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Urodynamic Evaluation in Post-radiation Salvage Prostatectomy Patients

This study has been terminated.
(Terminated due to slow accrual.)
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00901420
First received: May 12, 2009
Last updated: July 27, 2012
Last verified: July 2012

May 12, 2009
July 27, 2012
June 2007
May 2010   (final data collection date for primary outcome measure)
Comparison of Urodynamic Changes Related to Radiation Post Salvage Prostatectomy versus Prostatectomy Only [ Time Frame: Compilation of patient urodynamics test completed in single 90 minute office visit ] [ Designated as safety issue: No ]
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.
Compare bladder and voiding function of men who have had a prostatectomy alone or who have had a prostatectomy after radiation therapy. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00901420 on ClinicalTrials.gov Archive Site
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Urodynamic Evaluation in Post-radiation Salvage Prostatectomy Patients
Comparison of Urodynamic Evaluation in Post-Radiation Salvage Prostatectomy Versus Prostatectomy-only Patients

Objectives:

The primary objective of this study is to determine whether bladder compliance is significantly lower in men who undergo prostatectomy for recurrence following primary radiation therapy than in men who undergo prostatectomy as primary treatment.

The secondary objective is to examine the quality-of-life items addressed in the UCLA Prostate Cancer Index for differences between the two populations. The investigators will also look at secondary objective urodynamic measures, such as bladder capacity, to assess for a difference.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Men, seen at MD Anderson Cancer Center, who underwent radical prostatectomy as the first-line treatment for their prostate cancer or underwent salvage prostatectomy for recurrence after first-line radiation treatment; or underwent prostatectomy at least one year prior to study entry date or received perioperative (or peri-XRT) chemotherapy or hormone therapy.

Prostate Cancer
  • Procedure: Urodynamics Test
    90 Minute videotaped bladder function procedure involving pressure-monitoring catheters in bladder and rectum.
  • Behavioral: Questionnaire
    Survey of urinary function and quality-of-life (regarding daily living after surgical treatment for prostate cancer), taking 30 minutes to complete.
  • Prostatectomy
    Interventions:
    • Procedure: Urodynamics Test
    • Behavioral: Questionnaire
  • Prostatectomy After Radiation Therapy
    Interventions:
    • Procedure: Urodynamics Test
    • Behavioral: Questionnaire
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
May 2010
May 2010   (final data collection date for primary outcome measure)

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.
Male
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00901420
2006-0384
No
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
Not Provided
Study Chair: Ouida L. Westney, MD UT MD Anderson Cancer Center
M.D. Anderson Cancer Center
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP