Penile Lengthening Pre-Penile Prosthesis Implantation

Not Applicable

Terminated

Conditions: Erectile Dysfunction

Interventions: Other: Control
Device: RestoreX

Registration Number: NCT03500406

Lead Sponsor: Mayo Clinic

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Male

Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 - Control	Control	No treatment will be administered and men will not have to delay their IPP procedure
Group 2 - PTT 3x daily x 3 months	RestoreX	Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP

Primary Outcome Measures

Name	Time	Method
Length Assessment of Penile Prosthesis Implanted	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)

Secondary Outcome Measures

Name	Time	Method
Participant Compliance	From baseline to 3 months	Compare Participant compliance with traction device
Participant Satisfaction With Traction	From baseline to 3 months	Compare patient reported satisfaction with use of traction device
Adverse Events With Use of Traction	From baseline to 3 months	Evaluate any adverse events with use of RestoreX® for penile lengthening.
Operative Complications	3, 6, 12 months post-operative	Compare intra- and/or post-operative complication rates.
Stretched Penile Length	From baseline to 12 months	Compare pre- and post-operative stretched penile lengths
Participant Satisfaction Penile Length	Baseline to 12 months post-operative	Compare participant satisfaction scores including satisfaction with overall penile length

Trial Locations

Locations (2): Mayo Clinic in Rochester
🇺🇸
Rochester, Minnesota, United States
Washington University School of Medicine
🇺🇸
Saint Louis, Missouri, United States