Efficacy of Penile Traction Therapy Using a Novel Device

Not Applicable

Completed

Conditions: Penile Diseases

Interventions: Device: RestoreX PTT - open label phase only
Device: RestoreX PTT - randomized and open label

Registration Number: NCT03389854

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 110

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group 1 - Control	RestoreX PTT - open label phase only	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.
Group 2 - PTT 1x daily x 3 months	RestoreX PTT - randomized and open label	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.
Group 3 - PTT 2x daily x 3 months	RestoreX PTT - randomized and open label	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.
Group 4 - PTT 3x daily x 3 months	RestoreX PTT - randomized and open label	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.

Primary Outcome Measures

Name	Time	Method
Adverse Events at 3 Months	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 9 Months	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
Adverse Events at Baseline	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 6 Months	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

Secondary Outcome Measures

Name	Time	Method
Overall Treatment Satisfaction	3 months	Self reported satisfaction of penile traction therapy on a scale of very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, very dissatisfied
Change in Penile Length to Corona	3 months, 6 months	Stretched penile length measured in centimeters from pubic symphysis to glanular corona
Ability to Achieve Sexual Intercourse	6 months	Change from no to yes on the self reported standardized sexual encounter profile questions 2 "able to penetrate"
Change in Penile Length to Tip	3 months, 6 months	Stretched penile length measured in centimeters from pubic symphysis to penile tip
Change in Penile Curvature	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	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)	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)	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)	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.
Satisfaction With the RestoreX® Device to Alternative Forms of PTT	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	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%.