Efficacy of Penile Traction Therapy Using a Novel Device

• 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: Mayo Clinic
• Information provided by (Responsible Party): Landon W. Trost, Mayo Clinic

Tracking Information

• First Submitted Date: October 19, 2017
• First Posted Date: January 4, 2018
• Results First Submitted Date: April 23, 2020
• Results First Posted Date: August 12, 2020
• Last Update Posted Date: August 12, 2020
• Actual Study Start Date: October 2, 2017
• Actual Primary Completion Date: June 4, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 23, 2020)

• 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
• 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
• 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
• 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

Original Primary Outcome Measures (submitted: December 27, 2017)

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

Current Secondary Outcome Measures (submitted: April 23, 2020)

• Change in Penile Length to Corona [ Time Frame: 3 months, 6 months ]
  Stretched penile length measured in centimeters from pubic symphysis to glanular corona
• Change in Penile Length to Tip [ Time Frame: 3 months, 6 months ]
  Stretched penile length measured in centimeters from pubic symphysis to penile tip
• 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.
• 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.
• 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.
• 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.
• 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.
• 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
• 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"
• 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
• 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%.
• 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"

Original Secondary Outcome Measures (submitted: December 27, 2017)

• 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy of Penile Traction Therapy Using a Novel Device
• Official Title: Efficacy of Penile Traction Therapy Using a Novel Device: A Controlled, Single-blinded, Randomized Trial
• 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.
• 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
• Study Phase: Not Applicable

Study Design

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

• Condition: Penile Diseases

Intervention

• 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

Study Arms

• 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

Publications *

• Joseph J, Ziegelmann MJ, Alom M, Savage J, Kohler TS, Trost L. Outcomes of RestoreX Penile Traction Therapy in Men With Peyronie's Disease: Results From Open Label and Follow-up Phases. J Sex Med. 2020 Dec;17(12):2462-2471. doi: 10.1016/j.jsxm.2020.10.003. Epub 2020 Nov 20.
• Ziegelmann M, Savage J, Toussi A, Alom M, Yang D, Kohler T, Trost L. Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial. J Urol. 2019 Sep;202(3):599-610. doi: 10.1097/JU.0000000000000245. Epub 2019 Aug 8.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 23, 2020): 110
• Original Estimated Enrollment (submitted: December 27, 2017): 100
• Actual Study Completion Date: June 4, 2019
• Actual Primary Completion Date: June 4, 2019 (Final data collection date for primary outcome measure)

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
• Diabetes mellitus with evidence of end-organ damage (peripheral neuropathy, retinopathy, chronic kidney disease stage III or higher)

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03389854
• Other Study ID Numbers: 17-001283
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Landon W. Trost, Mayo Clinic
• Original Responsible Party: Same as current
• Current Study Sponsor: Mayo Clinic
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Landon Trost, MD; Mayo Clinic

• PRS Account: Mayo Clinic
• Verification Date: August 2020