Stress Urinary Incontinence
Conditions
Keywords
Urinary Incontinence, Stress, Intrinsic sphincter deficiency, Secondary, TUR, TURP, Radical prostatectomy, Open prostatectomy, Post-suprapubic prostatectomy
Brief summary
A prospective, multi-center study of the AdVance Male Sling for Stress Urinary Incontinence. The purpose of this study is to obtain surgical technique data for use in physician education and training and to collect early clinical outcomes data for future publication. This study is not designed to statistically demonstrate safety and efficacy of the device.
Detailed description
A prospective, multi-center study conducted under a common implant and follow-up protocol. The study will collect pre-operative urologic testing, medical history and subject quality of life (Incontinence Quality of Life Questionaire). Intra-operative procedural data will be collected. Pad weight and incontinence severity rating (using the ICIQ survey) will be used to characterize continence status. Post-operative complications, urologic testing, and subject quality of life will be collected at six weeks and three, six, 12, and 24 months.
Interventions
DEVICEAmerican Medical Systems (AMS) AdVance™ Male Sling System
The AMS AdVance™ Male Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD). The AdVance™ Male Sling System procedure is minimally invasive and consists of using two single-use needle passers and passing them through two small incisions over the obturator foramen. The needles are pushed in an arc through the tissue and exited at a perineal incision. Once the passers are through the perineal incision, the Sling System mesh arms are attached to the needles which are then pulled back through the needle track to their points of origin over the obturator foramen. The Sling System is subsequently tensioned and all incisions are closed.
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject has agreed to be implanted with the AMS AdVance Male Sling System. 2. The subject is willing and able to give valid informed consent. 3. The subject is ≥40 years of age. 4. The subject has confirmed stress urinary incontinence for at least 6 months and uses no more than 8 pads per day for incontinence management and has less than 250 grams on the 24-hour pad weight test. 5. The subject has any of the following: an observable degree of incontinence during stress related activities, more than one pad is used in a 24 hour period, has more than two episodes of incontinence per day. 6. Internal sphincter contractility confirmed by endoscopic view. 7. The subject's primary etiology is TUR, TURP, or radical prostatectomy. 8. Pre-existing urological conditions, other than incontinence have been treated and are under control. 9. The subject is willing and able to return for follow-up evaluations and questionnaire completion according to the study protocol. 10. The subject is a good surgical candidate.
Exclusion criteria
1. The subject has a neurogenic bladder condition that is not treatable or controllable by pharmacological or alternative methods. 2. The subject has a post-void residual ≥ 100 cc. 3. The subject has detrusor-external sphincter dyssynergia. 4. The subject has a urinary tract infection (UTI). 5. The subject was treated with pelvic radiation within the last 6 months. 6. The subject currently has an inflatable penile prosthesis. 7. The subject self-catheterizes. 8. The subject has symptomatic or unstable bladder neck structure disease. 9. The subject has a history of urethral strictures that may require repetitive instrumentation. 10. The subject has previously had a urethral Sling System, an AMS Sphincter 800™, or any implanted device for the treatment of urinary incontinence (not including bulking agents). 11. The subject has a history of connective tissue or autoimmune conditions. 12. The subject has a compromised immune system. 13. The subject has renal insufficiency, and upper and/or lower urinary tract relative obstruction. 14. The subject's reading level is judged inadequate for reading and understanding the quality of life questionnaires and other study materials.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 1-hour Pad Weight Test From Baseline to 24 Month Follow-up | 24 months | 1 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months. |
| Change in 24-hour Pad Weight Test From Baseline to 24 Month Follow-up | 24 months | 24 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months. |
| Percentage of Subjects in Each Range of Pads Per Day Use | Baseline | Evaluate the proportion of subjects using the following categories of pads per day from baseline to the final 24 month visit follow up 0 to 1 pads per day; 2 -3 pads per day; 4-5 pads per day; 6-7 pads per day; 8-9 pads per day; 10 or greater pads per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate Patient Quality of Life | 24 months | The Incontinence Quality of Life Questionnaire (I-QOL) is a 22 questionnaire that evaluates a subject's quality of life with respect to urinary problems/incontinence. A lower score correlates with more severe incontinence, and an increase from baseline indicates an improvement in quality of life. The score scale is 0 - 100. The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is a 4 question tool that quantifies the impact on quality of life from incontinence. A decrease from baseline to follow-up indicates an improvement in quality of life. The score scale is 0-21. |
Countries
Belgium, France
Participant flow
Recruitment details
114 subjects were enrolled for this study and 113 treated across 7 sites in Europe.
Participants by arm
| Arm | Count |
|---|---|
| AMS AdVance Sling Group European Male subjects \>40 years old who were implanted with the AMS AdVance Male Sling to treat Stress Urinary Incontinence.
American Medical Systems (AMS) AdVance™ Male Sling System: The AMS AdVance™ Male Sling System was developed to treat urinary stress incontinence in men resulting from intrinsic sphincter deficiency (ISD). The AdVance™ Male Sling System procedure is minimally invasive and consists of using two single-use needle passers and passing them through two small incisions over the obturator foramen. The needles are pushed in an arc through the tissue and exited at a perineal incision. Once the passers are through the perineal incision, the Sling System mesh arms are attached to the needles which are then pulled back through the needle track to their points of origin over the obturator foramen. The Sling System is subsequently tensioned and all incisions are closed. | 114 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 21 |
Baseline characteristics
| Characteristic | AMS AdVance Sling Group |
|---|---|
| Age, Customized | 66.4 years STANDARD_DEVIATION 6.7 |
| Duration of Incontinence Symptoms | 41.8 years STANDARD_DEVIATION 28.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 114 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Belgium | 31 participants |
| Region of Enrollment France | 63 participants |
| Region of Enrollment Germany | 14 participants |
| Region of Enrollment Spain | 6 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 63 / 113 |
| serious Total, serious adverse events | 26 / 113 |
Outcome results
Primary
Change in 1-hour Pad Weight Test From Baseline to 24 Month Follow-up
1 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months.
Time frame: 24 months
Population: Baseline to 24 month measurement of 1-hour pad weight test. 113 subject available at baseline, 83 available at 24 month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMS AdVance Sling Group | Change in 1-hour Pad Weight Test From Baseline to 24 Month Follow-up | Baseline | 48.7 grams | Standard Deviation 73.4 |
| AMS AdVance Sling Group | Change in 1-hour Pad Weight Test From Baseline to 24 Month Follow-up | 24 Month Follow-up | 6.6 grams | Standard Deviation 17 |
Primary
Change in 24-hour Pad Weight Test From Baseline to 24 Month Follow-up
24 hour pad weight tests were conducted at baseline at all successive follow-up visits. Baseline scores were compared to last visit follow-up at 24 months.
Time frame: 24 months
Population: Baseline to 24 month measurement of 24-hour pad weight test. 113 subjects available at baseline, 89 available at 24 month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMS AdVance Sling Group | Change in 24-hour Pad Weight Test From Baseline to 24 Month Follow-up | Baseline | 113.9 grams | Standard Deviation 79.1 |
| AMS AdVance Sling Group | Change in 24-hour Pad Weight Test From Baseline to 24 Month Follow-up | 24 Month Follow-up | 45.0 grams | Standard Deviation 87.6 |
Primary
Percentage of Subjects in Each Range of Pads Per Day Use
Evaluate the proportion of subjects using the following categories of pads per day from baseline to the final 24 month visit follow up 0 to 1 pads per day; 2 -3 pads per day; 4-5 pads per day; 6-7 pads per day; 8-9 pads per day; 10 or greater pads per day
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS AdVance Sling Group | Percentage of Subjects in Each Range of Pads Per Day Use | 0-1 Pads Per Day | 15.9 percentage of subjects |
| AMS AdVance Sling Group | Percentage of Subjects in Each Range of Pads Per Day Use | 2-3 Pads Per Day | 66.4 percentage of subjects |
| AMS AdVance Sling Group | Percentage of Subjects in Each Range of Pads Per Day Use | 4-5 Pads Per Day | 10.6 percentage of subjects |
| AMS AdVance Sling Group | Percentage of Subjects in Each Range of Pads Per Day Use | 6-7 Pads Per Day | 6.2 percentage of subjects |
| AMS AdVance Sling Group | Percentage of Subjects in Each Range of Pads Per Day Use | 8-9 Pads Per Day | 0.9 percentage of subjects |
| AMS AdVance Sling Group | Percentage of Subjects in Each Range of Pads Per Day Use | >10 Pads Per Day | 0 percentage of subjects |
Primary
Percentage of Subjects in Each Range of Pads Per Day Use
Evaluate the proportion of subjects using the following categories of pads per day from baseline to the final 24 month visit follow up 0 to 1 pads per day; 2 -3 pads per day; 4-5 pads per day; 6-7 pads per day; 8-9 pads per day; 10 or greater pads per day
Time frame: 24 months
Population: 93 subjects who completed the final 24 month follow-up visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AMS AdVance Sling Group | Percentage of Subjects in Each Range of Pads Per Day Use | 0-1 Pads Per Day | 80.6 percentage of subjects |
| AMS AdVance Sling Group | Percentage of Subjects in Each Range of Pads Per Day Use | 2-3 Pads Per Day | 12.9 percentage of subjects |
| AMS AdVance Sling Group | Percentage of Subjects in Each Range of Pads Per Day Use | 4-5 Pads Per Day | 6.5 percentage of subjects |
| AMS AdVance Sling Group | Percentage of Subjects in Each Range of Pads Per Day Use | 6-7 Pads Per Day | 0 percentage of subjects |
| AMS AdVance Sling Group | Percentage of Subjects in Each Range of Pads Per Day Use | 8-9 Pads Per Day | 0 percentage of subjects |
| AMS AdVance Sling Group | Percentage of Subjects in Each Range of Pads Per Day Use | >10 Pads Per Day | 0 percentage of subjects |
Secondary
To Evaluate Patient Quality of Life
The Incontinence Quality of Life Questionnaire (I-QOL) is a 22 questionnaire that evaluates a subject's quality of life with respect to urinary problems/incontinence. A lower score correlates with more severe incontinence, and an increase from baseline indicates an improvement in quality of life. The score scale is 0 - 100. The International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) is a 4 question tool that quantifies the impact on quality of life from incontinence. A decrease from baseline to follow-up indicates an improvement in quality of life. The score scale is 0-21.
Time frame: 24 months
Population: 113 subjects available at baseline. 90 subjects available at 24 month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMS AdVance Sling Group | To Evaluate Patient Quality of Life | IQOL at Baseline | 55.9 Score on a scale | Standard Deviation 21.6 |
| AMS AdVance Sling Group | To Evaluate Patient Quality of Life | IQOL at 24 Month Follow-up | 85.6 Score on a scale | Standard Deviation 17.3 |
| AMS AdVance Sling Group | To Evaluate Patient Quality of Life | ICIQ-SF at Baseline | 15.5 Score on a scale | Standard Deviation 3.3 |
| AMS AdVance Sling Group | To Evaluate Patient Quality of Life | ICIQ-SF at 24 Month Follow-up | 7.3 Score on a scale | Standard Deviation 5 |