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Completed

NCT Number: NCT03756688

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Genital Diseases Genital Diseases, Male Glucose Metabolism Disorders Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Penile Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RestoreX PTT - 6 months

Device

Penile traction therapy in straight position for all 6 months.

RestoreX PTT - 3 months

Device

Penile traction therapy in straight position for first phase (3 months)

Primary outcomes

  1. Penile Length Change Between Baseline and Month 6

    Time frame: 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 outcomes

  1. Patient Compliance With Traction Therapy

    Time frame: 6 months

    Records of use from daily journals

  2. Patient Reported Satisfaction With Traction Therapy at 6 Months.

    Time frame: 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.

  3. Number of Participants With Adverse Events With Use of RestoreX

    Time frame: 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.

  4. Number of Participants With De-novo Peyronie's Disease Development

    Time frame: 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

  5. Subjective Comparison of Changes in Penile Length

    Time frame: 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.

  6. Erectile Function Among Groups - Evaluating Change From Baseline to 6 Months.

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 28, 2018
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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