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Comparison of Urodynamic Evaluation in Post-Radiation Salvage Prostatectomy Versus Prostatectomy-only Patients

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Prostate Cancer

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Trial Information

Comparison of Urodynamic Evaluation in Post-Radiation Salvage Prostatectomy Versus Prostatectomy-only Patients

Study Participation:

You will come to the urology clinic for 1 visit. At this visit, a video urodynamics test
will be performed. The urodynamics test is used to check bladder and urinary function using
pressure and volume measurements with x-ray images.

Pressure-monitoring catheters will be inserted into your bladder and rectum, and your
bladder function will be checked as the bladder is slowly filled with fluid. Measurements
will then be made of your bladder capacity (the volume of urine the bladder can hold),
bladder and abdominal (stomach) pressures, and bladder compliance (the bladder's ability to
hold urine) throughout the course of this study. This procedure will take about 90 minutes
to complete.

After the urodynamics test is completed, you will complete a questionnaire about your
urinary function and your quality-of-life (regarding daily living after surgical treatment
for prostate cancer). The questionnaire will take about 30 minutes to complete.

If you have had urodynamic testing with Dr. Westney within the past year, we would like your
consent to use the data from that test, and also for completion of the questionnaire
mentioned in the previous paragraph. You will complete this informed consent and
questionnaire being sent with a return envelope and will not need to come to the urology
clinic for a visit.

Length of Study:

Once you have completed the urodynamics testing and questionnaire, your participation on
this study is complete.

This is an investigational study. The video urodynamics test is approved by the FDA and
commercially available. Up to 50 patients will take part in this study. All will be
enrolled at M. D. Anderson.

Inclusion Criteria:

1. Men who have undergone radical prostatectomy, via an open or minimally invasive
approach, as primary treatment for a diagnosis of prostate cancer.

2. Men who have undergone salvage prostatectomy for recurrence after first-line
radiation therapy for prostate cancer.

3. Men who underwent prostatectomy at least one year prior to study entry date. Men who
received perioperative (or peri-XRT) chemotherapy or hormone therapy are eligible.

Exclusion Criteria:

1. Men who underwent other primary or secondary treatments for prostate cancer--hormone
therapy as only treatment, cryosurgery, adjuvant radiation after prostatectomy

2. Men with a history of neurogenic bladder, as demonstrated by previous urodynamics.

3. Men with a history of severe outlet obstruction due to longstanding benign prostatic
hyperplasia. This will be demonstrated objectively by documentation in the patient's
history of preoperative AUA symptom score greater than 15 or a history of urinary
retention or nocturia greater than 2 episodes per night.

4. Men who underwent additional reconstructive procedures at the time of or subsequent
to prostatectomy, including augmentation, urethral sling, or urinary diversion.

Type of Study:


Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Comparison of Urodynamic Changes Related to Radiation Post Salvage Prostatectomy versus Prostatectomy Only

Outcome Description:

Comparison of urodynamic changes related to radiation by performing urodynamics (measurement of bladder pressure, electrical activity, and radiographic imaging) in patients post salvage prostatectomy versus prostatectomy only, using a 2-sample t-test to test for differences between the 2 groups of men with respect to urodynamic score.

Outcome Time Frame:

Compilation of patient urodynamics test completed in single 90 minute office visit

Safety Issue:


Principal Investigator

Ouida L. Westney, MD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

June 2007

Completion Date:

May 2010

Related Keywords:

  • Prostate Cancer
  • Prostate
  • Urodynamic Evaluation
  • Prostatectomy
  • Salvage prostatectomy
  • Bladder compliance
  • Radiation Therapy
  • External beam radiation therapy
  • Quality-of-life
  • Prostatic Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030