Efficacy of Penile Traction Therapy Using a Novel Device

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 17-001283
    NCT ID: NCT03389854
    Sponsor Protocol Number: 17-001283

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

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 us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Landon Trost, M.D.

Closed for enrollment

Contact information:

Leanne Sandieson

(507)293-2471

Sandieson.Leanne@mayo.edu

More information

Study Progress

This study has completed enrollment of targeted participants and currently is completing research activities including study intervention, specimen collection, testing and data analysis.

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20337812

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