An observational study in Prostate Cancer, sponsored by University of Campinas, Brazil. Completed at 1 site in Brazil. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-24.
Sponsored by University of Campinas, Brazil · Observational
Prostate biopsy was offered to 47 consecutive patients with prostate-specific antigen (PSA) over 4 ng/dl or suspicious digital rectal examination (DRE) of whom 16 had undergone a biopsy. Comprehensive validated questionnaires at TIME 0 (pre-biopsy), TIME 1 (before diagnosis, 20 days after biopsy) and TIME 2 (after diagnosis, 40 days after biopsy) accessed patients' erectile (IIEF-5) and voiding (IPSS) functions, Beck scales measured anxiety (BAI), hopelessness (BHS) and depression (BDI), added to the emotional thermometers including five visual analog scales for distress, anxiety, depression, anger and need for help. Mann-Whitney or Friedman tests were obtained among times and studied variables.
A prospective, longitudinal and observational study in which the sexually active patients were evaluated in the Urology Department of the city of Paulínia, submitted to biopsy guided by transrectal ultrasound after ethics committee approval (355.357).
Consecutive patients who were attended by urologist and present prostate cancer suspicions (PSA> 4 ng / dL and/or rectal examination (TR) were submitted a BXP. They were evaluated at three different moments of the biopsy:
Validated instruments were applied - IIEF-5 (erectile function); - IPSS (voiding function); - Beck scales - BAI (anxiety), BHS (hopelessness), BDI (depression); and - Emotional thermometers.
The comparison among the moments (T0, T1, and T2) was performed through Friedman (analysis of variance) for repeated measures with the variables transformed in stations. The comparison between patients and variables was performed using the Mann-Whitney test. The sample power was calculated and the level of significance considered was 5%.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 47 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University of Campinas, Brazil is the lead sponsor of 166 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients who were attended by a urologist with prostate biopsy indication.
Exclusion Criteria:
Interview
Erectile Function
International Index of Erectile Function - IIEF-5 index (range 0-25; higher better)
Time frame: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
Voiding Function
International Prostatic Symptoms Score - IPSS (range 0-35; higher worse)
Time frame: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
Beck scale
Beck Anxiety Index - BAI (0-63; higher worse)
Time frame: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
Emotional thermometers
Thermometer score (range 0-10; higher worse)
Time frame: Change from time of biopsy indication (T0) compared to 20 days after procedure (T1) and 20 days after pathological report result (T2, 40 days)
Plan to share: Undecided
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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University of Campinas, Brazil