Summary

Eligibility
for males ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Benjamin Breyer, MD
Photo of Benjamin Breyer
Benjamin Breyer

Description

Summary

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

Keywords

Stress Urinary Incontinence Urinary Incontinence Urinary Incontinence, Stress AMS 800 Artificial Urinary Sphincter AMS 800 Artificial Urinary Sphincter Recipients

Eligibility

You can join if…

Open to males ages 18 years and up

  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

You CAN'T join if...

  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)

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94110 United States
  • Urology San Antonio Research, PA. accepting new patients
    San Antonio Texas 78229 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boston Scientific Corporation
ID
NCT04088331
Study Type
Observational
Last Updated