Efficacy of Penile Traction Therapy Using a Novel Device

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of Penile Traction Therapy Using a Novel Device: A Controlled, Single-blinded, Randomized Trial

Conditions
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Penile Diseases

Intervention / Treatment
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* Device: RestoreX PTT - randomized and open label
* Device: RestoreX PTT - open label phase only


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Group 1 - Control<br>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<br>* Penile traction therapy in the straight and bent positions<br>|
| Experimental: Group 2 - PTT 1x daily x 3 months<br>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<br>* Penile traction therapy in the straight and bent positions<br>|
| Experimental: Group 3 - PTT 2x daily x 3 months<br>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<br>* Penile traction therapy in the straight and bent positions<br>|
| Experimental: Group 4 - PTT 3x daily x 3 months<br>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<br>* Penile traction therapy in the straight and bent positions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events at 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 | Baseline | 
| Adverse Events at 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 months | 
| Adverse Events at 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 | 6 months | 
| Adverse Events at 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 | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Penile Length to Corona | Stretched penile length measured in centimeters from pubic symphysis to glanular corona | 3 months, 6 months | 
| Change in Penile Length to Tip | Stretched penile length measured in centimeters from pubic symphysis to penile tip | 3 months, 6 months | 
| Change in Penile Curvature | Subjects received Trimix to achieve pharmacological erection and curvature was measured in degrees. A negative result denotes an improvement in curvature. | 3 months, 6 months | 
| Change Erectile Function | 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. | 3 months, 6 months | 
| Change in Peyronie's Disease Psychological and Physical Domain on Peyronie's Disease Questionnaire (PDQ) | 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. | Baseline, 3 months | 
| Change in Peyronie's Disease Penile Pain Domain on Peyronie's Disease Questionnaire (PDQ) | 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. | Baseline, 3 months | 
| Change in Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) | 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. | Baseline, 3 month | 
| Overall Treatment Satisfaction | Self reported satisfaction of penile traction therapy on a scale of very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, very dissatisfied | 3 months | 
| Ability to Achieve Sexual Intercourse | Change from no to yes on the self reported standardized sexual encounter profile questions 2 able to penetrate | 3 months | 
| Satisfaction With the RestoreX® Device to Alternative Forms of PTT | Self reported satisfaction with how RestoreX® compares to other devices on a scale of much better, somewhat better, equal, somewhat worse, much worse | 3 months | 
| Satisfaction With the RestoreX® Device to Alternative PD Therapies | 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%. | 3 months | 
| Ability to Achieve Sexual Intercourse | Change from no to yes on the self reported standardized sexual encounter profile questions 2 able to penetrate | 6 months |