Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT03500406
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT03500406
Study Brief:
Protocol Section:
NCT03500406