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Penile Traction Device

RestoreX Therapy for Erectile Dysfunction Post-Prostatectomy

N/A
Recruiting
Research Sponsored by Charitable Union for the Research and Education of Peyronie's Disease
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
>18 years old
Undergoing bilateral nerve-sparing prostatectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights

Study Summary

This trial will compare men who use the RestoreX device to preserve erectile function after prostatectomy to those who don't. The primary outcome will be changes in the IIEF-EFD scores between groups at 6 months.

Who is the study for?
Men over 18 with preserved erectile function facing prostatectomy can join this trial. They must be undergoing nerve-sparing surgery, not need post-op radiation or hormone therapy, and have had a stable sexual partner for the past 6 months. Men with severe ED or urethral complications from surgery are excluded.Check my eligibility
What is being tested?
The RestoreX penile traction device's effectiveness in maintaining erectile function after robotic-assisted prostatectomy is being tested. Participants will use the device for up to 9 months, with their erectile function scored at intervals to measure any changes.See study design
What are the potential side effects?
While specific side effects aren't listed here, penile traction devices may cause discomfort, bruising, or skin irritation. More serious side effects could include decreased sensation or injury to the penis if used improperly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 years old.
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I am having surgery to remove my prostate while preserving nerve function.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Erectile Function Post-Prostatectomy
Secondary outcome measures
Adverse events at 3 months
Adverse events at 6 months
Adverse events at 9 months
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment ArmExperimental Treatment2 Interventions
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.
Group II: ControlActive Control1 Intervention
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.

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Who is running the clinical trial?

Charitable Union for the Research and Education of Peyronie's DiseaseLead Sponsor
3 Previous Clinical Trials
180 Total Patients Enrolled

Media Library

RestoreX (Penile Traction Device) Clinical Trial Eligibility Overview. Trial Name: NCT05244486 — N/A
Erectile Dysfunction Research Study Groups: Treatment Arm, Control
Erectile Dysfunction Clinical Trial 2023: RestoreX Highlights & Side Effects. Trial Name: NCT05244486 — N/A
RestoreX (Penile Traction Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05244486 — N/A
Erectile Dysfunction Patient Testimony for trial: Trial Name: NCT05244486 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies within the study for prospective participants?

"Affirmative. Perusing clinicaltrials.gov reveals that the recruitment of candidates for this experiment began on March 12th 2022 and is still ongoing. 200 individuals must be sourced from a single site in order to reach completion."

Answered by AI

What is the current sample size of this experiment?

"Affirmative. There is information on clinicaltrials.gov that confirms this medical trial, first published on March 12th 2022, is actively enrolling patients. A total of 200 individuals are being wanted from a single site for the study's recruitment process."

Answered by AI

Who else is applying?

What state do they live in?
New York
Mississippi
Pennsylvania
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
1

Why did patients apply to this trial?

I’m hoping to naturally gain length to increase frequency of *** with partner.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy
Landon Trost 2022. "Efficacy of RestoreX Penile Traction Therapy In Preserving Erectile Function Post-Prostatectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05244486.
All > Erectile Dysfunction
~27 spots leftby Sep 2024
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