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Penile Traction Device

Penile Length Restoration in Men With Diabetes Mellitus, Type II

N/A
Waitlist Available
Led By Matthew Ziegelmann, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
- Men with Diabetes Mellitus, Type II
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 and 6 months post-prostatectomy
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new device that gently stretches the penis to help men with type 2 diabetes regain lost penile length. Men with diabetes often have shorter penises due to their condition or related erectile issues. The device works by applying a gentle stretch over time, and the study will measure results after several months.

Eligible Conditions
  • Erectile Dysfunction
  • Diabetes
  • Type 2 Diabetes
  • Penile Diseases

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 and 6 months post-prostatectomy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 and 6 months post-prostatectomy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Penile Length Change Between Baseline and Month 6
Secondary study objectives
Erectile Function Among Groups - Evaluating Change From Baseline to 6 Months.
Number of Participants With Adverse Events With Use of RestoreX
Number of Participants With De-novo Peyronie's Disease Development
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Group 4: TreatmentExperimental Treatment1 Intervention
PTT for 30 min 2x day x 6 months
Group II: Group 3: TreatmentExperimental Treatment1 Intervention
PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months
Group III: Group 2: TreatmentExperimental Treatment1 Intervention
PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months
Group IV: Group 1: ControlActive Control1 Intervention
No treatment will be administered for the entirety of the study (6 months)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RestoreX PTT - 3 months
2018
N/A
~110
RestoreX PTT - 6 months
2018
N/A
~110

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,351 Previous Clinical Trials
3,060,847 Total Patients Enrolled
7 Trials studying Erectile Dysfunction
124 Patients Enrolled for Erectile Dysfunction
Matthew Ziegelmann, MDPrincipal InvestigatorMayo Clinic
2 Previous Clinical Trials
92 Total Patients Enrolled
1 Trials studying Erectile Dysfunction
10 Patients Enrolled for Erectile Dysfunction
~16 spots leftby Dec 2025
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