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Penile Length Restoration in Men With Diabetes Mellitus, Type II

NCT03756688 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2023-02-21

Study results available
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Summary

The objective of the current study is to evaluate the efficacy of a novel penile traction device in restoring lost penile length in men with type 2 diabetes.

Conditions

  • Diabetes Mellitus, Type 2
  • Penile Diseases

Interventions

DEVICE

RestoreX PTT - 6 months

Penile traction therapy in straight position for all 6 months.

DEVICE

RestoreX PTT - 3 months

Penile traction therapy in straight position for first phase (3 months)

Sponsors & Collaborators

Principal Investigators

  • Matthew Ziegelmann, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-07
Primary Completion
2021-03-18
Completion
2021-03-18
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03756688 on ClinicalTrials.gov