Penile Length Restoration in Men With Diabetes Mellitus, Type II

• Sponsor: Mayo Clinic (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03756688
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 48.8
• Patients Per Site Per Month: 2

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention 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)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 (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: Nov 7, 2018
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Penile Length [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 [Baseline to 6 months]

   Records of use from daily journals

2. Patient reported satisfaction with traction therapy [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 [Baseline to 6 months]

   Comprehensive adverse event reporting will be performed at every assessment time point

4. De-novo Peyronie's Disease development [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 [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 [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 [Baseline to 6 months]

   Statistical analysis of changes in length and subjective reports by HbA1c, number of medications, and requirement for insulin.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic

Investigators

• Principal Investigator: Matthew Ziegelmann, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Matthew (Matt) J. Ziegelmann, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03756688
• Other Study ID Numbers: 18-006696
• First Posted: Nov 28, 2018
• Last Update Posted: Dec 6, 2021
• Last Verified: Dec 1, 2021

• 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
• Additional relevant MeSH terms: Penile Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Dec 6, 2021