Artificial Urinary Sphincter Clinical Outcomes

Completed

• Conditions: Stress Urinary Incontinence

• Registration Number: NCT04088331
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-12
• Study Start: 2019-10-14
• Primary Completion: 2024-05-13
• Study Completion: 2024-05-13
• Results First Submitted: 2025-05-05
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-16
• Last Update Submitted: 2025-07-16
• Results First Posted: 2025-08-03
• Last Update Posted: 2025-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 145

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Reduction in 24 Hour Pad Weight Test at 12 Months	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

Name	Time	Method
Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related	3 months, 6 months, and 12 months	Percentage of Participants that Required Revision (Revision Rates), had Serious Adverse Events, and had Serious Adverse Events that are Device and/or Procedure Related at 3 months, 6 months, and 12 months. Adverse event and revision rates are summarized by the Kaplan-Meier estimate with revision/event timing relative to the index procedure.
Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at Device Activation	Device Activation	Number of subjects achieving ≥ 50% reduction in urinary incontinence as measured by 24-hour pad weight test at device activation compared to baseline
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at Device Activation	Device Activation	≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at device activation compared to baseline
Change in Number of Pads Per Day at 6 Months	6 months	Change in number of pads per day at 6 months post-device activation compared to baseline. Change was calculated by subtracting the number of pads per day at baseline from the number of pads per day at 6 months.
Change in Number of Pads Per Day at 3 Months	3 months	Change in number of pads per day at 3 months compared to baseline. Change was calculated by subtracting the number of pads per day at baseline from the number of pads per day at 3 months.
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 6 Months	6 months	≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at 6 months post device activation compared to baseline
Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at 6 Months	6 months	Number of subjects achieving ≥ 50% reduction in urinary incontinence as measured by 24-hour pad weight test at 6 months post device activation compared to baseline
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 12 Months	12 months	≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at 12 months post device activation compared to baseline
Change in Number of Pads Per Day at 12 Months	12 months	Change in number of pads per day at 12 months post-device activation compared to baseline. Change was calculated by subtracting the number of pads per day at baseline from the number of pads per day at 12 months.

Trial Locations

Locations (18)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

University of Kansas Hospital; 🇺🇸 Kansas City, Kansas, United States

Willis-Knighton Bossier Medical Center; 🇺🇸 Bossier City, Louisiana, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Lahey Clinic Hospital; 🇺🇸 Burlington, Massachusetts, United States

University of Minnesota Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Wake Forest University School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States

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