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Penile Length Restoration in Men With Diabetes Mellitus, Type II

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ClinicalTrials.gov Identifier: NCT03756688
Recruitment Status : Recruiting
First Posted : November 28, 2018
Last Update Posted : November 30, 2018
Sponsor:
Information provided by (Responsible Party):
Landon W. Trost, Mayo Clinic

Brief Summary:
The objective of the current study is to evaluate the efficacy of a novel penile traction device in restoring penile length loss secondary to diabetes mellitus.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Penile Diseases Device: RestoreX PTT - 6 months Device: RestoreX PTT - 3 months Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
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)
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: The provider and outcome assessor will be blinded to the patient's study arm for all length assessments. Additionally, the assessor will be blinded to prior length measurements.
Primary Purpose: Treatment
Official Title: Penile Length Restoration in Men With Diabetes Mellitus, Type II
Actual Study Start Date : November 7, 2018
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

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.




Primary Outcome Measures :
  1. Penile Length [ 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.


Secondary Outcome Measures :
  1. Patient compliance with traction therapy [ Time Frame: Baseline to 6 months ]
    Records of use from daily journals

  2. Patient reported satisfaction with traction therapy [ Time Frame: Baseline to 6 months ]
    Likert scale used to assess self-reported overall satisfaction; 1-10 (10 = maximum satisfaction); higher values signify a better outcome

  3. Adverse events with use of RestoreX [ Time Frame: Baseline to 6 months ]
    Comprehensive adverse event reporting will be performed at every assessment time point

  4. De-novo Peyronie's Disease development [ Time Frame: Baseline to 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: Baseline to 6 months ]
    Subjective questions on patient perceived improvement in length (yes/no, % estimated, qualitative [large, medium, small, none])

  6. Erectile function among groups [ Time Frame: Baseline to 6 months ]
    Standardized questionnaire assessment of erectile function (International Index of Erectile Function, Sexual Encounter Profile questions 2, 3). Higher scores are better. Multiple domains included within these questionnaires, with different scales for each domain.

  7. Associations between DM severity and standardized questionnaires and outcomes [ Time Frame: Baseline to 6 months ]
    Statistical analysis of changes in length and subjective reports by HbA1c, number of medications, and requirement for insulin.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men with Diabetes Mellitus, Type II
  • 18 years of age or older

Exclusion Criteria:

  • Any evidence of end-organ failure attributed to Diabetes (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03756688


Contacts
Contact: Brett Milazzo 507-538-6151 milazzo.brett@mayo.edu

Locations
United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Brett Milazzo    507-538-6151    milazzo.brett@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Landon W Trost Mayo Clinic

Responsible Party: Landon W. Trost, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03756688     History of Changes
Other Study ID Numbers: 18-006696
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 30, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Penile Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Genital Diseases, Male