Clinical trial NCT03756688: Penile Length Restoration in Men With Diabetes Mellitus, Type II
Official title: Penile Length Restoration in Men With Diabetes Mellitus, Type II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Penile Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 110
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Patients will be randomized into one of four groups:

1. Penile Traction Therapy (PTT) for 30 min 2x/day x 3 months, followed by no treatment x 3 months
2. PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months
3. PTT for 30 min 2x/day x 6 months
4. Control (no treatment)
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Penile Length Change Between Baseline and Month 6
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Patient Compliance With Traction Therapy
timeFrame: 6 months
measure: Patient Reported Satisfaction With Traction Therapy at 6 Months.
timeFrame: 6 months
measure: Number of Participants With Adverse Events With Use of RestoreX
timeFrame: 3 and 6 months post-prostatectomy
measure: Number of Participants With De-novo Peyronie's Disease Development
timeFrame: 6 months
measure: Subjective Comparison of Changes in Penile Length
timeFrame: 6 months
measure: Erectile Function Among Groups - Evaluating Change From Baseline to 6 Months.
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Matthew Ziegelmann, MD
role: PRINCIPAL_INVESTIGATOR
References: