Penile Length Maintenance Post-Prostatectomy
1 other identifier
interventional
82
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 23, 2018
CompletedFirst Submitted
Initial submission to the registry
April 9, 2018
CompletedFirst Posted
Study publicly available on registry
April 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2020
CompletedResults Posted
Study results publicly available
October 20, 2021
CompletedOctober 20, 2021
September 1, 2021
2.8 years
April 9, 2018
September 28, 2021
September 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Penile Length
Stretched penile length measured in centimeters from pubic symphysis to glanular corona
Baseline, 6 months
Secondary Outcomes (5)
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
Study Arms (2)
Control
ACTIVE COMPARATORNo treatment will be administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes.
Group AB - PTT 1-2x daily x 5-7 days/week x 5 months
EXPERIMENTALMen 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.
Interventions
PTT - Penile traction therapy in the straight position.
Control group. No treatment will be given for the 6 months post-prostatectomy
Eligibility Criteria
You may qualify if:
- Undergoing robotic prostatectomy
- Seen in the post-prostatectomy rehab clinic
You may not qualify if:
- Urethral complications from prostatectomy at the time of baseline visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Matthew (Matt) J. Ziegelmann, M.D.
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Ziegelmann, MD
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 9, 2018
First Posted
April 18, 2018
Study Start
March 23, 2018
Primary Completion
December 28, 2020
Study Completion
December 28, 2020
Last Updated
October 20, 2021
Results First Posted
October 20, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share