Penile Lengthening Pre-Penile Prosthesis Implantation

NCT07053826 | Recruiting

• 1 other identifier: STUDY24110037
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to determine whether or not the use of a penile traction therapy device known as RestoreX prior to implantation of a penile prosthesis can increase the length of the implant used during surgery. The device used in this study is commercially available and has been used successfully to facilitate penile lengthening in patients with diabetes and after a certain type of prostate surgery. Use of the device has not been shown to have any detrimental effects on sexual or overall health.

Conditions

Erectile Dysfunction

Keywords

Erectile Dysfunction; Inflatable Penile Prosthesis; Penile Traction Therapy; RestoreX; Penile Enlargement

Outcome Measures

Primary Outcomes (4)

• Penile Length

  Change in stretched penile length measured at time of enrollment and intraoperatively at the time of IPP implantation, measured in cm.

  At screening to approximately three months after enrollment at the time of penile prosthesis implantation

• Prosthesis size

  Size of inflatable penile prosthesis cylinders placed

  0-4 months after enrollment at the time of penile prosthesis implantation

• Sexual Satisfaction

  Change in patient-reported satisfaction with their sexual function from enrollment to final postoperative follow up using the validated IIEF-15 (International Index of Erectile function - 15 item) questionnaire, which has a minimum score of 6 and maximum score of 75 with a larger number indicating improved sexual satisfaction. The change seen in participants assigned to the RestoreX device arm will be compared to the change seen in patients assigned to the control arm.

  At enrollment and at three-month postoperative follow up.

• Incidence of Satisfaction with Penile Length

  A comparison of the incidence of participants reporting satisfaction with their penile length, expressed as a percentage or all participants within each group, based on participant reporting to an investigator during their surgical follow up.

  3-8 months postoperatively

Secondary Outcomes (4)

• Compliance with Therapy

  0-4 months after enrollment, intervention arm only

• Incidence of adverse events

  0-16 months

• Patient Satisfaction with Prosthesis Use

  3-7 months

• Patient Satisfaction with Prosthesis Use

  3-8 months

Study Arms (2)

Penile Prosthesis Implantation

ACTIVE COMPARATOR

Patients with erectile dysfunction presenting for placement of a three-piece inflatable prosthesis who are randomized to the no intervention arm will proceed directly to implantation of a standard-of-care inflatable penile prosthesis at the next available surgical appointment. They will not use the RestoreX penile traction device. They will complete standardized assessments of sexual function and satisfaction before and after placement.

Procedure: Inflatable Penile Prosthesis Implantation

RestoreX and Penile Prosthesis Implantation

EXPERIMENTAL

Patients with erectile dysfunction presenting for placement of a three-piece inflatable prosthesis who are randomized to the intervention arm will be provided with a RestoreX penile traction device, which they will utilize for three months prior to implantation of a standard-of-care inflatable penile prosthesis. They will complete standardized assessments of sexual function and satisfaction before and after placement, as well as a device use diary.

Device: Penile Traction Device; Procedure: Inflatable Penile Prosthesis Implantation

Interventions

Penile Traction Device DEVICE

Patients will be randomized into one of two groups: penile traction therapy 30 min 3x/day x 3 months, or control (no treatment). Preoperative erectile function surveys will be recorded in the EMR per standard of care. Following randomization, patients allocated to the treatment arm will be instructed how to use the device properly. Patients in the treatment arm will record a daily journal of use of the device (Appendix 1). After a minimum of 3 months, patients in the treatment arm will return for their scheduled procedure. Control arm patients will be scheduled directly for an OR date.

Also known as: RestoreX, PTT

RestoreX and Penile Prosthesis Implantation

Inflatable Penile Prosthesis Implantation PROCEDURE

Implantation of a three-component inflatable penile prosthesis.

Penile Prosthesis Implantation; RestoreX and Penile Prosthesis Implantation

Eligibility Criteria

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

You may qualify if:

• Have a documented diagnosis of erectile dysfunction
• Can provide informed consent
• Are willing and able to comply with study procedures and visit schedules
• Are to be scheduled for a planned standard of care implantation of an inflatable penile prosthesis

You may not qualify if:

• Prior ischemic priapism
• Prior implantation of a penile prosthesis
• Prior use of any penile traction device
• Any prior penile surgeries other than circumcision
• Prior pelvic radiation
• Current or prior androgen deprivation therapy
• Active genital infection
• History of neophallus creation

Sponsors & Collaborators

• University of Pittsburgh: lead
• Pathright Medical: collaborator

Study Sites (1)

UPMC Mercy Hospital, Urology

Pittsburgh, Pennsylvania, 15219, United States

RECRUITING

Related Publications (5)

• Ziegelmann M, Savage J, Toussi A, Alom M, Yang D, Kohler T, Trost L. Outcomes of a Novel Penile Traction Device in Men with Peyronie's Disease: A Randomized, Single-Blind, Controlled Trial. J Urol. 2019 Sep;202(3):599-610. doi: 10.1097/JU.0000000000000245. Epub 2019 Aug 8.

  PMID: 30916626 BACKGROUND

• 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 BACKGROUND

• Toussi A, Ziegelmann M, Yang D, Manka M, Frank I, Boorjian SA, Tollefson M, Kohler T, Trost L. Efficacy of a Novel Penile Traction Device in Improving Penile Length and Erectile Function Post Prostatectomy: Results from a Single-Center Randomized, Controlled Trial. J Urol. 2021 Aug;206(2):416-426. doi: 10.1097/JU.0000000000001792. Epub 2021 Jun 1.

  PMID: 34060339 BACKGROUND

• Trost LW, Munarriz R, Wang R, Morey A, Levine L. External Mechanical Devices and Vascular Surgery for Erectile Dysfunction. J Sex Med. 2016 Nov;13(11):1579-1617. doi: 10.1016/j.jsxm.2016.09.008.

  PMID: 27770853 BACKGROUND

• Levine LA, Rybak J. Traction therapy for men with shortened penis prior to penile prosthesis implantation: a pilot study. J Sex Med. 2011 Jul;8(7):2112-7. doi: 10.1111/j.1743-6109.2011.02285.x. Epub 2011 Apr 14.

  PMID: 21492409 BACKGROUND

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• J. Peter Rubin, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roger D Klein, MD, PhD

CONTACT

800-533-8762; urologyresearch@upmc.edu

Michelle Lucas, MS

CONTACT

412-624-4708; mcmeansmm2@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Endowed Chair of Plastic Surgery

Model Details: This is a double-armed, controlled, open-label randomized trial assessing the above outcomes in the presence or absence of preoperative penile traction device (RestoreX) use.

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: August 26, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)