Artificial Urinary Sphincter Clinical Outcomes

Stress Urinary Incontinence Clinical Trial

— AUSCO  

Official title:

Artificial Urinary Sphincter Clinical Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04088331
• Other study ID #: U0669
• Status: Completed
• Start date: October 14, 2019
• Est. completion date: May 13, 2024

Study information

• Verified date: May 2024
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: May 13, 2024
• Est. primary completion date: May 13, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Stress Urinary Incontinence
• Urinary Incontinence
• Urinary Incontinence, Stress

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.

Locations

Country	Name	City	State
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	Australian Urology Associates	Melbourne	Victoria
United States	University of Colorado Hospital	Aurora	Colorado
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	Willis-Knighton Bossier Medical Center	Bossier City	Louisiana
United States	Lahey Clinic Hospital	Burlington	Massachusetts
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	MD Anderson Cancer Center	Houston	Texas
United States	The Methodist Hospital Research Institute	Houston	Texas
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of Kansas Hospital	Kansas City	Kansas
United States	University of Minnesota Medical Center	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	University of Utah	Salt Lake City	Utah
United States	Urology San Antonio Research, PA.	San Antonio	Texas
United States	University of California, San Francisco	San Francisco	California
United States	Wake Forest University School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with reduction in 24 hour pad weight test at 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	12 months
Secondary	Incidence of safety parameters	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	3 months, 6 months and 12 months
Secondary	Number of subjects achieving = 50% reduction in 24 hour pad weight test at 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	Device Activation and 6 months
Secondary	Number of subjects achieving = 75% reduction in 24 hour pad weight test at 6 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	Device Activation, 6 months, and 12 months
Secondary	Number of pads per day	Reduction in # of pads per day at 3 months, 6 months and 12 months post-device activation compared to baseline	3 months, 6 months, and 12 months