Diabetes Mellitus, Type 2, Penile Diseases
Conditions
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.
Interventions
DEVICERestoreX PTT - 6 months
Penile traction therapy in straight position for all 6 months.
DEVICERestoreX PTT - 3 months
Penile traction therapy in straight position for first phase (3 months)
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, 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.
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)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Penile Length Change Between Baseline and Month 6 | 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. Measurements were obtained at baseline and 6 months post-prostatectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Satisfaction With Traction Therapy at 6 Months. | 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 | 3 and 6 months post-prostatectomy | Adverse events were assessed at 3- and 6-months post-prostatectomy, with results summed and reported as a total. |
| Patient Compliance With Traction Therapy | 6 months | Records of use from daily journals |
| Subjective Comparison of Changes in Penile Length | 6 months | 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. | Baseline and 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) |
| Number of Participants With De-novo Peyronie's Disease Development | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Control No treatment will be administered for the entirety of the study (6 months) | 28 |
| Group 2: Treatment PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months) | 28 |
| Group 3: Treatment PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months. | 27 |
| Group 4: Treatment PTT for 30 min 2x day x 6 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months. | 27 |
| Total | 110 |
Baseline characteristics
| Characteristic | Group 1: Control | Group 2: Treatment | Group 3: Treatment | Group 4: Treatment | Total |
|---|---|---|---|---|---|
| Age, Continuous | 53.5 years STANDARD_DEVIATION 7 | 55.1 years STANDARD_DEVIATION 5.3 | 55.0 years STANDARD_DEVIATION 6.3 | 56.2 years STANDARD_DEVIATION 5.4 | 54.9 years STANDARD_DEVIATION 6.1 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 28 Participants | 28 Participants | 27 Participants | 27 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 27 | 0 / 27 |
| other Total, other adverse events | 3 / 28 | 2 / 27 | 4 / 27 |
| serious Total, serious adverse events | 0 / 28 | 0 / 27 | 0 / 27 |
Outcome results
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.
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1: Control | Penile Length Change Between Baseline and Month 6 | 0 Median change from baseline (cm) |
| Group 2: Treatment | Penile Length Change Between Baseline and Month 6 | 0.5 Median change from baseline (cm) |
| Group 3: Treatment | Penile Length Change Between Baseline and Month 6 | 0.5 Median change from baseline (cm) |
| Group 4: Treatment | Penile Length Change Between Baseline and Month 6 | 0.8 Median change from baseline (cm) |
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)
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Control | Erectile Function Among Groups - Evaluating Change From Baseline to 6 Months. | 0 score on a scale | Standard Deviation 3.3 |
| Group 2: Treatment | Erectile Function Among Groups - Evaluating Change From Baseline to 6 Months. | 1.1 score on a scale | Standard Deviation 4.6 |
| Group 3: Treatment | Erectile Function Among Groups - Evaluating Change From Baseline to 6 Months. | 4.2 score on a scale | Standard Deviation 10.4 |
| Group 4: Treatment | Erectile Function Among Groups - Evaluating Change From Baseline to 6 Months. | 4.3 score on a scale | Standard Deviation 9.3 |
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.
Time frame: 3 and 6 months post-prostatectomy
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1: Control | Number of Participants With Adverse Events With Use of RestoreX | Temporary penile pain (mild) | 2 Participants |
| Group 1: Control | Number of Participants With Adverse Events With Use of RestoreX | Pain in other location (unclear if related) | 1 Participants |
| Group 1: Control | Number of Participants With Adverse Events With Use of RestoreX | Temporary erythema / discoloration (mild) | 1 Participants |
| Group 1: Control | Number of Participants With Adverse Events With Use of RestoreX | Temporary decreased sensation (mild) | 0 Participants |
| Group 1: Control | Number of Participants With Adverse Events With Use of RestoreX | Other (unclear if related) | 0 Participants |
| Group 1: Control | Number of Participants With Adverse Events With Use of RestoreX | Temporary bleeding from tape (mild) | 0 Participants |
| Group 2: Treatment | Number of Participants With Adverse Events With Use of RestoreX | Other (unclear if related) | 0 Participants |
| Group 2: Treatment | Number of Participants With Adverse Events With Use of RestoreX | Temporary penile pain (mild) | 2 Participants |
| Group 2: Treatment | Number of Participants With Adverse Events With Use of RestoreX | Temporary bleeding from tape (mild) | 0 Participants |
| Group 2: Treatment | Number of Participants With Adverse Events With Use of RestoreX | Temporary decreased sensation (mild) | 0 Participants |
| Group 2: Treatment | Number of Participants With Adverse Events With Use of RestoreX | Pain in other location (unclear if related) | 0 Participants |
| Group 2: Treatment | Number of Participants With Adverse Events With Use of RestoreX | Temporary erythema / discoloration (mild) | 1 Participants |
| Group 3: Treatment | Number of Participants With Adverse Events With Use of RestoreX | Pain in other location (unclear if related) | 1 Participants |
| Group 3: Treatment | Number of Participants With Adverse Events With Use of RestoreX | Temporary erythema / discoloration (mild) | 4 Participants |
| Group 3: Treatment | Number of Participants With Adverse Events With Use of RestoreX | Temporary bleeding from tape (mild) | 1 Participants |
| Group 3: Treatment | Number of Participants With Adverse Events With Use of RestoreX | Temporary penile pain (mild) | 2 Participants |
| Group 3: Treatment | Number of Participants With Adverse Events With Use of RestoreX | Other (unclear if related) | 1 Participants |
| Group 3: Treatment | Number of Participants With Adverse Events With Use of RestoreX | Temporary decreased sensation (mild) | 1 Participants |
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
Time frame: 6 months
Population: Note that reported events represent subjective reporting of penile curvature.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group 1: Control | Number of Participants With De-novo Peyronie's Disease Development | 1 Participants |
| Group 2: Treatment | Number of Participants With De-novo Peyronie's Disease Development | 2 Participants |
| Group 3: Treatment | Number of Participants With De-novo Peyronie's Disease Development | 1 Participants |
| Group 4: Treatment | Number of Participants With De-novo Peyronie's Disease Development | 1 Participants |
Secondary
Patient Compliance With Traction Therapy
Records of use from daily journals
Time frame: 6 months
Population: No patients were analyzed in the control arm since the outcome measure was assessing compliance with traction therapy (not administered to controls).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 2: Treatment | Patient Compliance With Traction Therapy | 93.5 Percent compliance | Standard Deviation 9.7 |
| Group 3: Treatment | Patient Compliance With Traction Therapy | 91.5 Percent compliance | Standard Deviation 14.3 |
| Group 4: Treatment | Patient Compliance With Traction Therapy | 85.2 Percent compliance | Standard Deviation 21.1 |
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.
Time frame: 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1: Control | Patient Reported Satisfaction With Traction Therapy at 6 Months. | 7.5 score on a scale |
| Group 2: Treatment | Patient Reported Satisfaction With Traction Therapy at 6 Months. | 8 score on a scale |
| Group 3: Treatment | Patient Reported Satisfaction With Traction Therapy at 6 Months. | 8 score on a scale |
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.
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Control | Subjective Comparison of Changes in Penile Length | Subjective improvement in length (% yes) | 0 Percentage of participants |
| Group 1: Control | Subjective Comparison of Changes in Penile Length | Subjective improvement (small) | 0 Percentage of participants |
| Group 1: Control | Subjective Comparison of Changes in Penile Length | Subjective improvement (medium) | 0 Percentage of participants |
| Group 1: Control | Subjective Comparison of Changes in Penile Length | Subjective improvement in length (% unsure) | 0 Percentage of participants |
| Group 1: Control | Subjective Comparison of Changes in Penile Length | Subjective improvement (none) | 100 Percentage of participants |
| Group 1: Control | Subjective Comparison of Changes in Penile Length | Subjective improvement in length (no) | 100 Percentage of participants |
| Group 1: Control | Subjective Comparison of Changes in Penile Length | Subjective improvement (large) | 0 Percentage of participants |
| Group 2: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement (small) | 50 Percentage of participants |
| Group 2: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement (large) | 0 Percentage of participants |
| Group 2: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement in length (no) | 29 Percentage of participants |
| Group 2: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement (medium) | 50 Percentage of participants |
| Group 2: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement (none) | 0 Percentage of participants |
| Group 2: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement in length (% unsure) | 36 Percentage of participants |
| Group 2: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement in length (% yes) | 36 Percentage of participants |
| Group 3: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement (large) | 9 Percentage of participants |
| Group 3: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement in length (% yes) | 63 Percentage of participants |
| Group 3: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement in length (% unsure) | 25 Percentage of participants |
| Group 3: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement in length (no) | 13 Percentage of participants |
| Group 3: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement (medium) | 9 Percentage of participants |
| Group 3: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement (small) | 82 Percentage of participants |
| Group 3: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement (none) | 0 Percentage of participants |
| Group 4: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement in length (no) | 10 Percentage of participants |
| Group 4: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement (none) | 6 Percentage of participants |
| Group 4: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement (small) | 38 Percentage of participants |
| Group 4: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement in length (% unsure) | 25 Percentage of participants |
| Group 4: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement in length (% yes) | 65 Percentage of participants |
| Group 4: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement (medium) | 44 Percentage of participants |
| Group 4: Treatment | Subjective Comparison of Changes in Penile Length | Subjective improvement (large) | 13 Percentage of participants |