Efficacy of Penile Traction Therapy Using a Novel Device

Mayo Clinic

Status: Completed

Conditions: Penile Diseases

Treatments: Device: RestoreX PTT - open label phase only; Device: RestoreX PTT - randomized and open label

Study type: Interventional

Funder types: Other

Identifiers

NCT03389854

17-001283

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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110 participants in 4 patient groups

Group 1 - Control

Sham Comparator group

Description:

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.

Treatment:

Device: RestoreX PTT - open label phase only

Group 2 - PTT 1x daily x 3 months

Experimental group

Description:

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.

Treatment:

Device: RestoreX PTT - randomized and open label

Group 3 - PTT 2x daily x 3 months

Experimental group

Description:

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.

Treatment:

Device: RestoreX PTT - randomized and open label

Group 4 - PTT 3x daily x 3 months

Experimental group

Description:

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.

Treatment:

Device: RestoreX PTT - randomized and open label