Trial Outcomes & Findings for Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling (NCT NCT00937833)
NCT ID: NCT00937833
Last Updated: 2014-12-29
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
1 Month
Results posted on
2014-12-29
Participant Flow
Participant milestones
| Measure |
Urethrovesical Sling
Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
|
Control
No sling placed at the time of prostatectomy
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
77
|
|
Overall Study
COMPLETED
|
58
|
60
|
|
Overall Study
NOT COMPLETED
|
15
|
17
|
Reasons for withdrawal
| Measure |
Urethrovesical Sling
Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
|
Control
No sling placed at the time of prostatectomy
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Procedure delayed; enrollment closed
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
10
|
8
|
|
Overall Study
Withdrawal by Subject
|
4
|
6
|
Baseline Characteristics
Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling
Baseline characteristics by cohort
| Measure |
Urethrovesical Sling
n=73 Participants
Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
|
Control
n=74 Participants
No sling placed at the time of prostatectomy
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 6.1 • n=93 Participants
|
60.6 years
STANDARD_DEVIATION 7.1 • n=4 Participants
|
60.8 years
STANDARD_DEVIATION 6.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=93 Participants
|
74 Participants
n=4 Participants
|
147 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 MonthOutcome measures
| Measure |
Urethrovesical Sling
n=67 Participants
Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
|
Control
n=68 Participants
No sling placed at the time of prostatectomy
|
|---|---|---|
|
Number of Continent Patients Post Prostatectomy
|
37 participants
|
32 participants
|
Adverse Events
Urethrovesical Sling
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Urethrovesical Sling
n=73 participants at risk
Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
|
Control
n=74 participants at risk
No sling placed at the time of prostatectomy
|
|---|---|---|
|
Renal and urinary disorders
Hospitalization
|
2.7%
2/73 • Number of events 2
|
0.00%
0/74
|
|
Infections and infestations
Hospitalization
|
1.4%
1/73 • Number of events 1
|
0.00%
0/74
|
|
Renal and urinary disorders
Intervention to prevent impairment
|
1.4%
1/73 • Number of events 1
|
0.00%
0/74
|
Other adverse events
Adverse event data not reported
Additional Information
Jason Hodde, Clinical Affairs Manager
Cook Biotech Incorporated
Phone: 765-497-3355
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60