Efficacy of Penile Traction Therapy Using a Novel Device

NCT03389854 | Completed Results FDA Device

• 1 other identifier: 17-001283
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Penile Diseases

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Change in Penile Length to Corona

  3 months, 6 months

• Change in Penile Length to Tip

  3 months, 6 months

• Change in Penile Curvature

  3 months, 6 months

• Change Erectile Function

  3 months, 6 months

• Change in Peyronie's Disease Psychological and Physical Domain on Peyronie's Disease Questionnaire (PDQ)

  Baseline, 3 months

Study Arms (4)

Group 1 - Control

SHAM COMPARATOR

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

Group 2 - PTT 1x daily x 3 months

EXPERIMENTAL

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

Group 3 - PTT 2x daily x 3 months

EXPERIMENTAL

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

Group 4 - PTT 3x daily x 3 months

EXPERIMENTAL

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

Interventions

RestoreX PTT - randomized and open label DEVICE

Penile traction therapy in the straight and bent positions

Group 2 - PTT 1x daily x 3 months; Group 3 - PTT 2x daily x 3 months; Group 4 - PTT 3x daily x 3 months

RestoreX PTT - open label phase only DEVICE

Penile traction therapy in the straight and bent positions

Group 1 - Control

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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.

  PMID: 33223425 DERIVED

• 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.

  PMID: 30916626 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Penile Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. Landon Trost
• Organization: Mayo Clinic

Trost.Landon@mayo.edu

507-284-3728

Study Officials

• Landon Trost, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: January 4, 2018
• Study Start: October 2, 2017
• Primary Completion: June 4, 2019
• Study Completion: June 4, 2019
• Last Updated: August 12, 2020
• Results First Posted: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)