Efficacy of Penile Traction Therapy Using a Novel Device

Completed · Not applicable

Conditions studied: Penile Diseases

In brief

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 results in penile curvature and length loss. The trial is designed as a randomized, placebo-controlled study with men randomized to receiving no therapy or penile traction therapy 30 minutes once, twice, or three times daily. The study will occur over a 3 month period, after which an open label phase for 3 months will be conducted. Final assessments for adverse effects will also be assessed at 9 months.

Key facts

Study ID

NCT03389854

Run by

Mayo Clinic

People needed

110

Starts

2017-10-02

Expected to finish

2019-06-04

Last updated by the study team

2020-08-12

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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