RECRUITING

Penile Lengthening Pre-Penile Prosthesis Implantation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to determine whether or not the use of a penile traction therapy device known as RestoreX prior to implantation of a penile prosthesis can increase the length of the implant used during surgery. The device used in this study is commercially available and has been used successfully to facilitate penile lengthening in patients with diabetes and after a certain type of prostate surgery. Use of the device has not been shown to have any detrimental effects on sexual or overall health.

Official Title

Prospective, Randomized, Controlled Trial to Evaluate the Effect of Preoperative Penile Traction Therapy on Post-penile Implant Length and Patient Satisfaction

Quick Facts

Study Start:2025-08-26
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07053826

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have a documented diagnosis of erectile dysfunction
  2. * Can provide informed consent
  3. * Are willing and able to comply with study procedures and visit schedules
  4. * Are to be scheduled for a planned standard of care implantation of an inflatable penile prosthesis
  1. * Prior ischemic priapism
  2. * Prior implantation of a penile prosthesis
  3. * Prior use of any penile traction device
  4. * Any prior penile surgeries other than circumcision
  5. * Prior pelvic radiation
  6. * Current or prior androgen deprivation therapy
  7. * Active genital infection
  8. * History of neophallus creation

Contacts and Locations

Study Contact

Roger D Klein, MD, PhD
CONTACT
800-533-8762
urologyresearch@upmc.edu
Michelle Lucas, MS
CONTACT
412-624-4708
mcmeansmm2@upmc.edu

Principal Investigator

J. Peter Rubin, MD
PRINCIPAL_INVESTIGATOR
University of Pittsburgh

Study Locations (Sites)

UPMC Mercy Hospital, Urology
Pittsburgh, Pennsylvania, 15219
United States

Collaborators and Investigators

Sponsor: University of Pittsburgh

  • J. Peter Rubin, MD, PRINCIPAL_INVESTIGATOR, University of Pittsburgh

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-26
Study Completion Date2027-02

Study Record Updates

Study Start Date2025-08-26
Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

  • Erectile Dysfunction
  • Inflatable Penile Prosthesis
  • Penile Traction Therapy
  • RestoreX
  • Penile Enlargement

Additional Relevant MeSH Terms

  • Erectile Dysfunction