Penile Diseases
Conditions
Brief summary
This clinical trial is designed to assess the safety, dosing, and preliminary efficacy of a novel penile traction device on correcting deformities relating to Peyronie's disease, a condition which results in penile curvature and length loss. The trial is designed as a randomized, placebo-controlled study with men randomized to receiving no therapy or penile traction therapy 30 minutes once, twice, or three times daily. The study will occur over a 3 month period, after which an open label phase for 3 months will be conducted. Final assessments for adverse effects will also be assessed at 9 months.
Detailed description
Peyronie's disease (PD) is a fibrotic condition of the penis, affecting 1-13% of the US male population. The disease results in penile curvature and significant psychosocial bother. Current preferred therapies for PD include repeated penile injections with bacterial enzymes and surgery. However, these therapies are expensive and in some cases result in permanent reductions in penile length and sensation. Penile traction therapy (PTT) is a relatively newer treatment which has been proposed as a treatment for PD with preliminary data suggesting a potential role. However, currently available PTT devices are primarily designed for penile lengthening and have many significant limitations including a requirement of use for 9 hours daily and significant difficulties in personal application. Given these limitations, a new penile traction device (RestoreX® ) was created and funded through Mayo Ventures and was specifically designed to treat men with PD. The primary objective of the current study is to evaluate safety of the device using various dosing schedules, with secondary endpoints designed to assess efficacy and subjective outcomes. To accomplish the study, a population of men from Mayo Clinic with PD will be enrolled and will be randomized to utilize the device for varying amounts of time. Outcomes will be assessed at 3, 6, and 9 months, and results are to be used with the intent to publish in a scientific journal.
Interventions
DEVICERestoreX PTT - randomized and open label
Penile traction therapy in the straight and bent positions
DEVICERestoreX PTT - open label phase only
Penile traction therapy in the straight and bent positions
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Objective outcomes including penile length and curvature will be masked for the investigator and outcome assessor by obtaining photographs of the penis in the lateral and dorsal planes. Curvatures will also be assessed by a clinician in the case where photographs are not able to be obtained or if the participant refuses photographs. These will be assessed without any knowledge as to which grouping the patient is located by two independent reviewers. If there are differences \>5 degrees (curvature), or 0.5 cm (length), a 3rd individual will mediate the difference.
Intervention model description
Men will be randomized into one of four groups: no traction therapy, penile traction 30 minutes once daily, penile traction 30 minutes twice daily, and penile traction 30 minutes three times daily. This treatment will continue for 3 months, after which men will enter an open label phase for 3 months. Primary and secondary outcomes will be evaluated at the completion of the 3 month and 6 month time points. Additional AEs will be assessed at 9 months after study initiation.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Peyronie's disease * Current 30 degree curvature in a single plane (i.e. 20 degrees up, 15 degrees left would not be a candidate) * Not undergoing other therapies for PD currently
Exclusion criteria
* Stretched penile length \<7 cm * Prisoners * Erectile dysfunction unresponsive to phosphodiesterase-5 inhibitors or intracavernosal injection therapies * Diabetes mellitus with evidence of end-organ damage (peripheral neuropathy, retinopathy, chronic kidney disease stage III or higher)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events at Baseline | Baseline | Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other |
| Adverse Events at 3 Months | 3 months | Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other |
| Adverse Events at 6 Months | 6 months | Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other |
| Adverse Events at 9 Months | 9 months | Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Peyronie's Disease Psychological and Physical Domain on Peyronie's Disease Questionnaire (PDQ) | Baseline, 3 months | Self reported Peyronie's Disease questionnaire (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions with a total score range 0 to 24. Negative denotes improvement. |
| Change in Peyronie's Disease Penile Pain Domain on Peyronie's Disease Questionnaire (PDQ) | Baseline, 3 months | Self reported Peyronie's Disease questionnaire penile pain scale range 0 (no pain) and 10 (extreme pain) on 3 questions with a total score range 0 to 30. Negative denotes improvement. |
| Change in Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) | Baseline, 3 month | Self reported Peyronie's Disease questionnaire bother score range 0 (no issue or not at all bothered) and 4 (extremely bothered) on 4 questions with a total score range 0 to 16. Negative denotes improvement. |
| Change in Penile Length to Corona | 3 months, 6 months | Stretched penile length measured in centimeters from pubic symphysis to glanular corona |
| Ability to Achieve Sexual Intercourse | 3 months | Change from no to yes on the self reported standardized sexual encounter profile questions 2 able to penetrate |
| Satisfaction With the RestoreX® Device to Alternative Forms of PTT | 3 months | Self reported satisfaction with how RestoreX® compares to other devices on a scale of much better, somewhat better, equal, somewhat worse, much worse |
| Satisfaction With the RestoreX® Device to Alternative PD Therapies | 3 months | Subjects being treated for PD the first time were asked which therapies they would choose. Respondents could select more than 1 option so values equal greater than 100%. |
| Overall Treatment Satisfaction | 3 months | Self reported satisfaction of penile traction therapy on a scale of very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, very dissatisfied |
| Change in Penile Length to Tip | 3 months, 6 months | Stretched penile length measured in centimeters from pubic symphysis to penile tip |
| Change in Penile Curvature | 3 months, 6 months | Subjects received Trimix to achieve pharmacological erection and curvature was measured in degrees. A negative result denotes an improvement in curvature. |
| Change Erectile Function | 3 months, 6 months | Self reported International Index of Erectile Function (IIEF) questionnaire for erectile dysfunction (ED) scored on a scale of \<11 severe ED, 11-16 moderate ED, 17-25 mild ED, 26-30 no ED. Questionnaires were given to participants at baseline, 3 months and 6 months. Change in the score was reported for 3 months and 6 months. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group No treatment will be administered for the initial 3 months. After the 3 month period of time, this group will enter an open label phase where they may utilize a penile traction device if desired. | 28 |
| Penile Traction Therapy Group 1x Daily x 3 Months Men will utilize penile traction therapy for 30 minutes once daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired. | 27 |
| Penile Traction Therapy Group 2x Daily x 3 Months Men will utilize penile traction therapy for 30 minutes twice daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired. | 28 |
| Penile Traction Therapy Group 3x Daily x 3 Months Men will utilize penile traction therapy for 30 minutes three times daily for the initial 3 months. After this phase is completed, they will enter an open label phase for 3 months where they may utilize the device as much or as little as desired. | 27 |
| Total | 110 |
Baseline characteristics
| Characteristic | Penile Traction Therapy Group 3x Daily x 3 Months | Total | Control Group | Penile Traction Therapy Group 1x Daily x 3 Months | Penile Traction Therapy Group 2x Daily x 3 Months |
|---|---|---|---|---|---|
| Age, Continuous | 60.0 years STANDARD_DEVIATION 5.5 | 58.4 years STANDARD_DEVIATION 7.8 | 58.1 years STANDARD_DEVIATION 9.7 | 56.6 years STANDARD_DEVIATION 8.3 | 59.0 years STANDARD_DEVIATION 6.9 |
| Race and Ethnicity Not Collected | — | 0 Participants | — | — | — |
| Region of Enrollment United States | 27 participants | 110 participants | 28 participants | 27 participants | 28 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 27 Participants | 110 Participants | 28 Participants | 27 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 28 | 0 / 27 | 0 / 63 |
| other Total, other adverse events | 16 / 27 | 15 / 28 | 13 / 27 | 28 / 63 |
| serious Total, serious adverse events | 0 / 27 | 0 / 28 | 0 / 27 | 0 / 63 |
Outcome results
Primary
Adverse Events at 3 Months
Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other
Time frame: 3 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Penile Traction Therapy Group 1x Daily x 3 Months | Adverse Events at 3 Months | Transient Sensory Changes | 10 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Adverse Events at 3 Months | Transient Erythema | 43 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Adverse Events at 3 Months | Transient Discomfort | 33 percentage of participants |
| Penile Traction Therapy Group 2x Daily x 3 Months | Adverse Events at 3 Months | Transient Sensory Changes | 14 percentage of participants |
| Penile Traction Therapy Group 2x Daily x 3 Months | Adverse Events at 3 Months | Transient Erythema | 41 percentage of participants |
| Penile Traction Therapy Group 2x Daily x 3 Months | Adverse Events at 3 Months | Transient Discomfort | 50 percentage of participants |
| Penile Traction Therapy Group 3x Daily x 3 Months | Adverse Events at 3 Months | Transient Erythema | 37 percentage of participants |
| Penile Traction Therapy Group 3x Daily x 3 Months | Adverse Events at 3 Months | Transient Discomfort | 37 percentage of participants |
| Penile Traction Therapy Group 3x Daily x 3 Months | Adverse Events at 3 Months | Transient Sensory Changes | 16 percentage of participants |
Primary
Adverse Events at 6 Months
Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other
Time frame: 6 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Penile Traction Therapy Group 1x Daily x 3 Months | Adverse Events at 6 Months | Penile erythema or discoloration | 35 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Adverse Events at 6 Months | Loss or abnormal penile sensation | 5 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Adverse Events at 6 Months | New penile pain, Mild | 27 percentage of participants |
Primary
Adverse Events at 9 Months
Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other
Time frame: 9 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Penile Traction Therapy Group 1x Daily x 3 Months | Adverse Events at 9 Months | New penile pain, Mild | 4 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Adverse Events at 9 Months | Penile erythema or discoloration | 4 percentage of participants |
Primary
Adverse Events at Baseline
Percentage of participants being treated with penile traction to experience adverse events relating to device use defined by redness, pain, swelling, new bumps, discoloration, sensation loss, abnormal sensation or other
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Penile Traction Therapy Group 1x Daily x 3 Months | Adverse Events at Baseline | Penile erythema or discoloration | 2 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Adverse Events at Baseline | Loss or abnormal penile sensation | 7 percentage of participants |
| Penile Traction Therapy Group 2x Daily x 3 Months | Adverse Events at Baseline | Penile erythema or discoloration | 2 percentage of participants |
| Penile Traction Therapy Group 2x Daily x 3 Months | Adverse Events at Baseline | Loss or abnormal penile sensation | 10 percentage of participants |
| Penile Traction Therapy Group 3x Daily x 3 Months | Adverse Events at Baseline | Penile erythema or discoloration | 1 percentage of participants |
| Penile Traction Therapy Group 3x Daily x 3 Months | Adverse Events at Baseline | Loss or abnormal penile sensation | 7 percentage of participants |
Secondary
Ability to Achieve Sexual Intercourse
Change from no to yes on the self reported standardized sexual encounter profile questions 2 able to penetrate
Time frame: 3 months
Population: It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Penile Traction Therapy Group 1x Daily x 3 Months | Ability to Achieve Sexual Intercourse | 0 percentage of participants |
| Penile Traction Therapy Group 2x Daily x 3 Months | Ability to Achieve Sexual Intercourse | 4 percentage of participants |
Secondary
Ability to Achieve Sexual Intercourse
Change from no to yes on the self reported standardized sexual encounter profile questions 2 able to penetrate
Time frame: 6 months
Population: It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Penile Traction Therapy Group 1x Daily x 3 Months | Ability to Achieve Sexual Intercourse | 0 percentage of participants |
| Penile Traction Therapy Group 2x Daily x 3 Months | Ability to Achieve Sexual Intercourse | 4 percentage of participants |
Secondary
Change Erectile Function
Self reported International Index of Erectile Function (IIEF) questionnaire for erectile dysfunction (ED) scored on a scale of \<11 severe ED, 11-16 moderate ED, 17-25 mild ED, 26-30 no ED. Questionnaires were given to participants at baseline, 3 months and 6 months. Change in the score was reported for 3 months and 6 months.
Time frame: 3 months, 6 months
Population: It was pre-specified to combine Penile Traction Therapy Groups for this analysis. Questionnaire 26 subjects control group and 59 subjects PTT group available for analysis 3 mo. Questionnaire 14 subjects original control group and 37 subjects original PTT group available for analysis 6 mo.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Penile Traction Therapy Group 1x Daily x 3 Months | Change Erectile Function | 3 months | -1.3 units on a scale | Standard Deviation 6.7 |
| Penile Traction Therapy Group 1x Daily x 3 Months | Change Erectile Function | 6 months | 1.8 units on a scale | Standard Deviation 4.4 |
| Penile Traction Therapy Group 2x Daily x 3 Months | Change Erectile Function | 3 months | 2.5 units on a scale | Standard Deviation 6.3 |
| Penile Traction Therapy Group 2x Daily x 3 Months | Change Erectile Function | 6 months | 4.4 units on a scale | Standard Deviation 7.4 |
Comparison: Control group vs Penile Traction Therapy Group at 3 monthsp-value: 0.06Wilcoxon (Mann-Whitney)
Comparison: Control group vs Penile Traction Therapy Group at 6 monthsp-value: 0.66Wilcoxon (Mann-Whitney)
Secondary
Change in Penile Curvature
Subjects received Trimix to achieve pharmacological erection and curvature was measured in degrees. A negative result denotes an improvement in curvature.
Time frame: 3 months, 6 months
Population: It was pre-specified to combine Penile Traction Therapy Groups for this analysis. Data for 27 subjects control group and 62 subjects PTT group available for analysis at 3 mo. Data for 14 subjects original control group and 37 subjects original PTT group available for analysis at 6 mo.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Penile Traction Therapy Group 1x Daily x 3 Months | Change in Penile Curvature | 3 months | 1.3 degrees | Standard Deviation 19 |
| Penile Traction Therapy Group 1x Daily x 3 Months | Change in Penile Curvature | 6 months | -12.5 degrees | Standard Deviation 18.6 |
| Penile Traction Therapy Group 2x Daily x 3 Months | Change in Penile Curvature | 3 months | -11.7 degrees | Standard Deviation 15 |
| Penile Traction Therapy Group 2x Daily x 3 Months | Change in Penile Curvature | 6 months | -14.9 degrees | Standard Deviation 18.1 |
Comparison: Control group vs Penile Traction Therapy Group at 3 monthsp-value: 0.01Wilcoxon (Mann-Whitney)
Comparison: Control group vs. Penile Traction Therapy Group at 6 monthsp-value: 0.64Wilcoxon (Mann-Whitney)
Secondary
Change in Penile Length to Corona
Stretched penile length measured in centimeters from pubic symphysis to glanular corona
Time frame: 3 months, 6 months
Population: It was pre-specified to combine Penile Traction Therapy Groups for this analysis. Data for 27 subjects control group and 62 subjects PTT group available for analysis at 3 mo. Data for 14 subjects original control group and 37 subjects original PTT group available for analysis at 6 mo.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Penile Traction Therapy Group 1x Daily x 3 Months | Change in Penile Length to Corona | 3 month | 0.3 Centimeters | Standard Deviation 0.8 |
| Penile Traction Therapy Group 1x Daily x 3 Months | Change in Penile Length to Corona | 6 month | 2.0 Centimeters | Standard Deviation 1.1 |
| Penile Traction Therapy Group 2x Daily x 3 Months | Change in Penile Length to Corona | 3 month | 1.3 Centimeters | Standard Deviation 1.1 |
| Penile Traction Therapy Group 2x Daily x 3 Months | Change in Penile Length to Corona | 6 month | 2.3 Centimeters | Standard Deviation 2 |
Comparison: Control group vs Penile Traction Therapy Group at 3 monthsp-value: 0.001Wilcoxon (Mann-Whitney)
Comparison: Control group vs Penile Traction Therapy Group at 6 monthsp-value: 0.9Wilcoxon (Mann-Whitney)
Secondary
Change in Penile Length to Tip
Stretched penile length measured in centimeters from pubic symphysis to penile tip
Time frame: 3 months, 6 months
Population: It was pre-specified to combine Penile Traction Therapy Groups for this analysis. Data for 27 subjects control group and 62 subjects PTT group available for analysis at 3 mo. Data for 14 subjects original control group and 37 subjects original PTT group available for analysis at 6 mo.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Penile Traction Therapy Group 1x Daily x 3 Months | Change in Penile Length to Tip | 3 months | 0.0 Centimeters | Standard Deviation 0.7 |
| Penile Traction Therapy Group 1x Daily x 3 Months | Change in Penile Length to Tip | 6 months | 1.6 Centimeters | Standard Deviation 1.2 |
| Penile Traction Therapy Group 2x Daily x 3 Months | Change in Penile Length to Tip | 3 months | 1.5 Centimeters | Standard Deviation 1.1 |
| Penile Traction Therapy Group 2x Daily x 3 Months | Change in Penile Length to Tip | 6 months | 1.9 Centimeters | Standard Deviation 1.3 |
Comparison: Control group vs Penile Traction Therapy Group at 3 monthsp-value: 0.001Wilcoxon (Mann-Whitney)
Comparison: Control group vs. Penile Traction Therapy Group at 6 monthsp-value: 0.4Wilcoxon (Mann-Whitney)
Secondary
Change in Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)
Self reported Peyronie's Disease questionnaire bother score range 0 (no issue or not at all bothered) and 4 (extremely bothered) on 4 questions with a total score range 0 to 16. Negative denotes improvement.
Time frame: Baseline, 3 month
Population: It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Penile Traction Therapy Group 1x Daily x 3 Months | Change in Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) | -0.9 units on a scale | Standard Deviation 4.2 |
| Penile Traction Therapy Group 2x Daily x 3 Months | Change in Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ) | -2.4 units on a scale | Standard Deviation 3.4 |
p-value: 0.07Wilcoxon (Mann-Whitney)
Secondary
Change in Peyronie's Disease Penile Pain Domain on Peyronie's Disease Questionnaire (PDQ)
Self reported Peyronie's Disease questionnaire penile pain scale range 0 (no pain) and 10 (extreme pain) on 3 questions with a total score range 0 to 30. Negative denotes improvement.
Time frame: Baseline, 3 months
Population: It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Penile Traction Therapy Group 1x Daily x 3 Months | Change in Peyronie's Disease Penile Pain Domain on Peyronie's Disease Questionnaire (PDQ) | -0.8 units on a scale | Standard Deviation 3.6 |
| Penile Traction Therapy Group 2x Daily x 3 Months | Change in Peyronie's Disease Penile Pain Domain on Peyronie's Disease Questionnaire (PDQ) | -1.4 units on a scale | Standard Deviation 3.2 |
p-value: 0.26Wilcoxon (Mann-Whitney)
Secondary
Change in Peyronie's Disease Psychological and Physical Domain on Peyronie's Disease Questionnaire (PDQ)
Self reported Peyronie's Disease questionnaire (physical and psychological) severity score range 0 (none) to 4 (very severe) on 6 questions with a total score range 0 to 24. Negative denotes improvement.
Time frame: Baseline, 3 months
Population: It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Penile Traction Therapy Group 1x Daily x 3 Months | Change in Peyronie's Disease Psychological and Physical Domain on Peyronie's Disease Questionnaire (PDQ) | -0.6 units on a scale | Standard Deviation 3.3 |
| Penile Traction Therapy Group 2x Daily x 3 Months | Change in Peyronie's Disease Psychological and Physical Domain on Peyronie's Disease Questionnaire (PDQ) | -2.3 units on a scale | Standard Deviation 4.1 |
p-value: 0.09Wilcoxon (Mann-Whitney)
Secondary
Overall Treatment Satisfaction
Self reported satisfaction of penile traction therapy on a scale of very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, very dissatisfied
Time frame: 3 months
Population: It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Penile Traction Therapy Group 1x Daily x 3 Months | Overall Treatment Satisfaction | % Neutral | 30.2 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Overall Treatment Satisfaction | % Very Satisfied | 25.4 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Overall Treatment Satisfaction | % Somewhat satisfied | 41.3 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Overall Treatment Satisfaction | % Somewhat dissatisfied | 3.2 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Overall Treatment Satisfaction | % Very dissatisfied | 0 percentage of participants |
Secondary
Satisfaction With the RestoreX® Device to Alternative Forms of PTT
Self reported satisfaction with how RestoreX® compares to other devices on a scale of much better, somewhat better, equal, somewhat worse, much worse
Time frame: 3 months
Population: It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Penile Traction Therapy Group 1x Daily x 3 Months | Satisfaction With the RestoreX® Device to Alternative Forms of PTT | % RestoreX is much better | 86.7 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Satisfaction With the RestoreX® Device to Alternative Forms of PTT | % RestoreX is somewhat better | 13.3 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Satisfaction With the RestoreX® Device to Alternative Forms of PTT | % Both are equal | 0 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Satisfaction With the RestoreX® Device to Alternative Forms of PTT | % RestoreX is somewhat worse | 0 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Satisfaction With the RestoreX® Device to Alternative Forms of PTT | % RestoreX is much worse | 0 percentage of participants |
Secondary
Satisfaction With the RestoreX® Device to Alternative PD Therapies
Subjects being treated for PD the first time were asked which therapies they would choose. Respondents could select more than 1 option so values equal greater than 100%.
Time frame: 3 months
Population: It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Penile Traction Therapy Group 1x Daily x 3 Months | Satisfaction With the RestoreX® Device to Alternative PD Therapies | RestoreX | 74.1 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Satisfaction With the RestoreX® Device to Alternative PD Therapies | Collagenase clostridium histolyticum | 23.6 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Satisfaction With the RestoreX® Device to Alternative PD Therapies | Oral pills | 14.8 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Satisfaction With the RestoreX® Device to Alternative PD Therapies | Vacuum erection device | 5.6 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Satisfaction With the RestoreX® Device to Alternative PD Therapies | Surgery | 1.8 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Satisfaction With the RestoreX® Device to Alternative PD Therapies | Other therapy | 1.8 percentage of participants |
| Penile Traction Therapy Group 1x Daily x 3 Months | Satisfaction With the RestoreX® Device to Alternative PD Therapies | Other traction device | 0 percentage of participants |