Urodynamic Evaluation in Post-radiation Salvage Prostatectomy Patients

NCT00901420 | Terminated

• 1 other identifier: 2006-0384
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate; Urodynamic Evaluation; Prostatectomy; Salvage prostatectomy; Bladder compliance; Radiation Therapy; External beam radiation therapy; Quality-of-life

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Study Arms (2)

Prostatectomy

Procedure: Urodynamics Test; Behavioral: Questionnaire

Prostatectomy After Radiation Therapy

Procedure: Urodynamics Test; Behavioral: Questionnaire

Interventions

Urodynamics Test PROCEDURE

90 Minute videotaped bladder function procedure involving pressure-monitoring catheters in bladder and rectum.

Prostatectomy; Prostatectomy After Radiation Therapy

Questionnaire BEHAVIORAL

Survey of urinary function and quality-of-life (regarding daily living after surgical treatment for prostate cancer), taking 30 minutes to complete.

Prostatectomy; Prostatectomy After Radiation Therapy

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Men who have undergone radical prostatectomy, via an open or minimally invasive approach, as primary treatment for a diagnosis of prostate cancer.
• Men who have undergone salvage prostatectomy for recurrence after first-line radiation therapy for prostate cancer.
• 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.

You may not qualify if:

• Men who underwent other primary or secondary treatments for prostate cancer--hormone therapy as only treatment, cryosurgery, adjuvant radiation after prostatectomy
• Men with a history of neurogenic bladder, as demonstrated by previous urodynamics.
• 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.
• Men who underwent additional reconstructive procedures at the time of or subsequent to prostatectomy, including augmentation, urethral sling, or urinary diversion.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ouida L. Westney, MD

  UT MD Anderson Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2009
• First Posted: May 13, 2009
• Study Start: June 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

US (1)