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

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.

Conditions

Erectile Dysfunction Following Radical Prostatectomy

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Erectile Dysfunction Following Radical Prostatectomy
Intervention / Treatment

-

Contacts and Locations

Orem

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Undergoing bilateral nerve-sparing prostatectomy
  • * \>18 years old
  • * Have a regular sexual partner for at least 6 months prior to study enrollment
  • * Requiring adjuvant radiation therapy or androgen deprivation / androgen blockade post-operatively (by the time of enrollment)
  • * Baseline severe erectile dysfunction as measured by the IIEF-EFD
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

Study Record Dates

2025-09-14