Erectile Dysfunction Clinical Trial
Official title:
Penile Lengthening Pre-Penile Prosthesis Implantation
This study is intended to utilize a novel, class I (ie. lowest risk, clinical studies not required) medical device to determine whether penile length can be increased in men prior to undergoing a penile prosthesis implantation procedure.
Men with erectile dysfunction, unresponsive to conservative therapies, are recommended to
undergo placement of an inflatable penile prosthesis (IPP); however, it is a common complaint
post-operatively that their penis length is shorter than what it was previously.
Several attempts have been made by investigators to optimize penile length prior to placement
of the penile prosthesis. Compared to other options, penile traction therapy (PTT) offers
several potential advantages in that it is minimally-invasive, does not increase the
morbidity of surgery, and has not been shown to result in any long-term side effects.
A new penile traction device (RestoreX® ) was created and funded through Mayo Ventures. Given
the clinical issue of dissatisfaction with penile length post IPP, the potential role for
PTT, and limited amount of data available, we sought to perform a clinical trial evaluating
the effect of PTT on increasing the total length of prosthesis which can be inserted. We
additionally sought to determine if PTT resulted in improved post-operative satisfaction on
total penile length achieved.
To accomplish the study, a population of men from Mayo Clinic planning to undergo placement
of an IPP will be enrolled and given the option to either join the control (no treatment)
group or PTT group for 3 months prior to their procedure. Outcomes will be assessed prior to
surgery and 3, 6, and 12 months post-procedure. Results are to be used with the intent to
publish in a scientific journal.
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