Penile Length Restoration in Men With Diabetes Mellitus, Type II

Not Applicable

Completed

Conditions: Penile Diseases
Diabetes Mellitus, Type 2

Interventions: Device: RestoreX PTT - 3 months
Device: RestoreX PTT - 6 months

Registration Number: NCT03756688

Lead Sponsor: Mayo Clinic

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 110

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Group 2: Treatment	RestoreX PTT - 3 months	PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months
Group 4: Treatment	RestoreX PTT - 6 months	PTT for 30 min 2x day x 6 months
Group 3: Treatment	RestoreX PTT - 6 months	PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months

Primary Outcome Measures

Name	Time	Method
Penile Length Change Between Baseline and Month 6	Baseline to 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Patient Compliance With Traction Therapy	6 months	Records of use from daily journals
Patient Reported Satisfaction With Traction Therapy at 6 Months.	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.
Number of Participants With Adverse Events With Use of RestoreX	3 and 6 months post-prostatectomy	Adverse events were assessed at 3- and 6-months post-prostatectomy, with results summed and reported as a total.
Number of Participants With De-novo Peyronie's Disease Development	6 months	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
Subjective Comparison of Changes in Penile Length	6 months	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.
Erectile Function Among Groups - Evaluating Change From Baseline to 6 Months.	Baseline and 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)