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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Control | No Intervention | No treatment will be administered for the entirety of the study (6 months) | |
| Group 2: Treatment | Experimental | PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months |
|
| Group 3: Treatment | Experimental | PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months |
|
| Group 4: Treatment | Experimental | PTT for 30 min 2x day x 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RestoreX PTT - 6 months | Device | Penile traction therapy in straight position for all 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Compliance With Traction Therapy | Records of use from daily journals | 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. |
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Inclusion Criteria:
- Men with Diabetes Mellitus, Type II
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Ziegelmann, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: Control | No treatment will be administered for the entirety of the study (6 months) |
| FG001 | 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) |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: Control | No treatment will be administered for the entirety of the study (6 months) |
| BG001 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | Median change from baseline (cm) | Baseline to 6 months |
|
Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.
The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transient penile pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Landon Trost | Mayo Clinic | 507-202-1995 | landontrost@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 30, 2020 | Dec 14, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D010409 | Penile Diseases |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Patients will be randomized into one of four groups:
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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.
| RestoreX PTT - 3 months | Device | Penile traction therapy in straight position for first phase (3 months) |
|
| 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. | 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 | 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. | 6 months |
| 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 |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| OG002 | 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. |
| OG003 | 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. |
|
|
| Secondary | Patient Compliance With Traction Therapy | Records of use from daily journals | No patients were analyzed in the control arm since the outcome measure was assessing compliance with traction therapy (not administered to controls). | Posted | Mean | Standard Deviation | Percent compliance | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 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. | Posted | Count of Participants | Participants | 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 | Note that reported events represent subjective reporting of penile curvature. | Posted | Count of Participants | Participants | 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. | Posted | Number | Percentage of participants | 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) | Posted | Mean | Standard Deviation | score on a scale | Baseline and 6 months |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 3 |
| 28 |
| EG001 | 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. | 0 | 27 | 0 | 27 | 2 | 27 |
| EG002 | 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. | 0 | 27 | 0 | 27 | 4 | 27 |
| Transient penile erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Other pain (non-descript location) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Transient decreased penile sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Temporary bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Other (unclear if related) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| Male |
|
|
| Temporary erythema / discoloration (mild) |
|
| Temporary decreased sensation (mild) |
|
| Other (unclear if related) |
|
| Temporary bleeding from tape (mild) |
|
| Subjective improvement in length (% unsure) |
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| Subjective improvement in length (no) |
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| Subjective improvement (large) |
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| Subjective improvement (medium) |
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| Subjective improvement (small) |
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| Subjective improvement (none) |
|