Penile Length Restoration in Men With Diabetes Mellitus, Type II
Primary Purpose
Diabetes Mellitus, Type 2, Penile Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RestoreX PTT - 6 months
RestoreX PTT - 3 months
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility 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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Experimental
Experimental
Experimental
Arm Label
Group 1: Control
Group 2: Treatment
Group 3: Treatment
Group 4: Treatment
Arm Description
No treatment will be administered for the entirety of the study (6 months)
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Patient Compliance With Traction Therapy
Records of use from daily journals
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.
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.
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
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.
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03756688
Brief Title
Penile Length Restoration in Men With Diabetes Mellitus, Type II
Official Title
Penile Length Restoration in Men With Diabetes Mellitus, Type II
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 7, 2018 (Actual)
Primary Completion Date
March 18, 2021 (Actual)
Study Completion Date
March 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Penile Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
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)
Masking
Care ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Control
Arm Type
No Intervention
Arm Description
No treatment will be administered for the entirety of the study (6 months)
Arm Title
Group 2: Treatment
Arm Type
Experimental
Arm Description
PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months
Arm Title
Group 3: Treatment
Arm Type
Experimental
Arm Description
PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months
Arm Title
Group 4: Treatment
Arm Type
Experimental
Arm Description
PTT for 30 min 2x day x 6 months
Intervention Type
Device
Intervention Name(s)
RestoreX PTT - 6 months
Intervention Description
Penile traction therapy in straight position for all 6 months.
Intervention Type
Device
Intervention Name(s)
RestoreX PTT - 3 months
Intervention Description
Penile traction therapy in straight position for first phase (3 months)
Primary Outcome Measure Information:
Title
Penile Length Change Between Baseline and Month 6
Description
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.
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Patient Compliance With Traction Therapy
Description
Records of use from daily journals
Time Frame
6 months
Title
Patient Reported Satisfaction With Traction Therapy at 6 Months.
Description
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.
Time Frame
6 months
Title
Number of Participants With Adverse Events With Use of RestoreX
Description
Adverse events were assessed at 3- and 6-months post-prostatectomy, with results summed and reported as a total.
Time Frame
3 and 6 months post-prostatectomy
Title
Number of Participants With De-novo Peyronie's Disease Development
Description
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
Time Frame
6 months
Title
Subjective Comparison of Changes in Penile Length
Description
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.
Time Frame
6 months
Title
Erectile Function Among Groups - Evaluating Change From Baseline to 6 Months.
Description
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)
Time Frame
Baseline and 6 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Ziegelmann, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Penile Length Restoration in Men With Diabetes Mellitus, Type II
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