Efficacy of Penile Traction Therapy Using a Novel Device

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

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 Criteria:

Stretched penile length <7 cm
Prisoners
Erectile dysfunction unresponsive to phosphodiesterase-5 inhibitors or intracavernosal injection therapies
Severely calcified penile plaques (>1 cm)
Diabetes mellitus with evidence of end-organ damage (peripheral neuropathy, retinopathy, chronic kidney disease stage III or higher)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Matthew Ziegelmann, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Matthew Ziegelmann, M.D.

Closed for enrollment

More information

Publications

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Clinical Trials