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

Part of paid clinical trials in Orem, Utah.

Sponsor
Charitable Union for the Research and Education of Peyronie's Disease
Study ID
NCT05244486
Status
Recruiting
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Conditions

  • Erectile Dysfunction Following Radical Prostatectomy

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RestoreX 1-6 months (randomized phase) — DEVICE
    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.
  • RestoreX 6-9 months (open label phase) — DEVICE
    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).

Study Details

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 Dates

Start date
Mar 12, 2022
Status verified
Feb 2025
Primary completion
Sep 14, 2028
Completion
Sep 14, 2030

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Treatment Arm
    Men will begin utilizing PTT 30-60 minutes daily for 5-7 days weekly beginning 1 month post-prostatectomy until 6 months. After 6 months, they will have the option to continue to use the therapy for 3 additional months or discontinue at their discretion.
  • Active Comparator: Control
    Men will not utilize PTT for the first 6 months post-prostatectomy. Beginning at 6 months, they may utilize PTT if they desire (open label) until 9 months post-prostatectomy.

Primary Outcome Measure

Erectile Function Post-Prostatectomy [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Male Fertility and Peyronie's ClinicOremUtah84057
Landon Trost, MD
[email protected]
888-655-0015
Benjamin D. Green, Economics/MA (SUB_INVESTIGATOR)
Holli Burgon (SUB_INVESTIGATOR)

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By research site
The Male Fertility and Peyronie's Clinic· Orem, UT

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