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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
110
Penile traction therapy in straight position for all 6 months.
Penile traction therapy in straight position for first phase (3 months)
Mayo Clinic in Rochester
Rochester, Minnesota, United States
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.
Time frame: Baseline to 6 months
Patient Compliance With Traction Therapy
Records of use from daily journals
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 3 and 6 months post-prostatectomy
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
Time frame: 6 months
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.
Time frame: 6 months
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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)
Time frame: Baseline and 6 months