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

NCT05244486 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-02-13

No results posted yet for this study

Summary

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

Interventions

DEVICE

RestoreX 1-6 months (randomized phase)

Study participants are recommended utilize the device for 30-60 minutes, 5-7 days a week starting at 1 month post-prostatectomy and continuing until 6 months.

DEVICE

RestoreX 6-9 months (open label phase)

Both the treatment and control arms will be allowed to use the therapy from 6-9 months post-prostatectomy (open label phase). Only straight traction will be used (no counterbending).

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-12
Primary Completion
2028-09-14
Completion
2030-09-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05244486 on ClinicalTrials.gov