Status:
COMPLETED
Efficacy of Penile Traction Therapy Using a Novel Device
Lead Sponsor:
Mayo Clinic
Conditions:
Penile Diseases
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
This clinical trial is designed to assess the safety, dosing, and preliminary efficacy of a novel penile traction device on correcting deformities relating to Peyronie's disease, a condition which res...
Detailed Description
Peyronie's disease (PD) is a fibrotic condition of the penis, affecting 1-13% of the US male population. The disease results in penile curvature and significant psychosocial bother. Current preferred ...
Eligibility Criteria
Inclusion
- Diagnosis of Peyronie's disease
- Current 30 degree curvature in a single plane (i.e. 20 degrees up, 15 degrees left would not be a candidate)
- Not undergoing other therapies for PD currently
Exclusion
- Stretched penile length \<7 cm
- Prisoners
- Erectile dysfunction unresponsive to phosphodiesterase-5 inhibitors or intracavernosal injection therapies
- Diabetes mellitus with evidence of end-organ damage (peripheral neuropathy, retinopathy, chronic kidney disease stage III or higher)
Key Trial Info
Start Date :
October 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2019
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT03389854
Start Date
October 2 2017
End Date
June 4 2019
Last Update
August 12 2020
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905