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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

October 19, 2017
January 4, 2018
September 11, 2018
October 2, 2017
May 30, 2019   (Final data collection date for primary outcome measure)
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
Number of participants with treatment-related adverse events as reported by participants and evaluated based on physical examination. [ Time Frame: 3, 6, and 9 months after initiation ]
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
Complete list of historical versions of study NCT03389854 on ClinicalTrials.gov Archive Site
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Subjective questionnaire outcomes [ Time Frame: Baseline, 3 months, 6 months ]
    Compare outcomes of subjective responses to the Peyronie's disease questionnaire (PDQ)
  • Subjective outcome of erectile function with IIEF [ Time Frame: Baseline, 3 months, 6 months ]
    Compare outcomes of the International Index of Erectile Function Questionnaire
  • 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
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Subjective questionnaire outcomes [ Time Frame: Baseline, 3 months, 6 months ]
    Compare outcomes of subjective responses to the Peyronie's disease questionnaire (PDQ)
  • Subjective outcome of erectile function [ Time Frame: Baseline, 3 months, 6 months ]
    Compare outcomes of the International Index of Erectile Function Questionnaire
  • Subjective outcome of erectile function [ Time Frame: Baseline, 3 months, 6 months ]
    Compare outcomes of subjective reporting of the standardized sexual encounter profile questions 2 and 3
  • 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.
  • 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
  • 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
Not Provided
Not Provided
 
Efficacy of Penile Traction Therapy Using a Novel Device
Efficacy of Penile Traction Therapy Using a Novel Device: A Controlled, Single-blinded, Randomized Trial
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.
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.
Interventional
Not Applicable
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
Penile Diseases
  • Device: RestoreX PTT - randomized and open label
    Penile traction therapy in the straight and bent positions
  • Device: RestoreX PTT - open label phase only
    Penile traction therapy in the straight and bent positions
  • 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.
    Intervention: Device: RestoreX PTT - open label phase only
  • 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.
    Intervention: Device: RestoreX PTT - randomized and open label
  • 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.
    Intervention: Device: RestoreX PTT - randomized and open label
  • 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.
    Intervention: Device: RestoreX PTT - randomized and open label
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
117
100
August 30, 2019
May 30, 2019   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Male
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT03389854
17-001283
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
Plan to Share IPD: No
Landon W. Trost, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Landon Trost, MD Mayo Clinic
Mayo Clinic
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP