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

NCT05244486 | Recruiting FDA Device

• 1 other identifier: CUREPD 104
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

Penile traction therapy

Outcome Measures

Primary Outcomes (1)

• Erectile Function Post-Prostatectomy

  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.

  6 months

Secondary Outcomes (8)

• Non-erectile function domains of the International Index of Erectile Function

  6 months

• International Index of Erectile Function from baseline to 6 months

  6 months

• Adverse events at 3 months

  3 months

• Adverse events at 6 months

  6 months

• Adverse events at 9 months

  9 months

Study Arms (2)

Treatment Arm

EXPERIMENTAL

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.

Device: RestoreX 1-6 months (randomized phase); Device: RestoreX 6-9 months (open label phase)

Control

ACTIVE COMPARATOR

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.

Device: RestoreX 6-9 months (open label phase)

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.

Treatment Arm

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).

Control; Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

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

Study Sites (1)

The Male Fertility and Peyronie's Clinic

Orem, Utah, 84057, United States

RECRUITING

Related Publications (1)

• Zganjar A, Toussi A, Ziegelmann M, Frank I, Boorjian SA, Tollefson M, Kohler T, Trost L. Efficacy of RestoreX after prostatectomy: open-label phase of a randomized controlled trial. BJU Int. 2023 Aug;132(2):217-226. doi: 10.1111/bju.16033. Epub 2023 May 9.

  PMID: 37088866 DERIVED

Central Study Contacts

Landon Trost, MD

CONTACT

801-655-0015; landontrost@gmail.com

Benjamin Green, BA

CONTACT

801-655-0015; bengreen927@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Given the nature of the study, it is not possible to mask either the study participant or investigator.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Once enrolled, patients will be randomized 2:1 to receive either Restorex or control (no treatment) beginning at 1 month post-op until 6 months. They will then enter an open label phase for 3 additional months.

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 17, 2022
• Study Start: March 12, 2022
• Primary Completion (Estimated): September 14, 2028
• Study Completion (Estimated): September 14, 2030
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The data will be available for 1 year after the study is completed.
• Access Criteria: Invited centers which have enrolled patients will have access to the de-identified data if desired.

Locations

US (1)