Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
Recruiting now · Not applicable
Conditions studied: Erectile Dysfunction Following Radical Prostatectomy
In brief
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.
Key facts
- Study ID
- NCT05244486
- Run by
- Charitable Union for the Research and Education of Peyronie's Disease
- People needed
- 200
- Starts
- 2022-03-12
- Expected to finish
- 2030-09-14
- Last updated by the study team
- 2025-02-13
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Undergoing bilateral nerve-sparing prostatectomy
- >18 years old
- Have a regular sexual partner for at least 6 months prior to study enrollment
You may not qualify if…
- 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
Where it is running
- The Male Fertility and Peyronie's Clinic — Orem, Utah, United States (enrolling)
Full record on ClinicalTrials.gov
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