Randomized Controlled Trial Examining the Return of Urinary Continence After Robot-assisted Radical Prostatectomy With or Without a Urethrovesical Sling
Treatment Plan
Arm/Group Label
Arm/Group Type
Arm/Group Description
Control
No Intervention
Not Provided
Urethrovesical Sling
Experimental
Not Provided
Intervention(s)
Surgisis Male Sling,
Patient eligibility
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 > 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 a prostate size >100 cc as measured on digital rectal
examination or transrectal ultrasound.
- 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 by a negative
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.
For detailed patient eligibility criteria for this clinical trial, please click here to show/hide
