Penile Length Restoration in Men With Diabetes Mellitus, Type II

Mayo Clinic

Status: Completed

Conditions: Penile Diseases; Diabetes Mellitus, Type 2

Treatments: Device: RestoreX PTT - 6 months; Device: RestoreX PTT - 3 months

Study type: Interventional

Funder types: Other

Identifiers

NCT03756688

18-006696

Details and patient eligibility

About

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.

Full 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.

Enrollment: 110 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men with Diabetes Mellitus, Type II

Exclusion criteria

• Any evidence of end-organ failure attributed to DM (assessed based on medical history / patient history alone)
• Loss of fingers / toes.
• CKD Stage IV or greater.
• Retinopathy
• Myocardial infarction.
• Cerebrovascular accident.
• Indwelling penile prosthesis or prior history of penile prosthesis.
• Peyronie's disease at baseline.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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110 participants in 4 patient groups

Group 1: Control

No Intervention group

Description:

No treatment will be administered for the entirety of the study (6 months)

Group 2: Treatment

Experimental group

Description:

PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months

Treatment:

Device: RestoreX PTT - 3 months

Group 3: Treatment

Experimental group

Description:

PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months

Treatment:

Device: RestoreX PTT - 6 months

Group 4: Treatment

Experimental group

Description:

PTT for 30 min 2x day x 6 months

Treatment:

Device: RestoreX PTT - 6 months