Recruiting

RestoreX

Sponsor:

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

Code:

NCT05244486

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RestoreX 1-6 months (randomized phase)

RestoreX 6-9 months (open label phase)

Study Details

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.

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Study ID

NCT05244486

Start date

Mar 12, 2022

Status verified date

Aug, 2026

Completion date

Sep 14, 2030

Anticipated

Primary completion date

Sep 14, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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.

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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Landon Trost, MD

801-655-0015landontrost@gmail.com

Locations

Mayo Clinic Arizona

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Research Coordinator

480-574-1782

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Sophia Kallas, BA

312-694-0633sophia.kallas@northwestern.edu

Nikki Hubbard, BA

312-694-0611nikki.hubbard@northwestern.edu

University Hospital

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Evan Kovac, MD

973-972-7162ek752@njms.rutgers.edu

Saharsh Patel, MS

973-561-7047ssp186@gsbs.rutgers.edu

The Male Fertility and Peyronie's Clinic

Recruiting

Orem, Utah, United States, 84057

Contacts

Landon Trost, MD

(888) 655-0015trost.landon@mfp.clinic

More Information

Sponsor

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

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • Penile traction therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Charitable Union for the Research and Education of Peyronie's Disease on 2026-08-26. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.