NCT03756688

Penile Length Restoration in Men With Diabetes Mellitus, Type II

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Men with diabetes mellitus experience sexual dysfunctions at an earlier age and higher rate compared to men without diabetes. One of these sexual dysfunctions includes diminished penile length. It is currently unknown if the decreased length is due to earlier erectile dysfunction or secondary to diabetes itself. Penile traction therapy is one of several treatments which have been used historically to treat decreased penile length, however, to date, no studies have evaluated the role of traction therapy in men with diabetes. To accomplish the study, a population of men from Mayo Clinic with a diagnosis of diabetes, type II will be enrolled and will be randomized to utilize the device for varying amounts of time. Outcomes will be assessed at the 3 and 6 month time points, and the results are to be used with the intent to publish in a scientific journal.

Conditions

• Diabetes Mellitus, Type 2
• Penile Diseases

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2018-11-07
• Primary completion: 2021-03-18
• Completion: 2021-03-18
• First posted: 2018-11-28
• Last updated: 2023-02-21
• Results posted: 2023-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study