Decreasing Morbidity through Exposure to the Prostate Biopsy Gun and Distraction during Prostate Biopsy
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 11-008026
Sponsor Protocol Number: 11-008026
About this study
This study will attempt to identify potential non-pharmacologic interventions that will decrease the morbidity associated with prostate biopsy.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Men will be eligible for this study if they were referred for a non-saturation office prostate biopsy to rule out the presence of prostate cancer in the setting of an elevated PSA or abnormal DRE. These men will be identified from the prostate biopsy schedule and from those added to the schedule that day. There are no age restrictions, though likely the age range will go from 40-80 yrs. Health status will not be separately evaluated, but rather deemed adequate for men healthy enough to undergo prostate biopsy.
Inclusion Criteria:
Men will be eligible for this study if they were referred for a non-saturation office prostate biopsy to rule out the presence of prostate cancer in the setting of an elevated PSA or abnormal DRE. These men will be identified from the prostate biopsy schedule and from those added to the schedule that day.
Exclusion Criteria:
Exclusion criteria will include patients with: hearing impairment, previous biopsies, history of daily narcotic use, chronic prostatitis and chronic pelvic pain, pelvic floor tension myalgia, and other chronic pain syndromes, active anorectal disease, anxiety, depression and active urinary tract infection. Patients will also need to be proficient in English, with at least a 6th grade reading level.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Lance Mynderse, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available