RECRUITING

Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy

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

Evaluate the efficacy of the RestoreX penile traction device in preserving erectile function in men undergoing robotic-assisted prostatectomy. This study will evaluate men undergoing prostatectomy with bilateral nerve preservation and preserved baseline erectile function (moderate ED or better). The primary outcome will be changes in the IIEF-EFD scores between groups at 6 months. Secondary outcomes include differences in questionnaire outcomes at 3, 6, and 9 months.

Official Title

Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy

Quick Facts

Study Start:2022-03-12
Study Completion:2025-09-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05244486

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. * Undergoing bilateral nerve-sparing prostatectomy
  2. * \>18 years old
  3. * Have a regular sexual partner for at least 6 months prior to study enrollment
  1. * Requiring adjuvant radiation therapy or androgen deprivation / androgen blockade post-operatively (by the time of enrollment)
  2. * Baseline severe erectile dysfunction as measured by the IIEF-EFD
  3. * Urethral complications from prostatectomy at the time of baseline visit including contrast extravasation, anastomotic dehiscence of vesicourethral anastomosis, need for re-doing of vesicourethral anastomosis intra-operatively

Contacts and Locations

Study Contact

Landon Trost, MD
CONTACT
801-655-0015
landontrost@gmail.com
Benjamin Green, BA
CONTACT
801-655-0015
bengreen927@gmail.com

Study Locations (Sites)

The Male Fertility and Peyronie's Clinic
Orem, Utah, 84057
United States

Collaborators and Investigators

Sponsor: Charitable Union for the Research and Education of Peyronie's Disease

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 Date2022-03-12
Study Completion Date2025-09-14

Study Record Updates

Study Start Date2022-03-12
Study Completion Date2025-09-14

Terms related to this study

Keywords Provided by Researchers

  • Penile traction therapy

Additional Relevant MeSH Terms

  • Erectile Dysfunction Following Radical Prostatectomy