If you live in or near Rochester, Minn. and fit their criteria you should seriously consider signing up.
The Effectiveness of Using a Novel Penile Traction Device - Mayo Clinic (http://www.mayo.edu/research/clinical-trials/cls-20337812#eligibility)
The purpose of this study is to evaluate the safety and efficacy of a new penile traction device on improving penile curvature in men with Peyronie's disease. The study will involve randomizing patients to use the device 30 minutes once, twice, or three times daily and will compare outcomes with no treatment.
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More information from the Dr running the trial:
Back to your original question though. This would take 3 visits from patients: the initial visit (probably 2-3 hours total here), the 3 month visit (1-1.5 hours), and the 6 month visit (1-1.5 hours). That would be it.
I'm including some information from our protocol below:
Inclusion Criteria
• Males with previously diagnosed Peyronies Disease
• >18 years old
Exclusion Criteria
• Prisoners
• Curvatures <30 degrees
• Stretched penile length <7 cm
• Currently undergoing intralesional injections for Peyronies Disease
• Erectile dysfunction (ED) unresponsive to phosphodiesterase-5 inhibitors or intracavernosal injection therapies
• Severely calcified penile plaques (> 1 cm)
• Diabetes mellitus with evidence of end-organ damage (peripheral neuropathy, retinopathy, CKD stage III or higher, etc.)
Protocol:
1st visit
• Description of study and consent; receives initial questionnaires and curvature assessment in office.
• Randomized to one of 4 arms: control (no treatment), traction 30 min 1x/daily, traction 30 min 2x/daily, traction 30 min 3x/daily
• Daily diary is kept until next visit
2nd visit - 3 months after initial
• Repeat curvature assessment
• Additional questionnaires
• Begin open-label phase: patients allowed to utilize the device as much or as little as they would like. Those in the control arm are given a device to use at this point.
3rd visit - 6 months after initial
• Final curvature assessment
• Additional questionnaires
9 months after initial
• Final contact to ask about adverse effects
Prior to enrollment, we would want to make sure that all potential participants were off of any other therapy for at least 4 weeks (to make sure it doesn't impact the outcomes).
Hope this helps, and please feel free to email me any time with any follow-up questions. Thanks again for the exposure of the study - very gracious of you. I believe we've enrolled approximately 16-18 or so as of now (we have openings for up to 100). I think we started enrolling 1-2 months ago (to estimate potential openings available)
skunkworks , Would you have an E-mail address for contacting them ?
The cheapest round trip flight to RST is $250 for me... that doesn't include the hotel room. And one has to go there three times as far as I understand. That would make this cost me $750+... It's cheaper to buy it for $500. Maybe if I can get a prescription for it, I can use my HSA funds to pay for it and that would be pre-tax money. But I've just started traction with the ESL40, I guess I can wait for feedback on the restorex from other forum users before I spend that kind of money.
Hey pey ron,
Just an FYI: All plans are different, but wanted to let you know that I was able to get mine though my work FSA. It was initially denied but then I got a letter from my urologist stating that I had Peyronies Disease and that it was a medical necessity and it was approved.
Hi, there.. I am new here , I arrive a bit late :-( how could i get contact info for further details?
Thanks