Clinical trial NCT03389854: Efficacy of Penile Traction Therapy Using a Novel Device
Official title: Efficacy of Penile Traction Therapy Using a Novel Device: A Controlled, Single-blinded, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Penile Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 110
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Adverse Events at Baseline
timeFrame: Baseline
measure: Adverse Events at 3 Months
timeFrame: 3 months
measure: Adverse Events at 6 Months
timeFrame: 6 months
measure: Adverse Events at 9 Months
timeFrame: 9 months
Secondary outcomes:
measure: Change in Penile Length to Corona
timeFrame: 3 months, 6 months
measure: Change in Penile Length to Tip
timeFrame: 3 months, 6 months
measure: Change in Penile Curvature
timeFrame: 3 months, 6 months
measure: Change Erectile Function
timeFrame: 3 months, 6 months
measure: Change in Peyronie's Disease Psychological and Physical Domain on Peyronie's Disease Questionnaire (PDQ)
timeFrame: Baseline, 3 months
measure: Change in Peyronie's Disease Penile Pain Domain on Peyronie's Disease Questionnaire (PDQ)
timeFrame: Baseline, 3 months
measure: Change in Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)
timeFrame: Baseline, 3 month
measure: Overall Treatment Satisfaction
timeFrame: 3 months
measure: Ability to Achieve Sexual Intercourse
timeFrame: 3 months
measure: Satisfaction With the RestoreX® Device to Alternative Forms of PTT
timeFrame: 3 months
measure: Satisfaction With the RestoreX® Device to Alternative PD Therapies
timeFrame: 3 months
measure: Ability to Achieve Sexual Intercourse
timeFrame: 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Landon Trost, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.