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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04088331




Registration number
NCT04088331
Ethics application status
Date submitted
10/09/2019
Date registered
12/09/2019

Titles & IDs
Public title
Artificial Urinary Sphincter Clinical Outcomes
Scientific title
Artificial Urinary Sphincter Clinical Outcomes
Secondary ID [1] 0 0
U0669
Universal Trial Number (UTN)
Trial acronym
AUSCO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress Urinary Incontinence 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - AMS 800 Artificial Urinary Sphincter

AMS 800 Artificial Urinary Sphincter Recipients - 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: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with reduction in 24 hour pad weight test at 12 months
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Incidence of safety parameters
Timepoint [1] 0 0
3 months, 6 months and 12 months
Secondary outcome [2] 0 0
Number of subjects achieving = 50% reduction in 24 hour pad weight test at 6 months
Timepoint [2] 0 0
Device Activation and 6 months
Secondary outcome [3] 0 0
Number of subjects achieving = 75% reduction in 24 hour pad weight test at 6 and 12 months
Timepoint [3] 0 0
Device Activation, 6 months, and 12 months
Secondary outcome [4] 0 0
Number of pads per day
Timepoint [4] 0 0
3 months, 6 months, and 12 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/10/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/05/2024
Sample size
Target
Accrual to date
Final
144
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Australian Urology Associates - Melbourne
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
3144 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Utah

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boston Scientific Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Melissa Kaufman, MD
Address 0 0
Vanderbilt Urology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04088331