Efficacy of Penile Traction Therapy Using andropeyronie device

ANDROPEYRONIE is the only FDA registered  and patented penis extender device sold in the US   

Efficacy of Penile Traction Therapy Using andropenis device https://clinicaltrials.gov/   Sponsor: Mayo Clinic 

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Brief Summary:

This clinical trial is designed to assess the safety, dosing, and preliminary efficacy of a novel penile traction device (andropeyronie) 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.

Condition or disease    Intervention/treatment    Phase      Penile Diseases   Device: ANDROPEYRONIE PTT - randomized and open label Device: ANDROPEYRONIE PTT - open label phase only   Not Applicable

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 (andropeyeonie) 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 (Andropenis) was created and funded through ANDROMEDICAL 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                  (Clinical Trial)                                    Estimated Enrollment : 120 participants   Allocation: Randomized   Intervention Model: Factorial Assignment   Intervention Model Description:  Men will be randomized into one of four groups: no traction therapy, penile traction (ANDROPEYRONIE) 30 minutes once daily, penile traction (ANDROPEYRONIE)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.   Masking:  Double (Investigator, Outcomes Assessor)   Masking Description:  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.   Primary Purpose:  Basic Science   Official Title: Efficacy of Penile Traction Therapy Using a ANDROPEYRONIE : A Controlled, Single-blinded, Randomized Trial     Actual Study Start Date : October 2, 2017     Estimated Primary Completion Date : April 30, 2019     Estimated Study Completion Date : April 30, 2019

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 (andropeyronie) if desired.

xperimental: Group 2 - PTT 1x daily x 3 months 

Men will utilize penile traction therapy (andropeyronie) 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.

Experimental: Group 3 - PTT 2x daily x 3 months 

Men will utilize penile traction therapy (andropeyronie) 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.

Experimental: Group 4 - PTT 3x daily x 3 months 

Men will utilize penile traction therapy (andropeyronie) 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.

Primary Outcome Measures :        

1. Number of participants with treatment-related adverse events as reported by participants and evaluated based on physical examination. [ Time Frame: From baseline to 9 months ]Safety as assessed through investigator or individual reporting of adverse events and physical examination with the (andropeyronie) device when used 30 min 1x, 2x, 3x per day and in an open label fashion
   Secondary Outcome Measures :        
2. Stretched penile length (andropeyronie)  - randomized phase [ Time Frame: 3 months duration - from time 0 to 3 months ]Compare changes in stretched penile length following completion of 3 months of (andropeyronie)  therapy
    
3. Penile curvature - randomized phase [ Time Frame: 3 months duration - from time 0 to 3 months ]Compare changes in penile curvature following completion of 3 months of (andropeyronie) therapy
    
4. Stretched penile length (andropeyronie)  - open label phase [ Time Frame: 3 months duration - from 3 months after initiation to 6 months ]Compare changes in stretched penile length following completion of the open label phase (beginning 3 months after study initiation and continuing until 6 months) of (andropeyronie) therapy
    
5. Penile curvature - open label phase [ Time Frame: 3 months duration - from 3 months after initiation to 6 months ]Compare changes in penile curvature following completion of the open label phase (beginning 3 months after study initiation and continuing until 6 months) of (andropeyronie) therapy
    
6. Penile curvature - randomized and open label phase [ Time Frame: 6 months duration - from baseline to 6 months ]Compare changes in penile curvature from baseline until end of open-label phase
    
7. Penile length - randomized and open label phase [ Time Frame: 6 months duration - from baseline to 6 months ]Compare changes in penile length from baseline until end of open-label phase
    
8. Subjective questionnaire outcomes [ Time Frame: Baseline, 3 months, 6 months ]Compare outcomes of subjective responses to the Peyronie's disease questionnaire (PDQ)
    
9. Subjective outcome of erectile function with IIEF [ Time Frame: Baseline, 3 months, 6 months ]Compare outcomes of the International Index of Erectile Function Questionnaire
    
10. Subjective outcome of erectile function with SEP2 and 3 [ Time Frame: Baseline, 3 months, 6 months ]Compare outcomes of subjective reporting of the standardized sexual encounter profile questions 2 and 3
     
11. Comparison to other treatments [ Time Frame: 3 months, 6 months ]Compare satisfaction with (andropeyronie) to alternative forms of penile traction therapy and other Peyronie's disease therapies through use of a non-standardized set of questions.
     
12. Subjective reporting of penile length [ Time Frame: Baseline, 3 months, 6 months ]Comparison of changes in penile length at various time points and among treatment arms
     
13. Subjective reporting of penile curvature [ Time Frame: Baseline, 3 months, 6 months ]Comparison of changes in penile curvature at various time points and among treatment arms