NCT05244486 Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
| NCT ID | NCT05244486 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Charitable Union for the Research and Education of Peyronie's Disease |
| Condition | Erectile Dysfunction Following Radical Prostatectomy |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-03-12 |
| Primary Completion | 2028-09-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2022-03-12 with a primary completion date of 2028-09-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Undergoing bilateral nerve-sparing prostatectomy * \>18 years old * Have a regular sexual partner for at least 6 months prior to study enrollment Exclusion Criteria: * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05244486 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Erectile Dysfunction Following Radical Prostatectomy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05244486 currently recruiting?
Yes, NCT05244486 is actively recruiting participants. Contact the research team at landontrost@gmail.com for enrollment information.
Where is the NCT05244486 trial being conducted?
This trial is being conducted at Phoenix, United States, Chicago, United States, Newark, United States, Orem, United States.
Who is sponsoring the NCT05244486 clinical trial?
NCT05244486 is sponsored by Charitable Union for the Research and Education of Peyronie's Disease. The trial plans to enroll 200 participants.