Trial Outcomes & Findings for A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence (NCT NCT00998790)
NCT ID: NCT00998790
Last Updated: 2018-10-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
114 participants
Primary outcome timeframe
24 months
Results posted on
2018-10-22
Participant Flow
114 subjects were enrolled for this study and 113 treated across 7 sites in Europe.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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114
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Overall Study
Participants Who Were Treated
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113
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Overall Study
COMPLETED
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93
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Overall Study
NOT COMPLETED
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21
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Withdrawal by Subject
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21
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Baseline Characteristics
A Post-Market Study of the AMS AdVance™ Male Sling System for the Treatment of Male Stress Urinary Incontinence
Baseline characteristics by cohort
| Measure |
AMS AdVance Sling Group
n=114 Participants
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.
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|---|---|
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Age, Customized
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66.4 years
STANDARD_DEVIATION 6.7 • n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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114 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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114 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
Belgium
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31 participants
n=5 Participants
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Region of Enrollment
France
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63 participants
n=5 Participants
|
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Region of Enrollment
Germany
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14 participants
n=5 Participants
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Region of Enrollment
Spain
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6 participants
n=5 Participants
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Duration of Incontinence Symptoms
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41.8 years
STANDARD_DEVIATION 28.7 • n=5 Participants
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PRIMARY outcome
Timeframe: 24 monthsPopulation: Baseline to 24 month measurement of 1-hour pad weight test. 113 subject available at baseline, 83 available at 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.
Outcome measures
| Measure |
AMS AdVance Sling Group
n=113 Participants
Male subjects \>40 years old who were implanted with the AMS AdVance Male Sling to treat Stress Urinary Incontinence.
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|---|---|
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Change in 1-hour Pad Weight Test From Baseline to 24 Month Follow-up
Baseline
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48.7 grams
Standard Deviation 73.4
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Change in 1-hour Pad Weight Test From Baseline to 24 Month Follow-up
24 Month Follow-up
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6.6 grams
Standard Deviation 17
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PRIMARY outcome
Timeframe: 24 monthsPopulation: Baseline to 24 month measurement of 24-hour pad weight test. 113 subjects available at baseline, 89 available at 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.
Outcome measures
| Measure |
AMS AdVance Sling Group
n=113 Participants
Male subjects \>40 years old who were implanted with the AMS AdVance Male Sling to treat Stress Urinary Incontinence.
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|---|---|
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Change in 24-hour Pad Weight Test From Baseline to 24 Month Follow-up
Baseline
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113.9 grams
Standard Deviation 79.1
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Change in 24-hour Pad Weight Test From Baseline to 24 Month Follow-up
24 Month Follow-up
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45.0 grams
Standard Deviation 87.6
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PRIMARY outcome
Timeframe: BaselineEvaluate 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
Outcome measures
| Measure |
AMS AdVance Sling Group
n=113 Participants
Male subjects \>40 years old who were implanted with the AMS AdVance Male Sling to treat Stress Urinary Incontinence.
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|---|---|
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Percentage of Subjects in Each Range of Pads Per Day Use
0-1 Pads Per Day
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15.9 percentage of subjects
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Percentage of Subjects in Each Range of Pads Per Day Use
2-3 Pads Per Day
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66.4 percentage of subjects
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Percentage of Subjects in Each Range of Pads Per Day Use
4-5 Pads Per Day
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10.6 percentage of subjects
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Percentage of Subjects in Each Range of Pads Per Day Use
6-7 Pads Per Day
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6.2 percentage of subjects
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Percentage of Subjects in Each Range of Pads Per Day Use
8-9 Pads Per Day
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0.9 percentage of subjects
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Percentage of Subjects in Each Range of Pads Per Day Use
>10 Pads Per Day
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0 percentage of subjects
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PRIMARY outcome
Timeframe: 24 monthsPopulation: 93 subjects who completed the final 24 month follow-up visit
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
Outcome measures
| Measure |
AMS AdVance Sling Group
n=93 Participants
Male subjects \>40 years old who were implanted with the AMS AdVance Male Sling to treat Stress Urinary Incontinence.
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|---|---|
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Percentage of Subjects in Each Range of Pads Per Day Use
0-1 Pads Per Day
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80.6 percentage of subjects
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Percentage of Subjects in Each Range of Pads Per Day Use
2-3 Pads Per Day
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12.9 percentage of subjects
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Percentage of Subjects in Each Range of Pads Per Day Use
4-5 Pads Per Day
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6.5 percentage of subjects
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Percentage of Subjects in Each Range of Pads Per Day Use
6-7 Pads Per Day
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0 percentage of subjects
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Percentage of Subjects in Each Range of Pads Per Day Use
8-9 Pads Per Day
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0 percentage of subjects
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Percentage of Subjects in Each Range of Pads Per Day Use
>10 Pads Per Day
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0 percentage of subjects
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SECONDARY outcome
Timeframe: 24 monthsPopulation: 113 subjects available at baseline. 90 subjects available at 24 month follow-up.
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.
Outcome measures
| Measure |
AMS AdVance Sling Group
n=113 Participants
Male subjects \>40 years old who were implanted with the AMS AdVance Male Sling to treat Stress Urinary Incontinence.
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|---|---|
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To Evaluate Patient Quality of Life
IQOL at Baseline
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55.9 Score on a scale
Standard Deviation 21.6
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To Evaluate Patient Quality of Life
IQOL at 24 Month Follow-up
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85.6 Score on a scale
Standard Deviation 17.3
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To Evaluate Patient Quality of Life
ICIQ-SF at Baseline
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15.5 Score on a scale
Standard Deviation 3.3
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To Evaluate Patient Quality of Life
ICIQ-SF at 24 Month Follow-up
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7.3 Score on a scale
Standard Deviation 5.0
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Adverse Events
AMS AdVance Sling Group
Serious events: 26 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AMS AdVance Sling Group
n=113 participants at risk
Male subjects \>40 years old who were implanted with the AMS AdVance Male Sling to treat Stress Urinary Incontinence.
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|---|---|
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Renal and urinary disorders
Urinary Incontinence- Persistent
|
6.2%
7/113 • Number of events 7 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
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Renal and urinary disorders
Urinary Incontinence- De Novo Stres
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1.8%
2/113 • Number of events 2 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
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Renal and urinary disorders
De Novo Detrusor Instability
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0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
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Renal and urinary disorders
Infection- Incision Site
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0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
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Renal and urinary disorders
Urinary Retention
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0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
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Renal and urinary disorders
Worsening Incontinence
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2.7%
3/113 • Number of events 3 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
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Renal and urinary disorders
Hematoma
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0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
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Renal and urinary disorders
Urethral Perforation
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0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
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Renal and urinary disorders
Difficulty with Erections
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0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
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Renal and urinary disorders
Hematuria
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0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
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Musculoskeletal and connective tissue disorders
Other: Hernia
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1.8%
2/113 • Number of events 3 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
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Cardiac disorders
Other: Syncope/Palpitations/Heart Block
|
1.8%
2/113 • Number of events 2 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
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Cardiac disorders
Other: Cardiac Decompensation
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0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
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|
Musculoskeletal and connective tissue disorders
Other: Carpal Tunnel
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Cardiac disorders
Other: Chest Pain
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
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|
Infections and infestations
Other: Infection, Hernia Mesh
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
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|
Infections and infestations
Other: Infection, Renal
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Infections and infestations
Other: Infection, Septicemia
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Gastrointestinal disorders
Other: Intestinal Hemorrhage
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Vascular disorders
Other: Ischemia, Femoral
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Respiratory, thoracic and mediastinal disorders
Other: Pneumonia
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Respiratory, thoracic and mediastinal disorders
Other: Respiratory Infection
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
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Vascular disorders
Other: Sub-Occlusive Syndrome, Femoral
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Vascular disorders
Other: Varices
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
Other adverse events
| Measure |
AMS AdVance Sling Group
n=113 participants at risk
Male subjects \>40 years old who were implanted with the AMS AdVance Male Sling to treat Stress Urinary Incontinence.
|
|---|---|
|
Renal and urinary disorders
Pain/Disconfort
|
16.8%
19/113 • Number of events 23 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Dysuria
|
7.1%
8/113 • Number of events 8 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Urinary Incontinence- De Novo Stress
|
4.4%
5/113 • Number of events 5 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Urinary Incontinence- De Novo Urge
|
3.5%
4/113 • Number of events 4 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Urinary Track Infection (UTI)
|
6.2%
7/113 • Number of events 8 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Ecchymosis
|
2.7%
3/113 • Number of events 3 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Urinary Urgency
|
2.7%
3/113 • Number of events 3 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
De Novo Detrusor Instability
|
1.8%
2/113 • Number of events 2 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Urinary Incontinence- Persistent
|
1.8%
2/113 • Number of events 2 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Urinary Retention
|
1.8%
2/113 • Number of events 2 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Hematuria
|
1.8%
2/113 • Number of events 2 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Post-void Dribbling
|
1.8%
2/113 • Number of events 2 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Difficulty With Erections
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Urinary Frequency
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Other: Worsening Incontinence
|
6.2%
7/113 • Number of events 7 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Other: Constipation
|
2.7%
3/113 • Number of events 3 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Other: Catheter could not be replaced
|
1.8%
2/113 • Number of events 2 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Skin and subcutaneous tissue disorders
Other: Rash
|
1.8%
2/113 • Number of events 2 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Hepatobiliary disorders
Other: Blood Clots
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Hepatobiliary disorders
Other: Coagulation at the praeputium and glans
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Other: Post Void Blood Loss
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Other Pruritis and Swelling of Genitalia
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Skin and subcutaneous tissue disorders
Other Scrotal Hematoma
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Skin and subcutaneous tissue disorders
Other: Scrotal Numbness
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Skin and subcutaneous tissue disorders
Other: Scrotal Sensitivity
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Other: Urethral Pains
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Blood and lymphatic system disorders
Other: Vein Perforation
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Respiratory, thoracic and mediastinal disorders
Other: Influenza
|
2.7%
3/113 • Number of events 3 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Other: Prostate Cancer
|
1.8%
2/113 • Number of events 2 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Cardiac disorders
Other: Syncope/Palpitations/Heart Block
|
1.8%
2/113 • Number of events 2 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Musculoskeletal and connective tissue disorders
Other: Abdominal Pain
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Other: Bacterial Infection on Penis
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Other: Balanitis
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Eye disorders
Other: Cataract
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Gastrointestinal disorders
Other: Diarrhea
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Endocrine disorders
Other: Dry Mouth
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
General disorders
Other: Fatigue
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Infections and infestations
Other: Foreskin Infection
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Infections and infestations
Other: Fungal Infection
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
General disorders
Other: General Pain
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Other: Hemorrhagic Cystitis
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Blood and lymphatic system disorders
Other: Hemorrhoids
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Cardiac disorders
Other: High Blood Pressure
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Other: Inflammation of Penis
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Other: Itching in Pubis Area
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Endocrine disorders
Other: Lymph Node Swelling
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Other: Nocturia
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Endocrine disorders
Other: Parotiditis
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Vascular disorders
Other: Peripheral Edema
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Respiratory, thoracic and mediastinal disorders
Other: Respiratory Infection
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Musculoskeletal and connective tissue disorders
Other: Rheumatoid Arthritis
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Other: Stress Incontinence
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Other: Stricture
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Endocrine disorders
Other: Thyroid Lump
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Gastrointestinal disorders
Other: Ulcer
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Renal and urinary disorders
Other: Urge Incontinence
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
|
Skin and subcutaneous tissue disorders
Other: Wound Inflammation
|
0.88%
1/113 • Number of events 1 • All adverse events were collected during the study conductance between January 2007 through December 2012.
Adverse events were collected on patients implanted with the device. One participant withdrew from the study prior to the study procedure due to not meeting inclusion/exclusion criteria. One hundred and twenty-three (123) adverse events in 63 subjects were reported as non-serious events. Of the 123 reported events, 70 were device related. Twenty-six (26) subjects experienced 36 serious adverse events; 17 of these events were device related.
|
Additional Information
Laura Olson, Clinical Project Manager
American Medical Systems
Phone: 952-930-6428
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place