NCT03500419|CompletedResultsFDA Device
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Sponsor study identifier
interventional
82
1 country
1
Study Start
March 23, 2018
Actual (reported)Primary Completion
December 28, 2020
Actual (reported)Study Completion
December 28, 2020
Actual (reported)The objective of the current study is to evaluate the efficacy of a novel, class I (ie. lowest risk, clinical studies not required) medical penile traction device in preventing loss of penile length in men undergoing robotic-assisted prostatectomy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 28, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 23, 2018
Actual (reported)April 9, 2018
Actual (reported)April 18, 2018
Actual (reported)December 28, 2020
Actual (reported)December 28, 2020
Actual (reported)October 20, 2021
Actual (reported)Change in Penile Length
Stretched penile length measured in centimeters from pubic symphysis to glanular corona
Baseline, 6 months
Erectogenic Therapy Use
6 months
Intracavernosal Injections
6 months
Change in Erectile Function Domain of International Index of Erectile Function (IIEF)
baseline, 6 months
Change in Intercourse Satisfaction Domain of International Index of Erectile Function (IIEF)
Baseline, 6 months
Change in Overall Satisfaction Domain of International Index of Erectile Function (IIEF)
Baseline, 6 months
No treatment will be administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes.
Men will utilize penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy. Men will remain in this phase for a period of 5 months.
PTT - Penile traction therapy in the straight position.
Control group. No treatment will be given for the 6 months post-prostatectomy
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Matthew Ziegelmann, MD
Mayo Clinic
82 participants (actual enrollment reported by the registry).
First Submitted
April 9, 2018
First Posted
April 18, 2018
Study Start
March 23, 2018
Actual (reported)Decision Aids to Improve Knowledge in Patients With Prostate Cancer
Contact the study team to confirm eligibility.
Primary Completion
December 28, 2020
Actual (reported)Study Completion
December 28, 2020
Actual (reported)Last Updated
October 20, 2021
Results First Posted
October 20, 2021
Record last verified: 2021-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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