Penile Lengthening Pre-Penile Prosthesis Implantation

NCT03500406 | Terminated Results FDA Device

• 1 other identifier: 17-011052
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Participant Compliance

  From baseline to 3 months

• Participant Satisfaction With Traction

  From baseline to 3 months

• Adverse Events With Use of Traction

  From baseline to 3 months

• Operative Complications

  3, 6, 12 months post-operative

• Stretched Penile Length

  From baseline to 12 months

Study Arms (2)

Group 1 - Control

SHAM COMPARATOR

No treatment will be administered and men will not have to delay their IPP procedure

Other: Control

Group 2 - PTT 3x daily x 3 months

EXPERIMENTAL

Men will utilize penile traction therapy for 30 minutes three times daily for the 3 months prior to placement of their IPP

Device: RestoreX

Interventions

RestoreX DEVICE

Penile traction therapy in the straight position

Group 2 - PTT 3x daily x 3 months

Control OTHER

No treatment

Group 1 - Control

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Limitations and Caveats

Study was terminated due to PI change of subspecialties and no longer able to access the main study population. Sincere efforts were made but we were unable to collect data.

Results Point of Contact

• Title: Dr. Landon Trost
• Organization: Mayo Clinic

Trost.Landon@mayo.edu

507-284-3728

Study Officials

• Landon W Trost

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 18, 2018
• Study Start: March 23, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: January 6, 2020
• Results First Posted: January 6, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)