Penile Length Restoration in Men With Diabetes Mellitus, Type II

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Penile Length Restoration in Men With Diabetes Mellitus, Type II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03756688
• Other study ID #: 18-006696
• Status: Completed
• Phase: N/A
• Start date: November 7, 2018
• Est. completion date: March 18, 2021

Study information

• Verified date: February 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: March 18, 2021
• Est. primary completion date: March 18, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Penile Diseases

Intervention

Device:
• RestoreX PTT - 6 months
Penile traction therapy in straight position for all 6 months.
• RestoreX PTT - 3 months
Penile traction therapy in straight position for first phase (3 months)

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient Compliance With Traction Therapy	Records of use from daily journals	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Mayo Clinic Clinical Trials