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.
Traction therapy Using device https://clinicaltrials.gov/ Sponsor: Mayo Clinic
ANDROPEYRONIE is the only FDA registered and also patented Penile extender device offered in the United States. Efficacy of Penile Traction treatment Using andropenis tool https://clinicaltrials.gov/ Sponsor: Mayo Clinic
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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 problem of the penis, influencing 1– 13% of the United States male populace. The condition results in penile curvature and substantial psychosocial trouble. Current preferred therapies for PD consist of duplicated penile shots with bacterial enzymes as well as surgery. Nevertheless, these therapies are pricey as well as in many cases lead to irreversible reductions in penile lengthening and also feeling. Penile traction therapy PTT (andropeyeonie) is a fairly newer treatment which has actually been proposed as a treatment for PD with preliminary data recommending a potential function. However, currently available PTT tools are mainly created for penile lengthening and also have several substantial restrictions including a need of use for 9 hours day-to-day and significant problems in individual application. Provided these constraints, a new penile traction tool (Andropenis) was created as well as funded with ANDROMEDICAL as well as was particularly designed to treat guys with PD. The main objective of the existing study is to evaluate safety and security of the device utilizing various application timetables, with additional endpoints made to analyze efficiency and subjective results. To accomplish the study, a population of guys from Mayo Clinic with PD will be enlisted and will be randomized to use the gadget for differing amounts of time. End results will certainly be analyzed at 3, 6, and 9 months, and also outcomes are to be used with the intent to publish in a scientific journal.
Study Type: Interventional (Clinical Trial) Estimated Enrollment: 120 individuals Allocation: Randomized Intervention Model: Factorial Assignment Intervention Model Description: Men will certainly be randomized right into one of 4 groups: no traction treatment, penile grip ( ANDROPEYRONIE) 30 mins once daily, penile traction ( ANDROPEYRONIE) 30 mins two times daily, and penile traction 30 mins three times daily. This therapy will proceed for 3 months, after which guys will certainly enter an open tag stage for 3 months. Primary and secondary results will be examined at the completion of the 3 month as well as 6 month time factors. Additional AEs will be assessed at 9 months after research initiation. Concealing: Double (Investigator, Outcomes Assessor) Masking Description: Objective end results including penile size as well as curvature will certainly be concealed for the private investigator as well as outcome assessor by getting pictures of the penis in the side as well as dorsal airplanes. Curvatures will certainly additionally be analyzed by a clinician in the case where pictures are unable to be acquired or if the individual rejects pictures. These will be assessed without any understanding as to which organizing the individual is located by two independent reviewers. If there are differences > 5 degrees (curvature), or 0.5 cm (size), a 3rd individual will certainly moderate the distinction. 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 certainly be administered for the preliminary 3 months This are is needed as Peyronie’s condition may lead to changes in size and curvature as a function of the condition process. After the 3 month amount of time, this team will enter an open tag stage where they may utilize a penile traction tool (andropeyronie) if desired.
xperimental: Group 2– PTT 1x daily x 3 months
Guy will certainly use penile grip therapy () for half an hour once daily for the initial 3 months After this stage is completed, they will go into an open label phase for 3 months where they might use the tool as much or as little as desired.
Speculative: Group 3– PTT 2x daily x 3 months.
Men will certainly utilize penile grip treatment Peyronie’s disease (andropeyronie) for 30 minutes two times daily for the first 3 months. After this phase is finished, they will go into an open tag stage for 3 months where they may utilize the device as much or as little as preferred.
Experimental: Group 4– PTT 3x everyday x 3 months.
Male will use penile traction therapy (andropeyronie) for 30 mins 3 times daily for the initial 3 months. Hereafter stage is finished, they will go into an open tag phase for 3 months where they may make use of the gadget as much or as little as preferred.
Primary Outcome Measures :
Variety of individuals with treatment-related damaging events as reported by participants and reviewed based on physical examination. [Timespan: From standard to 9 months] Security as examined through investigator or private coverage of adverse events and also physical exam with the (andropeyronie) tool when made use of 30 minutes 1x, 2x, 3x daily and also in an open tag fashion
Secondary Outcome Measures:.
Extended penile length Penile curvature (andropeyronie)– randomized phase [Period: 3 months duration– from time 0 to 3 months] Compare adjustments in extended penile size following conclusion of 3 months of (andropeyronie) therapy.
Penile curvature– randomized stage [Time Frame: 3 months period– from time 0 to 3 months] Compare modifications in penile curvature complying with completion of 3 months of (andropeyronie) treatment.
Extended penile size (andropeyronie)– open tag phase [Amount of time: 3 months period– from 3 months after initiation to 6 months] Contrast modifications in stretched penile length adhering to completion of the open label stage (beginning 3 months after research initiation and also proceeding up until 6 months) of (andropeyronie) treatment.
Penile curvature— open label stage [Time Frame: 3 months duration– from 3 months after initiation to 6 months] Compare adjustments in penile curvature following completion of the open label phase (beginning 3 months after research initiation and proceeding up until 6 months) of (andropeyronie) therapy
Penile curvature– randomized and also open label stage [Period: 6 months duration– from standard to 6 months] Compare changes in penile curvature from baseline until end of open-label stage
Penile length– randomized and open label stage [Amount of time: 6 months period– from baseline to 6 months] Compare modifications in penile size from baseline up until end of open-label stage
Subjective survey results [Amount Of Time: Baseline, 3 months, 6 months] Contrast results of subjective reactions to the Peyronie’s condition questionnaire (PDQ).
- Subjective end result of erectile function with IIEF [Time Frame: Baseline, 3 months, 6 months] Contrast end results of the International Index of Erectile Function Questionnaire
Subjective result of erectile function with SEP2 and 3 [Period: Baseline, 3 months, 6 months] Compare end results of subjective reporting of the standardized sexual encounter profile concerns 2 as well as 3
Comparison to other therapies [Time Frame: 3 months, 6 months] Compare contentment with (andropeyronie) to alternate forms of penile traction treatment and also various other Peyronie’s disease treatments via use of a non-standardized collection of concerns.
Subjective coverage of penile size [Amount Of Time: Baseline, 3 months, 6 months] Contrast of changes in penile length at numerous time factors as well as among therapy arms
Subjective coverage of penile curvature [Amount Of Time: Baseline, 3 months, 6 months] Comparison of modifications in penile curvature at different time points as well as among therapy arms
CLINICAL PEYRONIE EXTENDER A basic & efficient penis curvature adjustment.
@andropeyronie Correction of rounded penis: up to 60% modification of penile curvature triggered by Peyronie’s illness
ANDROPEYRONIE is the only FDA signed up as well as patented penis extender gadget sold in the United States
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