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
  Purpose

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.


Condition Intervention
Prostate Cancer
Procedure: Urodynamics Test
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparison of Urodynamic Evaluation in Post-Radiation Salvage Prostatectomy Versus Prostatectomy-only Patients

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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.


Enrollment: 2
Study Start Date: June 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Prostatectomy 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 After Radiation Therapy 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.

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00901420

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Ouida L. Westney, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00901420     History of Changes
Other Study ID Numbers: 2006-0384
Study First Received: May 12, 2009
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Prostate
Urodynamic Evaluation
Prostatectomy
Salvage prostatectomy
Bladder compliance
Radiation Therapy
External beam radiation therapy
Quality-of-life

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014