Urodynamic Evaluation in Post-radiation Salvage Prostatectomy Patients
NCT ID: NCT00901420
Last Updated: 2012-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
2 participants
OBSERVATIONAL
2007-06-30
2010-05-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Prostatectomy
Urodynamics Test
90 Minute videotaped bladder function procedure involving pressure-monitoring catheters in bladder and rectum.
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
Urodynamics Test
90 Minute videotaped bladder function procedure involving pressure-monitoring catheters in bladder and rectum.
Questionnaire
Survey of urinary function and quality-of-life (regarding daily living after surgical treatment for prostate cancer), taking 30 minutes to complete.
Interventions
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Urodynamics Test
90 Minute videotaped bladder function procedure involving pressure-monitoring catheters in bladder and rectum.
Questionnaire
Survey of urinary function and quality-of-life (regarding daily living after surgical treatment for prostate cancer), taking 30 minutes to complete.
Eligibility Criteria
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Inclusion Criteria
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
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
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ouida L. Westney, MD
Role: STUDY_CHAIR
UT MD Anderson Cancer Center
Locations
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UT MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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UT MD Anderson Cancer Center website
Other Identifiers
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2006-0384
Identifier Type: -
Identifier Source: org_study_id