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Randomized Controlled Trial Examining the Return of Urinary Continence After Robot-assisted Radical Prostatectomy With or Without a Urethrovesical Sling


N/A
18 Years
N/A
Open (Enrolling)
Male
Urinary Incontinence, Prostate Cancer

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Trial Information

Randomized Controlled Trial Examining the Return of Urinary Continence After Robot-assisted Radical Prostatectomy With or Without a Urethrovesical Sling


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Outcome Measure:

Incontinence score post prostatectomy

Outcome Time Frame:

12 Months

Safety Issue:

No

Principal Investigator

Chandru Sundaram, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana Cancer Pavilion

Authority:

United States: Institutional Review Board

Study ID:

08-015

NCT ID:

NCT00937833

Start Date:

November 2009

Completion Date:

December 2014

Related Keywords:

  • Urinary Incontinence
  • Prostate Cancer
  • prostate cancer
  • prostatectomy
  • incontinence
  • Prostatic Neoplasms
  • Urinary Incontinence

Name

Location

Indiana University School of Medicine Indianapolis, Indiana  46204
Clarian North Medical Center Carmel, Indiana  46032
Urology of San Antonio Research San Antonio, Texas  78229