Artificial Urinary Sphincter Clinical Outcomes (AUSCO)

Boston Scientific

Status: Completed

Conditions: Stress Urinary Incontinence

Treatments: Device: AMS 800 Artificial Urinary Sphincter

Study type: Observational

Funder types: Industry

Identifiers

NCT04088331

U0669

Details and patient eligibility

About

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

Enrollment: 145 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

145 participants in 1 patient group

AMS 800 Artificial Urinary Sphincter Recipients

Description:

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.

Treatment:

Device: AMS 800 Artificial Urinary Sphincter