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NCT05244486 · ClinicalTrials.gov registry record · NA
Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
A NA study of Erectile Dysfunction Following Radical Prostatectomy, sponsored by Charitable Union for the Research and Education of Peyronie's Disease.
- Recruiting
- Registry status
- NA
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT05244486: Recruiting NA study of Erectile Dysfunction Following Radical Prostatectomy, sponsored by Charitable Union for the Research and Education of Peyronie's Disease.
NCT05244486 is a NA study of Erectile Dysfunction Following Radical Prostatectomy that is actively recruiting participants, run by Charitable Union for the Research and Education of Peyronie's Disease. The registered enrollment target is 200 participants, above the 166-participant average among 4 other Erectile Dysfunction Following Radical Prostatectomy trials with a reported enrollment target (20% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05244486, a NA study of Erectile Dysfunction Following Radical Prostatectomy, is actively recruiting participants, sponsored by Charitable Union for the Research and Education of Peyronie's Disease.
- RECRUITING
- Registry status
- NA
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Compare erectile function between treatment and control cohorts, as assessed by the International Index of Erectile Function, Erectile Function Domain (IIEF-EFD) at 6-months post-prostatectomy. IIEF-EFD scores 1-30, with higher scores representing better function.
Conditions Studied
Interventions
- DEVICE RestoreX 1-6 months (randomized phase)
- DEVICE RestoreX 6-9 months (open label phase)
Study Locations (1)
Utah
- The Male Fertility and Peyronie's Clinic - Orem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2022-03-12 |
| Est. Completion | 2030-09-14 |
| Phase | NA |
What NCT05244486 shows while recruiting
NCT05244486 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 166-participant average among 4 other Erectile Dysfunction Following Radical Prostatectomy trials with a reported enrollment target (20% higher).
The record links to 1 condition, with Erectile Dysfunction Following Radical Prostatectomy appearing as the primary indexed condition, and to 2 interventions - of which RestoreX 1-6 months (randomized phase) is the first listed.
NCT05244486 reports a single indexed study location in Utah.
Frequently Asked Questions
What is clinical trial NCT05244486 about?
NCT05244486 is a clinical study titled "Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy". 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...
What is the current status of trial NCT05244486?
This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2022-03-12. Estimated completion is 2030-09-14.
What conditions does trial NCT05244486 study?
This clinical trial studies the following conditions: Erectile Dysfunction Following Radical Prostatectomy.
What interventions are being tested in trial NCT05244486?
The interventions under investigation include: RestoreX 1-6 months (randomized phase) (DEVICE), RestoreX 6-9 months (open label phase) (DEVICE).
Who is sponsoring clinical trial NCT05244486?
This trial is sponsored by Charitable Union for the Research and Education of Peyronie's Disease, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05244486 being conducted?
This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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