Penile Length Restoration in Men With Diabetes Mellitus, Type II

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Penile Diseases
• Intervention / Treatment: Device: RestoreX PTT - 3 months; Device: RestoreX PTT - 6 months

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alex R Ferguson; Phone Number: 507-422-5102; Email: Ferguson.Alex@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Matthew Ziegelmann, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2018
• Primary Completion (Actual): March 18, 2021
• Study Completion (Actual): March 18, 2021

Study Registration Dates

• First Submitted: November 24, 2018
• First Submitted That Met QC Criteria: November 26, 2018
• First Posted (Actual): November 28, 2018

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Penile Diseases
• Other Study ID Numbers: 18-006696

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No