months
  6. Known urogenital malignancy other than previously treated prostate cancer
  7. Recurrent prostate cancer that is expected to require intervention during the study follow-up period
  8. History of recurrent bladder stones within the past 12 months prior to signing the informed consent
  9. Neurogenic bladder
  10. Need for intermittent catheterization
  11. Known history of bleeding diathesis or coagulopathy
  12. Immunosuppressed or on medical therapy which would impact the immune system
  13. Uncontrolled diabetes, defined as (HbA1c>10)
  14. Has a genitourinary mechanical prosthesis
  15. Undergone bulking procedure within 6 months of the baseline assessment
  16. Poor candidate for surgical procedures and/or anesthesia due to physical or mental conditions
  17. Urinary incontinence due to or complicated by an irreversibly obstructed lower urinary tract
  18. Irresolvable detrusor hyperreflexia or bladder instability
  19. Currently enrolled or plans to enroll in another device or drug clinical trial
  20. Currently using an indwelling catheter or condom catheter for treatment of incontinence and is not willing to discontinue use at least 4 weeks prior to baseline assessment
  21. Known allergy or sensitivity to rifampin or to minocycline HCl or other tetracyclines (only applicable when implanting with InhibiZone version of this device)
  22. Systemic lupus erythematosus because minocycline HCl has been reported to aggravate this condition (only applicable when implanting with InhibiZone version of this device)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088331


Contacts
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Contact: Amanda J Vail, MPH 612-749-5366 amanda.vail@bsci.com

Locations
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United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Bradley Erickson, MD       brad-erickson@uiowa.edu   
Principal Investigator: Bradley Erickson, MD         
United States, Louisiana
Willis-Knighton Physician Network / Ark-La-Tex Urology Recruiting
Bossier City, Louisiana, United States, 71111
Contact: Gerard Henry, MD    318-841-4004    gdhenry@hotmail.com   
Principal Investigator: Gerard Henry, MD         
United States, Massachusetts
Lahey Clinic Hospital Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Alex Vanni, MD       alex.j.vanni@lahey.org   
Principal Investigator: Alex Vanni, MD         
United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Sean Elliott, MD       selliott@umn.edu   
Principal Investigator: Sean Elliott, MD         
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Andrew Peterson, MD       drew.peterson@duke.edu   
Principal Investigator: Andrew Peterson, MD         
Wake Forest University School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Ryan Terlecki, MD       rterlecki@wakehealth.edu   
Principal Investigator: Ryan Terlecki, MD         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Hadley Wood, MD       WOODH@ccf.org   
Principal Investigator: Hadley Wood, MD         
United States, Texas
The Methodist Hospital Research Institute Recruiting
Houston, Texas, United States, 77030
Contact: Timothy Boone, MD       tboone3@houstonmethodist.org   
Principal Investigator: Timothy Boone, MD         
Urology San Antonio Research, PA. Recruiting
San Antonio, Texas, United States, 78229
Contact: Leroy Jones, MD    210-617-4116    leroy.jones2@urologysa.com   
Principal Investigator: Leroy Jones, MD         
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Melissa Kaufman, MD Vanderbilt Urology
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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT04088331    
Other Study ID Numbers: U0669
First Posted: September 12, 2019    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Incontinence, Stress
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations