Status:
COMPLETED
Artificial Urinary Sphincter Clinical Outcomes
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Stress Urinary Incontinence
Eligibility:
MALE
18+ years
Brief Summary
To evaluate the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.
Eligibility Criteria
Inclusion
- Male
- ≥ 18 years of age
- Has undergone either a radical prostatectomy, transurethral resection of the prostate or other invasive prostate surgery
- Demonstrates primary stress urinary incontinence
- Positive screening 24-hour pad weight test (≥100 grams)
- Experiences at least 3 incontinence episodes per day during baseline diary or presents with continuous incontinence
- Negative urine culture
- Willing and able to undergo surgical implantation of the AUS device
- Willing and able to comply with the follow-up requirements
- Willing and able to forego any other surgical urinary incontinence treatments while participating in the study
- Willing and able to sign the informed consent
Exclusion
- Previously had or currently has a device implanted (AUS/Sling, or otherwise) for treatment of SUI or urge incontinence
- Primary urgency incontinence
- Postvoid residual volume greater that 150 ml or a history of difficulty emptying the bladder
- Recurrent vesicourethral anastomotic stricture or urethral stricture disease within the past 6 months
- Known urogenital malignancy other than previously treated prostate cancer
- Recurrent prostate cancer that is expected to require intervention during the study follow-up period
- History of recurrent bladder stones within the past 12 months prior to signing the informed consent
- Neurogenic bladder
- Need for intermittent catheterization
- Known history of bleeding diathesis or coagulopathy
- Immunosuppressed or on medical therapy which would impact the immune system
- Uncontrolled diabetes, defined as (HbA1c\>10)
- Has a genitourinary mechanical prosthesis that was implanted within 3 months from the date of consent
- Had a post-implantation infection associated with the device after genitourinary mechanical prosthesis was implanted
- Undergone bulking procedure within 6 months of the baseline assessment
- Poor candidate for surgical procedures and/or anesthesia due to physical or mental conditions
- Urinary incontinence due to or complicated by an irreversibly obstructed lower urinary tract
- Irresolvable detrusor hyperreflexia or bladder instability
- Currently enrolled or plans to enroll in another device or drug clinical trial
- 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
- Known allergy or sensitivity to rifampin or to minocycline HCl or other tetracyclines (only applicable when implanting with InhibiZone version of this device)
- Systemic lupus erythematosus because minocycline HCl has been reported to aggravate this condition (only applicable when implanting with InhibiZone version of this device)
Key Trial Info
Start Date :
October 14 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 13 2024
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT04088331
Start Date
October 14 2019
End Date
May 13 2024
Last Update
August 3 2025
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, San Francisco
San Francisco, California, United States, 94110
2
University of Colorado Hospital
Aurora, Colorado, United States, 80045
3
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
4
University of Kansas Hospital
Kansas City, Kansas, United States, 66160-7234