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.

Study Overview

• Status: Terminated
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Other: Control; Device: RestoreX

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria

• Men undergoing placement of a penile prosthesis
• Must be the first time a penile prosthesis is implanted
• Undergoing implantation of a 3-piece inflatable penile prosthesis

Exclusion Criteria

• Prior ischemic priapism
• Any prior penile prosthesis surgeries
• Any prior penile surgeries other than circumcision
• Undergoing malleable penile prosthesis or Ambicor device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Group 1 - Control; No treatment will be administered and men will not have to delay their IPP procedure	Other: Control; No treatment
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	Device: RestoreX; Penile traction therapy in the straight position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length Assessment of Penile Prosthesis Implanted	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)	From baseline to 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Landon W Trost, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2018
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 9, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

• Last Update Posted (Actual): January 6, 2020
• Last Update Submitted That Met QC Criteria: January 3, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: 17-011052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes