Penile Lengthening Pre-Penile Prosthesis Implantation
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|ClinicalTrials.gov Identifier: NCT03500406|
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : January 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction||Device: RestoreX Other: Control||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Penile Lengthening Pre-Penile Prosthesis Implantation|
|Actual Study Start Date :||March 23, 2018|
|Estimated Primary Completion Date :||March 23, 2021|
|Estimated Study Completion Date :||March 23, 2021|
Sham Comparator: Group 1 - Control
No treatment will be administered and men will not have to delay their IPP procedure
Experimental: Group 2 - PTT 3x daily x 3 months
Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP
Penile traction therapy in the straight position
- Length Assessment of Penile Prosthesis Implanted [ Time Frame: From baseline to 3 months ]The primary objective is to assess the length of the penile prosthesis inserted into subjects following completion of RestoreX® traction therapy compared to the control group (no treatment)
- Participant Compliance [ Time Frame: From baseline to 3 months ]Compare Participant compliance with traction device
- Participant Satisfaction with Traction [ Time Frame: From baseline to 3 months ]Compare patient reported satisfaction with use of traction device
- Adverse Events with use of Traction [ Time Frame: From baseline to 3 months ]Evaluate any adverse events with use of RestoreX® for penile lengthening.
- Operative Complications [ Time Frame: 3, 6, 12 months post-operative ]Compare intra- and/or post-operative complication rates.
- Stretched Penile Length [ Time Frame: From baseline to 12 months ]Compare pre- and post-operative stretched penile lengths
- Participant Satisfaction Penile Length [ Time Frame: Baseline to 12 months post-operative ]Compare participant satisfaction scores including satisfaction with overall penile length
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03500406
|United States, Minnesota|
|Mayo Clinic in Rochester||Recruiting|
|Rochester, Minnesota, United States, 55905|
|Contact: Brett Milazzo 507-538-6151 email@example.com|
|United States, Missouri|
|Washington University School of Medicine||Not yet recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Yifen Meng 314-574-7366 firstname.lastname@example.org|
|Principal Investigator:||Landon W Trost||Mayo Clinic|