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Efficacy of Penile Traction Therapy Using a Novel Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03389854
Recruitment Status : Completed
First Posted : January 4, 2018
Results First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Landon W. Trost, Mayo Clinic

Study Description
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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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 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
Actual Primary Completion Date : June 4, 2019
Actual Study Completion Date : June 4, 2019
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events at Baseline [ Time Frame: Baseline ]
    Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other

  2. Adverse Events at 3 Months [ Time Frame: 3 months ]
    Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other

  3. Adverse Events at 6 Months [ Time Frame: 6 months ]
    Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other

  4. Adverse Events at 9 Months [ Time Frame: 9 months ]
    Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other


Secondary Outcome Measures :
  1. Change in Penile Length to Corona [ Time Frame: 3 months, 6 months ]
    Stretched penile length measured in centimeters from pubic symphysis to glanular corona

  2. Change in Penile Length to Tip [ Time Frame: 3 months, 6 months ]
    Stretched penile length measured in centimeters from pubic symphysis to penile tip

  3. Change in Penile Curvature [ Time Frame: 3 months, 6 months ]
    Subjects received Trimix to achieve pharmacological erection and curvature was measured in degrees. A negative result denotes an improvement in curvature.

  4. Change Erectile Function [ Time Frame: 3 months, 6 months ]
    Self reported International Index of Erectile Function (IIEF) questionnaire for erectile dysfunction (ED) scored on a scale of <11 severe ED, 11-16 moderate ED, 17-25 mild ED, 26-30 no ED. Questionnaires were given to participants at baseline, 3 months and 6 months. Change in the score was reported for 3 months and 6 months.

  5. Change in Peyronie's Disease Psychological and Physical Domain on Peyronie's Disease Questionnaire (PDQ) [ Time Frame: Baseline, 3 months ]
    Self reported Peyronie's Disease questionnaire (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions with a total score range 0 to 24. Negative denotes improvement.

  6. Change in Peyronie's Disease Penile Pain Domain on Peyronie's Disease Questionnaire (PDQ) [ Time Frame: Baseline, 3 months ]
    Self reported Peyronie's Disease questionnaire penile pain scale range 0 (no pain) and 10 (extreme pain) on 3 questions with a total score range 0 to 30. Negative denotes improvement.

  7. Change in Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) [ Time Frame: Baseline, 3 month ]
    Self reported Peyronie's Disease questionnaire bother score range 0 (no issue or not at all bothered) and 4 (extremely bothered) on 4 questions with a total score range 0 to 16. Negative denotes improvement.

  8. Overall Treatment Satisfaction [ Time Frame: 3 months ]
    Self reported satisfaction of penile traction therapy on a scale of very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, very dissatisfied

  9. Ability to Achieve Sexual Intercourse [ Time Frame: 3 months ]
    Change from no to yes on the self reported standardized sexual encounter profile questions 2 "able to penetrate"

  10. Satisfaction With the RestoreX® Device to Alternative Forms of PTT [ Time Frame: 3 months ]
    Self reported satisfaction with how RestoreX® compares to other devices on a scale of much better, somewhat better, equal, somewhat worse, much worse

  11. Satisfaction With the RestoreX® Device to Alternative PD Therapies [ Time Frame: 3 months ]
    Subjects being treated for PD the first time were asked which therapies they would choose. Respondents could select more than 1 option so values equal greater than 100%.

  12. Ability to Achieve Sexual Intercourse [ Time Frame: 6 months ]
    Change from no to yes on the self reported standardized sexual encounter profile questions 2 "able to penetrate"


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Documents provided by Landon W. Trost, Mayo Clinic:
Study Protocol and Statistical Analysis Plan  [PDF] April 9, 2018

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Landon W. Trost, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03389854    
Other Study ID Numbers: 17-001283
First Posted: January 4, 2018    Key Record Dates
Results First Posted: August 12, 2020
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Penile Diseases
Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Male Urogenital Diseases