Prostate Cancer, Urinary Incontinence
Conditions
Keywords
prostate cancer, prostatectomy, incontinence
Brief summary
The purpose of this study is to determine the impact of an absorbable urethrovesical sling on the post-operative return of urinary continence after robot-assisted radical prostatectomy.
Interventions
PROCEDUREProstatectomy
DEVICESurgisis Male Sling
Sponsors
Cook Group Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must have organ confined prostate cancer. * Patients must have PSA\< 15. * Patients must have clinical stage prostate cancer \< cT3. * Patients must be scheduled for robot assisted transperitoneal laparoscopic radical prostatectomy. * Patients must be able to provide written informed consent and HIPAA authorization for release of personal health information. * Patients must be at least 18 years of age.
Exclusion criteria
* Patients must not have previously undergone transurethral resection, laser therapy, microwave therapy, radiofrequency ablation, or other surgery of the prostate. * Patients must not have previously undergone incision of urethral stricture or incision of bladder neck contracture. * Patients must not have previously been diagnosed with urethral stricture, bladder neck contracture or urinary incontinence. * Patients must not have previously been diagnosed with atonic bladder or neurogenic bladder. * Patients must not have significant pre-operative voiding symptoms as defined by an American Urologic Association symptom score of greater than 19. * Patients must not have a prior history of radiation to the pelvis. * Patients must not have persistent bacteriuria that cannot be cleared, as demonstrated by a negative urinalysis or urine culture, within 1 month of surgery. * Patients must not have allergies to pig tissue or pig products or have religious or cultural objection to the use of pig tissue.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Continent Patients Post Prostatectomy | 1 Month |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Urethrovesical Sling Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy. | 73 |
| Control No sling placed at the time of prostatectomy | 74 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 8 |
| Overall Study | Procedure delayed; enrollment closed | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 2 |
| Overall Study | Withdrawal by Subject | 4 | 6 |
Baseline characteristics
| Characteristic | Urethrovesical Sling | Control | Total |
|---|---|---|---|
| Age, Continuous | 60.9 years STANDARD_DEVIATION 6.1 | 60.6 years STANDARD_DEVIATION 7.1 | 60.8 years STANDARD_DEVIATION 6.6 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 73 Participants | 74 Participants | 147 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 73 | 0 / 74 |
| serious Total, serious adverse events | 2 / 73 | 0 / 74 |
Outcome results
Primary
Number of Continent Patients Post Prostatectomy
Time frame: 1 Month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Urethrovesical Sling | Number of Continent Patients Post Prostatectomy | 37 participants |
| Control | Number of Continent Patients Post Prostatectomy | 32 participants |