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Completed

NCT Number: NCT03389854

Efficacy of Penile Traction Therapy Using a Novel Device

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.

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Key information

Conditions

Penile Diseases Genital Diseases Genital Diseases, Male Male Urogenital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

RestoreX PTT - randomized and open label

Device

Penile traction therapy in the straight and bent positions

RestoreX PTT - open label phase only

Device

Penile traction therapy in the straight and bent positions

Primary outcomes

  1. Adverse Events at Baseline

    Time frame: 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

  2. Adverse Events at 3 Months

    Time frame: 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. Adverse Events at 6 Months

    Time frame: 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

  4. Adverse Events at 9 Months

    Time frame: 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

Secondary outcomes

  1. Change in Penile Length to Corona

    Time frame: 3 months, 6 months

    Stretched penile length measured in centimeters from pubic symphysis to glanular corona

  2. Change in Penile Length to Tip

    Time frame: 3 months, 6 months

    Stretched penile length measured in centimeters from pubic symphysis to penile tip

  3. Change in Penile Curvature

    Time frame: 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.

  4. Change Erectile Function

    Time frame: 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.

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

    Time frame: 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.

  6. Change in Peyronie's Disease Penile Pain Domain on Peyronie's Disease Questionnaire (PDQ)

    Time frame: 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.

  7. Change in Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)

    Time frame: 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.

  8. Overall Treatment Satisfaction

    Time frame: 3 months

    Self reported satisfaction of penile traction therapy on a scale of very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, very dissatisfied

  9. Ability to Achieve Sexual Intercourse

    Time frame: 3 months

    Change from no to yes on the self reported standardized sexual encounter profile questions 2 "able to penetrate"

  10. Satisfaction With the RestoreX® Device to Alternative Forms of PTT

    Time frame: 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

  11. Satisfaction With the RestoreX® Device to Alternative PD Therapies

    Time frame: 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%.

  12. Ability to Achieve Sexual Intercourse

    Time frame: 6 months

    Change from no to yes on the self reported standardized sexual encounter profile questions 2 "able to penetrate"

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Efficacy of Penile Traction Therapy Using a Novel Device: A Controlled, Single-blinded, Randomized Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 4, 2018
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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