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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04088331
Recruitment Status : Active, not recruiting
First Posted : September 12, 2019
Last Update Posted : January 20, 2023
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date September 10, 2019
First Posted Date September 12, 2019
Last Update Posted Date January 20, 2023
Actual Study Start Date October 14, 2019
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 11, 2019)		 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 5, 2021)
  • 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 device and/or procedure related adverse events, revision rates, and serious adverse events
  • 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
  • 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
  • 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
Original Secondary Outcome Measures
 (submitted: September 11, 2019)
  • 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
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Artificial Urinary Sphincter Clinical Outcomes
Official Title Artificial Urinary Sphincter Clinical Outcomes
Brief Summary To evaluate the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Stress Urinary Incontinence
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Device: AMS 800 Artificial Urinary Sphincter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: January 18, 2023)		 144
Original Estimated Enrollment
 (submitted: September 11, 2019)		 175
Estimated Study Completion Date June 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility 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 or presents with continuous incontinence
  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. Postvoid residual volume greater that 150 ml or a history of difficulty emptying the bladder
  4. Recurrent vesicourethral anastomotic stricture or urethral stricture disease within the past 6 months
  5. Known urogenital malignancy other than previously treated prostate cancer
  6. Recurrent prostate cancer that is expected to require intervention during the study follow-up period
  7. History of recurrent bladder stones within the past 12 months prior to signing the informed consent
  8. Neurogenic bladder
  9. Need for intermittent catheterization
  10. Known history of bleeding diathesis or coagulopathy
  11. Immunosuppressed or on medical therapy which would impact the immune system
  12. Uncontrolled diabetes, defined as (HbA1c>10)
  13. Has a genitourinary mechanical prosthesis that was implanted within 3 months from the date of consent
  14. Had a post-implantation infection associated with the device after genitourinary mechanical prosthesis was implanted
  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)
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04088331
Other Study ID Numbers U0669
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Boston Scientific Corporation
Original Responsible Party Same as current
Current Study Sponsor Boston Scientific Corporation
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Melissa Kaufman, MD Vanderbilt Urology
PRS Account Boston Scientific Corporation
Verification Date January 2023