Prostate Cancer Clinical Trial

Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Prostate Cancer

Estimated Enrollment:

150

Study ID:

NCT00937833

Recruitment Status:

Completed

Sponsor:

Cook Group Incorporated

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There are 2 Locations for this study

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Indiana University School of Medicine
Indianapolis Indiana, 46202, United States
Urology of San Antonio Research
San Antonio Texas, 78229, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

150

Study ID:

NCT00937833

Recruitment Status:

Completed

Sponsor:


Cook Group Incorporated

How clear is this clinincal trial information?

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