Penile Length Restoration in Men With Diabetes Mellitus, Type II

Study Overview
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Brief Summary
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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
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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.

Official Title
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Penile Length Restoration in Men With Diabetes Mellitus, Type II

Conditions
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Diabetes Mellitus, Type 2, Penile Diseases

Intervention / Treatment
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* Device: RestoreX PTT - 6 months
* Device: RestoreX PTT - 3 months


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Patients will be randomized into one of four groups: Penile Traction Therapy (PTT) for 30 min 2x/day x 3 months, followed by no treatment x 3 months PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months PTT for 30 min 2x/day x 6 months Control (no treatment)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group 1: Control<br>No treatment will be administered for the entirety of the study (6 months) | |
| Experimental: Group 2: Treatment<br>PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months | Device: RestoreX PTT - 3 months<br>* Penile traction therapy in straight position for first phase (3 months)<br>|
| Experimental: Group 3: Treatment<br>PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months | Device: RestoreX PTT - 6 months<br>* Penile traction therapy in straight position for all 6 months.<br>|
| Experimental: Group 4: Treatment<br>PTT for 30 min 2x day x 6 months | Device: RestoreX PTT - 6 months<br>* Penile traction therapy in straight position for all 6 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penile Length Change Between Baseline and Month 6 | Primary objective of this study is to assess penile length pre and post completion of RestoreX traction therapy compared to control groups (no treatment) of Diabetes Type II patients. Measurements were obtained at baseline and 6 months post-prostatectomy. | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Compliance With Traction Therapy | Records of use from daily journals | 6 months | 
| Patient Reported Satisfaction With Traction Therapy at 6 Months. | Likert scale used to assess self-reported overall satisfaction; 1-10 (10 = maximum satisfaction); higher values signify a better outcome. Satisfaction was assessed at 6 months post-prostatectomy. | 6 months | 
| Number of Participants With Adverse Events With Use of RestoreX | Adverse events were assessed at 3- and 6-months post-prostatectomy, with results summed and reported as a total. | 3 and 6 months post-prostatectomy | 
| Number of Participants With De-novo Peyronie's Disease Development | Subjective question to determine if the patient has developed any new penile curvature, indentation, deformity, or other findings consistent with Peyronie's Disease during the study period | 6 months | 
| Subjective Comparison of Changes in Penile Length | Subjective questions on patient perceived improvement in length (yes/no, qualitative [large, medium, small, none]); note that some groups add to >100% due to the effects of rounding. | 6 months | 
| Erectile Function Among Groups - Evaluating Change From Baseline to 6 Months. | Standardized questionnaire assessment of erectile function (International Index of Erectile Function standardized questionnaire, Erectile Function Domain [questions 1-5 and 15]). Higher scores are better. Assessments were obtained at baseline and at 6 months post-prostatectomy with the result reported being 6 months minus baseline. Minimum score for the change since baseline = -29 (i.e. 1 minus 30), maximum score = 29 (i.e. 30 minus 1) | Baseline and 6 months |