Stress Urinary Incontinence
Conditions
Brief summary
To evaluate the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.
Detailed description
Study is designed to evaluate the performance of the AMS 800 Artificial Urinary Sphincter (AUS) in men with primary stress urinary incontinence as measured by pad weight tests.
Interventions
DEVICEAMS 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.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Reduction in 24 Hour Pad Weight Test at 12 Months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at Device Activation | Device Activation | Number of subjects achieving ≥ 50% reduction in urinary incontinence as measured by 24-hour pad weight test at device activation compared to baseline |
| Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at Device Activation | Device Activation | ≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at device activation compared to baseline |
| Change in Number of Pads Per Day at 3 Months | 3 months | Change in number of pads per day at 3 months compared to baseline. Change was calculated by subtracting the number of pads per day at baseline from the number of pads per day at 3 months. |
| Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at 6 Months | 6 months | Number of subjects achieving ≥ 50% reduction in urinary incontinence as measured by 24-hour pad weight test at 6 months post device activation compared to baseline |
| Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related | 3 months, 6 months, and 12 months | Percentage of Participants that Required Revision (Revision Rates), had Serious Adverse Events, and had Serious Adverse Events that are Device and/or Procedure Related at 3 months, 6 months, and 12 months. Adverse event and revision rates are summarized by the Kaplan-Meier estimate with revision/event timing relative to the index procedure. |
| Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 12 Months | 12 months | ≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at 12 months post device activation compared to baseline |
| Change in Number of Pads Per Day at 6 Months | 6 months | Change in number of pads per day at 6 months post-device activation compared to baseline. Change was calculated by subtracting the number of pads per day at baseline from the number of pads per day at 6 months. |
| Change in Number of Pads Per Day at 12 Months | 12 months | Change in number of pads per day at 12 months post-device activation compared to baseline. Change was calculated by subtracting the number of pads per day at baseline from the number of pads per day at 12 months. |
| Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 6 Months | 6 months | ≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at 6 months post device activation compared to baseline |
Countries
Australia, United States
Participant flow
Pre-assignment details
Subjects will be considered enrolled in the study once they sign the informed consent. All enrolled subjects will have been consented prior to the procedure. All enrolled subjects with a surgery initiated (i.e. first incision) will be considered part of the Intent-to-Treat (ITT) population. A total of 145 subjects were enrolled and 115 continued on to undergo the index procedure, qualifying them for inclusion in the ITT population.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 115 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Withdrawal by Subject | 7 |
Baseline characteristics
| Characteristic | AMS 800 Artificial Urinary Sphincter Recipients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 98 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 109 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 100 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 115 |
| other Total, other adverse events | 27 / 115 |
| serious Total, serious adverse events | 17 / 115 |
Outcome results
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
Time frame: 12 months
Population: The analysis was performed on subjects in the Intent to Treat (ITT) population who had available 24-hr pad weight data available at their 12 month follow-up visit. The ITT subject population included all subjects who provided written informed consent to be enrolled into the study, and have a surgery initiated (defined as the first incision).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AMS 800 Artificial Urinary Sphincter Recipients | Number of Subjects With Reduction in 24 Hour Pad Weight Test at 12 Months | 91 Participants |
Comparison: Hypotheses:~H0: p ≤ 0.65 H1: p \> 0.65 where p = the proportion of subjects who are a treatment success.~Hypotheses evaluated using a one-sided exact binomial test.~Power calculation assumed a treatment success rate of 80%. With a one-sided type I error of 0.025 and a type II error of 0.10 (90% power), a sample size of 96 subjects needed to demonstrate the proportion of subjects who are a treatment success exceeds 65%.p-value: <0.001Exact binomial test
Secondary
Change in Number of Pads Per Day at 12 Months
Change in number of pads per day at 12 months post-device activation compared to baseline. Change was calculated by subtracting the number of pads per day at baseline from the number of pads per day at 12 months.
Time frame: 12 months
Population: 101 subjects had data at both baseline and 12 months post device activation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AMS 800 Artificial Urinary Sphincter Recipients | Change in Number of Pads Per Day at 12 Months | -3.9 Pads per day |
Secondary
Change in Number of Pads Per Day at 3 Months
Change in number of pads per day at 3 months compared to baseline. Change was calculated by subtracting the number of pads per day at baseline from the number of pads per day at 3 months.
Time frame: 3 months
Population: 109 subjects had data at both baseline and 3 months post device activation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AMS 800 Artificial Urinary Sphincter Recipients | Change in Number of Pads Per Day at 3 Months | -4.0 Pads per day |
Secondary
Change in Number of Pads Per Day at 6 Months
Change in number of pads per day at 6 months post-device activation compared to baseline. Change was calculated by subtracting the number of pads per day at baseline from the number of pads per day at 6 months.
Time frame: 6 months
Population: 99 subjects had data at both baseline and 6 months post device activation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| AMS 800 Artificial Urinary Sphincter Recipients | Change in Number of Pads Per Day at 6 Months | -4.0 Pads per day |
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 6 months post device activation compared to baseline
Time frame: 6 months
Population: 99 subjects had data at both baseline and 6 months post device activation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AMS 800 Artificial Urinary Sphincter Recipients | Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at 6 Months | 88 Participants |
Secondary
Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at Device Activation
Number of subjects achieving ≥ 50% reduction in urinary incontinence as measured by 24-hour pad weight test at device activation compared to baseline
Time frame: Device Activation
Population: 107 subjects had data at both baseline and device activation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AMS 800 Artificial Urinary Sphincter Recipients | Number of Subjects Achieving ≥ 50% Reduction in 24 Hour Pad Weight Test at Device Activation | 75 Participants |
Secondary
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 12 Months
≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at 12 months post device activation compared to baseline
Time frame: 12 months
Population: 97 subjects had data at both baseline and 6 months post device activation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AMS 800 Artificial Urinary Sphincter Recipients | Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 12 Months | 83 Participants |
Secondary
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 6 Months
≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at 6 months post device activation compared to baseline
Time frame: 6 months
Population: 99 subjects had data at both baseline and 6 months post device activation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AMS 800 Artificial Urinary Sphincter Recipients | Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at 6 Months | 84 Participants |
Secondary
Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at Device Activation
≥ 75% reduction in urinary incontinence as measured by 24-hour pad weight test at device activation compared to baseline
Time frame: Device Activation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AMS 800 Artificial Urinary Sphincter Recipients | Number of Subjects Achieving ≥ 75% Reduction in 24 Hour Pad Weight Test at Device Activation | 70 Participants |
Secondary
Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related
Percentage of Participants that Required Revision (Revision Rates), had Serious Adverse Events, and had Serious Adverse Events that are Device and/or Procedure Related at 3 months, 6 months, and 12 months. Adverse event and revision rates are summarized by the Kaplan-Meier estimate with revision/event timing relative to the index procedure.
Time frame: 3 months, 6 months, and 12 months
Population: The analysis was performed for the Intent to Treat (ITT) population. The ITT subject population included all subjects who provided written informed consent to be enrolled into the study, and have a surgery initiated (defined as the first incision).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS 800 Artificial Urinary Sphincter Recipients | Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related | Incidence of Safety Parameters at 12 months: Serious adverse events | 15.2 Percentage of participants |
| AMS 800 Artificial Urinary Sphincter Recipients | Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related | Incidence of Safety Parameters at 12 months: SAEs that are device and/or procedure related | 8.9 Percentage of participants |
| AMS 800 Artificial Urinary Sphincter Recipients | Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related | Incidence of Safety Parameters at 3 months: Revision Rates | 3.5 Percentage of participants |
| AMS 800 Artificial Urinary Sphincter Recipients | Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related | Incidence of Safety Parameters at 3 months: Serious adverse events | 9.6 Percentage of participants |
| AMS 800 Artificial Urinary Sphincter Recipients | Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related | Incidence of Safety Parameters at 3 months: SAEs that are device and/or procedure related | 5.2 Percentage of participants |
| AMS 800 Artificial Urinary Sphincter Recipients | Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related | ncidence of Safety Parameters at 6 months: Revision Rates | 6.2 Percentage of participants |
| AMS 800 Artificial Urinary Sphincter Recipients | Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related | Incidence of Safety Parameters at 6 months: Serious adverse events | 12.4 Percentage of participants |
| AMS 800 Artificial Urinary Sphincter Recipients | Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related | Incidence of Safety Parameters at 6 months: SAEs that are device and/or procedure related | 7.0 Percentage of participants |
| AMS 800 Artificial Urinary Sphincter Recipients | Percentage of Participants That Required Revision (Revision Rates), Had Serious Adverse Events, and Had Serious Adverse Events That Are Device and/or Procedure Related | Incidence of Safety Parameters at 12 months: Revision Rates | 7.2 Percentage of participants |