Health TrialsbyHealthPanel

Penile Lengthening Pre-Penile Prosthesis Implantation

ConditionErectile Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorJ. Peter Rubin, MD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Prior ischemic priapism

Prior implantation of a penile prosthesis

Prior use of any penile traction device

Any prior penile surgeries other than circumcision

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Inflatable Penile Prosthesis Implantation

    Procedure/Surgery

    Implantation of a three-component inflatable penile prosthesis.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Penile Prosthesis ImplantationActive comparator 1 intervention
Group B: RestoreX and Penile Prosthesis ImplantationExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Penile Length

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

Time frame
At screening to approximately three months after enrollment at the time of penile prosthesis implantation
2

Prosthesis size

Size of inflatable penile prosthesis cylinders placed

Time frame
0-4 months after enrollment at the time of penile prosthesis implantation
3

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.

Time frame
At enrollment and at three-month postoperative follow up.
4

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.

Time frame
3-8 months postoperatively

Secondary outcomes

1

Compliance with Therapy

Patient compliance with traction device regimen using a device use diary will be assessed. Compliance will be reported as a percentage of recommended use sessions completed.

Time frame
0-4 months after enrollment, intervention arm only
2

Incidence of adverse events

The incidence of all adverse events arising from penile traction therapy device use or inflatable penile prosthesis placement will be monitored throughout the study during in-person encounters and via chart review at the conclusion of the study.

Time frame
0-16 months
3

Patient Satisfaction with Prosthesis Use

Patient satisfaction with their penile prosthesis will be assessed postoperatively using the validated Quality of Life and Sexuality after Penile Prosthesis (QoLSPP) survey, a 16-item survey with a maximum score of 80 and minimum score of 0, where a higher score corresponds to increased satisfaction. Scores of patients undergoing prosthesis placement alone will be compared to those of patients undergoing RestoreX therapy prior to prosthesis placement.

Time frame
3-7 months
4

Patient Satisfaction with Prosthesis Use

Patients randomized to RestoreX device use prior to prosthesis placement will be asked if they would use a penile traction device again, and how satisfied they were, on surveys administered immediately prior to, and three months following, prosthesis placement using Likert-style questions.

Time frame
3-8 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

J. Peter Rubin, MD

Lead sponsor

University of Pittsburgh

Sponsor institution

Pathright Medical

Collaborator

Source ClinicalTrials.gov
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