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Efficacy of Penile Traction Therapy Using a Novel Device

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ClinicalTrials.gov Identifier: NCT03389854
Recruitment Status : Active, not recruiting
First Posted : January 4, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Landon W. Trost, Mayo Clinic

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 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.

Condition or disease Intervention/treatment Phase
Penile Diseases Device: RestoreX PTT - randomized and open label Device: RestoreX PTT - open label phase only Not Applicable

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 therapies for PD include repeated penile injections with bacterial enzymes and surgery. However, these therapies are expensive and in some cases result in permanent reductions in penile length and sensation. Penile traction therapy (PTT) is a relatively newer treatment which has been proposed as a treatment for PD with preliminary data suggesting a potential role. However, currently available PTT devices are primarily designed for penile lengthening and have many significant limitations including a requirement of use for 9 hours daily and significant difficulties in personal application. Given these limitations, a new penile traction device (RestoreX® ) was created and funded through Mayo Ventures and was specifically designed to treat men with PD. The primary objective of the current study is to evaluate safety of the device using various dosing schedules, with secondary endpoints designed to assess efficacy and subjective outcomes. To accomplish the study, a population of men from Mayo Clinic with PD will be enrolled and will be randomized to utilize the device for varying amounts of time. Outcomes will be assessed at 3, 6, and 9 months, and results are to be used with the intent to publish in a scientific journal.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Men will be randomized into one of four groups: no traction therapy, penile traction 30 minutes once daily, penile traction 30 minutes twice daily, and penile traction 30 minutes three times daily. This treatment will continue for 3 months, after which men will enter an open label phase for 3 months. Primary and secondary outcomes will be evaluated at the completion of the 3 month and 6 month time points. Additional AEs will be assessed at 9 months after study initiation.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Objective outcomes including penile length and curvature will be masked for the investigator and outcome assessor by obtaining photographs of the penis in the lateral and dorsal planes. Curvatures will also be assessed by a clinician in the case where photographs are not able to be obtained or if the participant refuses photographs. These will be assessed without any knowledge as to which grouping the patient is located by two independent reviewers. If there are differences >5 degrees (curvature), or 0.5 cm (length), a 3rd individual will mediate the difference.
Primary Purpose: Basic Science
Official Title: Efficacy of Penile Traction Therapy Using a Novel Device: A Controlled, Single-blinded, Randomized Trial
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : August 30, 2019

Arm Intervention/treatment
Sham Comparator: Group 1 - Control
No treatment will be administered for the initial 3 months. This are is necessary as Peyronie's disease may result in changes in length and curvature as a function of the disease process. After the 3 month period of time, this group will enter an open label phase where they may utilize a penile traction device if desired.
Device: RestoreX PTT - open label phase only
Penile traction therapy in the straight and bent positions

Experimental: Group 2 - PTT 1x daily x 3 months
Men will utilize penile traction therapy for 30 minutes once daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
Device: RestoreX PTT - randomized and open label
Penile traction therapy in the straight and bent positions

Experimental: Group 3 - PTT 2x daily x 3 months
Men will utilize penile traction therapy for 30 minutes twice daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
Device: RestoreX PTT - randomized and open label
Penile traction therapy in the straight and bent positions

Experimental: Group 4 - PTT 3x daily x 3 months
Men will utilize penile traction therapy for 30 minutes three times daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
Device: RestoreX PTT - randomized and open label
Penile traction therapy in the straight and bent positions




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as reported by participants and evaluated based on physical examination. [ Time Frame: From baseline to 9 months ]
    Safety as assessed through investigator or individual reporting of adverse events and physical examination with the RestoreX device when used 30 min 1x, 2x, 3x per day and in an open label fashion


Secondary Outcome Measures :
  1. Stretched penile length - randomized phase [ Time Frame: 3 months duration - from time 0 to 3 months ]
    Compare changes in stretched penile length following completion of 3 months of RestoreX therapy

  2. Penile curvature - randomized phase [ Time Frame: 3 months duration - from time 0 to 3 months ]
    Compare changes in penile curvature following completion of 3 months of RestoreX therapy

  3. Stretched penile length - open label phase [ Time Frame: 3 months duration - from 3 months after initiation to 6 months ]
    Compare changes in stretched penile length following completion of the open label phase (beginning 3 months after study initiation and continuing until 6 months) of RestoreX therapy

  4. Penile curvature - open label phase [ Time Frame: 3 months duration - from 3 months after initiation to 6 months ]
    Compare changes in penile curvature following completion of the open label phase (beginning 3 months after study initiation and continuing until 6 months) of RestoreX therapy

  5. Penile curvature - randomized and open label phase [ Time Frame: 6 months duration - from baseline to 6 months ]
    Compare changes in penile curvature from baseline until end of open-label phase

  6. Penile length - randomized and open label phase [ Time Frame: 6 months duration - from baseline to 6 months ]
    Compare changes in penile length from baseline until end of open-label phase

  7. Subjective questionnaire outcomes [ Time Frame: Baseline, 3 months, 6 months ]
    Compare outcomes of subjective responses to the Peyronie's disease questionnaire (PDQ)

  8. Subjective outcome of erectile function with IIEF [ Time Frame: Baseline, 3 months, 6 months ]
    Compare outcomes of the International Index of Erectile Function Questionnaire

  9. Subjective outcome of erectile function with SEP2 and 3 [ Time Frame: Baseline, 3 months, 6 months ]
    Compare outcomes of subjective reporting of the standardized sexual encounter profile questions 2 and 3

  10. Comparison to other treatments [ Time Frame: 3 months, 6 months ]
    Compare satisfaction with RestoreX to alternative forms of penile traction therapy and other Peyronie's disease therapies through use of a non-standardized set of questions.

  11. Subjective reporting of penile length [ Time Frame: Baseline, 3 months, 6 months ]
    Comparison of changes in penile length at various time points and among treatment arms

  12. Subjective reporting of penile curvature [ Time Frame: Baseline, 3 months, 6 months ]
    Comparison of changes in penile curvature at various time points and among treatment arms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  • Diabetes mellitus with evidence of end-organ damage (peripheral neuropathy, retinopathy, chronic kidney disease stage III or higher)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389854


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Landon Trost, MD Mayo Clinic
  Study Documents (Full-Text)

Documents provided by Landon W. Trost, Mayo Clinic:

Responsible Party: Landon W. Trost, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03389854     History of Changes
Other Study ID Numbers: 17-001283
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: September 11, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Additional relevant MeSH terms:
Penile Diseases
Genital Diseases, Male