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.

Study Overview

• Status: Completed
• Conditions: Penile Diseases
• Intervention / Treatment: Device: RestoreX PTT - open label phase only; Device: RestoreX PTT - randomized and open label

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
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Landon Trost, MD, Mayo Clinic

Publications and helpful links

General Publications

• Joseph J, Ziegelmann MJ, Alom M, Savage J, Köhler 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.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2017
• Primary Completion (Actual): June 4, 2019
• Study Completion (Actual): June 4, 2019

Study Registration Dates

• First Submitted: October 19, 2017
• First Submitted That Met QC Criteria: December 27, 2017
• First Posted (Actual): January 4, 2018

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 8, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Penile Diseases
• Other Study ID Numbers: 17-001283

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes