Trial Outcomes & Findings for Efficacy of Penile Traction Therapy Using a Novel Device (NCT NCT03389854)
NCT ID: NCT03389854
Last Updated: 2020-08-12
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
Baseline
Results posted on
2020-08-12
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
28
|
27
|
|
Overall Study
COMPLETED
|
27
|
21
|
23
|
19
|
|
Overall Study
NOT COMPLETED
|
1
|
6
|
5
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Control Group
n=28 Participants
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.
|
Penile Traction Therapy Group 1x Daily x 3 Months
n=27 Participants
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.
|
Penile Traction Therapy Group 2x Daily x 3 Months
n=28 Participants
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.
|
Penile Traction Therapy Group 3x Daily x 3 Months
n=27 Participants
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.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 9.7 • n=28 Participants
|
56.6 years
STANDARD_DEVIATION 8.3 • n=27 Participants
|
59.0 years
STANDARD_DEVIATION 6.9 • n=28 Participants
|
60.0 years
STANDARD_DEVIATION 5.5 • n=27 Participants
|
58.4 years
STANDARD_DEVIATION 7.8 • n=110 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=28 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=110 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=28 Participants
|
27 Participants
n=27 Participants
|
28 Participants
n=28 Participants
|
27 Participants
n=27 Participants
|
110 Participants
n=110 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
28 participants
n=28 Participants
|
27 participants
n=27 Participants
|
28 participants
n=28 Participants
|
27 participants
n=27 Participants
|
110 participants
n=110 Participants
|
PRIMARY outcome
Timeframe: BaselinePercentage 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
Outcome measures
| Measure |
Penile Traction Therapy Group 1x Daily x 3 Months
n=27 Participants
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.
|
Penile Traction Therapy Group 2x Daily x 3 Months
n=28 Participants
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.
|
Penile Traction Therapy Group 3x Daily x 3 Months
n=27 Participants
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.
|
|---|---|---|---|
|
Adverse Events at Baseline
Penile erythema or discoloration
|
2 percentage of participants
|
2 percentage of participants
|
1 percentage of participants
|
|
Adverse Events at Baseline
Loss or abnormal penile sensation
|
7 percentage of participants
|
10 percentage of participants
|
7 percentage of participants
|
PRIMARY outcome
Timeframe: 3 monthsPercentage 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
Outcome measures
| Measure |
Penile Traction Therapy Group 1x Daily x 3 Months
n=27 Participants
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.
|
Penile Traction Therapy Group 2x Daily x 3 Months
n=28 Participants
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.
|
Penile Traction Therapy Group 3x Daily x 3 Months
n=27 Participants
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.
|
|---|---|---|---|
|
Adverse Events at 3 Months
Transient Sensory Changes
|
10 percentage of participants
|
14 percentage of participants
|
16 percentage of participants
|
|
Adverse Events at 3 Months
Transient Discomfort
|
33 percentage of participants
|
50 percentage of participants
|
37 percentage of participants
|
|
Adverse Events at 3 Months
Transient Erythema
|
43 percentage of participants
|
41 percentage of participants
|
37 percentage of participants
|
PRIMARY outcome
Timeframe: 6 monthsPercentage 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
Outcome measures
| Measure |
Penile Traction Therapy Group 1x Daily x 3 Months
n=63 Participants
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.
|
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.
|
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.
|
|---|---|---|---|
|
Adverse Events at 6 Months
Penile erythema or discoloration
|
35 percentage of participants
|
—
|
—
|
|
Adverse Events at 6 Months
Loss or abnormal penile sensation
|
5 percentage of participants
|
—
|
—
|
|
Adverse Events at 6 Months
New penile pain, Mild
|
27 percentage of participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 9 monthsPercentage 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
Outcome measures
| Measure |
Penile Traction Therapy Group 1x Daily x 3 Months
n=57 Participants
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.
|
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.
|
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.
|
|---|---|---|---|
|
Adverse Events at 9 Months
Penile erythema or discoloration
|
4 percentage of participants
|
—
|
—
|
|
Adverse Events at 9 Months
New penile pain, Mild
|
4 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months, 6 monthsPopulation: 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.
Stretched penile length measured in centimeters from pubic symphysis to glanular corona
Outcome measures
| Measure |
Penile Traction Therapy Group 1x Daily x 3 Months
n=27 Participants
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.
|
Penile Traction Therapy Group 2x Daily x 3 Months
n=62 Participants
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.
|
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.
|
|---|---|---|---|
|
Change in Penile Length to Corona
3 month
|
0.3 Centimeters
Standard Deviation 0.8
|
1.3 Centimeters
Standard Deviation 1.1
|
—
|
|
Change in Penile Length to Corona
6 month
|
2.0 Centimeters
Standard Deviation 1.1
|
2.3 Centimeters
Standard Deviation 2.0
|
—
|
SECONDARY outcome
Timeframe: 3 months, 6 monthsPopulation: 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.
Stretched penile length measured in centimeters from pubic symphysis to penile tip
Outcome measures
| Measure |
Penile Traction Therapy Group 1x Daily x 3 Months
n=27 Participants
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.
|
Penile Traction Therapy Group 2x Daily x 3 Months
n=62 Participants
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.
|
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.
|
|---|---|---|---|
|
Change in Penile Length to Tip
3 months
|
0.0 Centimeters
Standard Deviation 0.7
|
1.5 Centimeters
Standard Deviation 1.1
|
—
|
|
Change in Penile Length to Tip
6 months
|
1.6 Centimeters
Standard Deviation 1.2
|
1.9 Centimeters
Standard Deviation 1.3
|
—
|
SECONDARY outcome
Timeframe: 3 months, 6 monthsPopulation: 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.
Subjects received Trimix to achieve pharmacological erection and curvature was measured in degrees. A negative result denotes an improvement in curvature.
Outcome measures
| Measure |
Penile Traction Therapy Group 1x Daily x 3 Months
n=27 Participants
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.
|
Penile Traction Therapy Group 2x Daily x 3 Months
n=62 Participants
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.
|
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.
|
|---|---|---|---|
|
Change in Penile Curvature
3 months
|
1.3 degrees
Standard Deviation 19.0
|
-11.7 degrees
Standard Deviation 15
|
—
|
|
Change in Penile Curvature
6 months
|
-12.5 degrees
Standard Deviation 18.6
|
-14.9 degrees
Standard Deviation 18.1
|
—
|
SECONDARY outcome
Timeframe: 3 months, 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Penile Traction Therapy Group 1x Daily x 3 Months
n=26 Participants
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.
|
Penile Traction Therapy Group 2x Daily x 3 Months
n=59 Participants
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.
|
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.
|
|---|---|---|---|
|
Change Erectile Function
3 months
|
-1.3 units on a scale
Standard Deviation 6.7
|
2.5 units on a scale
Standard Deviation 6.3
|
—
|
|
Change Erectile Function
6 months
|
1.8 units on a scale
Standard Deviation 4.4
|
4.4 units on a scale
Standard Deviation 7.4
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
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.
Outcome measures
| Measure |
Penile Traction Therapy Group 1x Daily x 3 Months
n=23 Participants
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.
|
Penile Traction Therapy Group 2x Daily x 3 Months
n=59 Participants
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.
|
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.
|
|---|---|---|---|
|
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
|
-2.3 units on a scale
Standard Deviation 4.1
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
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.
Outcome measures
| Measure |
Penile Traction Therapy Group 1x Daily x 3 Months
n=23 Participants
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.
|
Penile Traction Therapy Group 2x Daily x 3 Months
n=59 Participants
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.
|
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.
|
|---|---|---|---|
|
Change in Peyronie's Disease Penile Pain Domain on Peyronie's Disease Questionnaire (PDQ)
|
-0.8 units on a scale
Standard Deviation 3.6
|
-1.4 units on a scale
Standard Deviation 3.2
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 monthPopulation: It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
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.
Outcome measures
| Measure |
Penile Traction Therapy Group 1x Daily x 3 Months
n=23 Participants
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.
|
Penile Traction Therapy Group 2x Daily x 3 Months
n=59 Participants
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.
|
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.
|
|---|---|---|---|
|
Change in Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)
|
-0.9 units on a scale
Standard Deviation 4.2
|
-2.4 units on a scale
Standard Deviation 3.4
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
Self reported satisfaction of penile traction therapy on a scale of very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, very dissatisfied
Outcome measures
| Measure |
Penile Traction Therapy Group 1x Daily x 3 Months
n=63 Participants
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Treatment Satisfaction
% Very Satisfied
|
25.4 percentage of participants
|
—
|
—
|
|
Overall Treatment Satisfaction
% Somewhat satisfied
|
41.3 percentage of participants
|
—
|
—
|
|
Overall Treatment Satisfaction
% Neutral
|
30.2 percentage of participants
|
—
|
—
|
|
Overall Treatment Satisfaction
% Somewhat dissatisfied
|
3.2 percentage of participants
|
—
|
—
|
|
Overall Treatment Satisfaction
% Very dissatisfied
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
Change from no to yes on the self reported standardized sexual encounter profile questions 2 "able to penetrate"
Outcome measures
| Measure |
Penile Traction Therapy Group 1x Daily x 3 Months
n=24 Participants
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.
|
Penile Traction Therapy Group 2x Daily x 3 Months
n=48 Participants
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.
|
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.
|
|---|---|---|---|
|
Ability to Achieve Sexual Intercourse
|
0 percentage of participants
|
4 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
Self reported satisfaction with how RestoreX® compares to other devices on a scale of much better, somewhat better, equal, somewhat worse, much worse
Outcome measures
| Measure |
Penile Traction Therapy Group 1x Daily x 3 Months
n=15 Participants
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.
|
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.
|
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.
|
|---|---|---|---|
|
Satisfaction With the RestoreX® Device to Alternative Forms of PTT
% RestoreX is much better
|
86.7 percentage of participants
|
—
|
—
|
|
Satisfaction With the RestoreX® Device to Alternative Forms of PTT
% RestoreX is somewhat better
|
13.3 percentage of participants
|
—
|
—
|
|
Satisfaction With the RestoreX® Device to Alternative Forms of PTT
% Both are equal
|
0 percentage of participants
|
—
|
—
|
|
Satisfaction With the RestoreX® Device to Alternative Forms of PTT
% RestoreX is somewhat worse
|
0 percentage of participants
|
—
|
—
|
|
Satisfaction With the RestoreX® Device to Alternative Forms of PTT
% RestoreX is much worse
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
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%.
Outcome measures
| Measure |
Penile Traction Therapy Group 1x Daily x 3 Months
n=54 Participants
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.
|
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.
|
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.
|
|---|---|---|---|
|
Satisfaction With the RestoreX® Device to Alternative PD Therapies
RestoreX
|
74.1 percentage of participants
|
—
|
—
|
|
Satisfaction With the RestoreX® Device to Alternative PD Therapies
Collagenase clostridium histolyticum
|
23.6 percentage of participants
|
—
|
—
|
|
Satisfaction With the RestoreX® Device to Alternative PD Therapies
Oral pills
|
14.8 percentage of participants
|
—
|
—
|
|
Satisfaction With the RestoreX® Device to Alternative PD Therapies
Vacuum erection device
|
5.6 percentage of participants
|
—
|
—
|
|
Satisfaction With the RestoreX® Device to Alternative PD Therapies
Surgery
|
1.8 percentage of participants
|
—
|
—
|
|
Satisfaction With the RestoreX® Device to Alternative PD Therapies
Other therapy
|
1.8 percentage of participants
|
—
|
—
|
|
Satisfaction With the RestoreX® Device to Alternative PD Therapies
Other traction device
|
0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
Change from no to yes on the self reported standardized sexual encounter profile questions 2 "able to penetrate"
Outcome measures
| Measure |
Penile Traction Therapy Group 1x Daily x 3 Months
n=14 Participants
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.
|
Penile Traction Therapy Group 2x Daily x 3 Months
n=37 Participants
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.
|
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.
|
|---|---|---|---|
|
Ability to Achieve Sexual Intercourse
|
0 percentage of participants
|
4 percentage of participants
|
—
|
Adverse Events
Penile Traction Therapy Group 1x Daily x 3 Months
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Penile Traction Therapy Group 2x Daily x 3 Months
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Penile Traction Therapy Group 3x Daily x 3 Months
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Open Label Period Penile Traction Therapy
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Penile Traction Therapy Group 1x Daily x 3 Months
n=27 participants at risk
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.
|
Penile Traction Therapy Group 2x Daily x 3 Months
n=28 participants at risk
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.
|
Penile Traction Therapy Group 3x Daily x 3 Months
n=27 participants at risk
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.
|
Open Label Period Penile Traction Therapy
n=63 participants at risk
After the initial 3 month study period subjects from both the control group and the penile traction therapy group will enter an open label phase for 3 months where they may utilize the device as much or as little as desired.
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Penile erythema or discoloration, transient
|
44.4%
12/27 • Number of events 12 • Adverse events were collected over a 9 month period for each subject receiving penile traction therapy.
|
42.9%
12/28 • Number of events 12 • Adverse events were collected over a 9 month period for each subject receiving penile traction therapy.
|
37.0%
10/27 • Number of events 10 • Adverse events were collected over a 9 month period for each subject receiving penile traction therapy.
|
38.1%
24/63 • Number of events 24 • Adverse events were collected over a 9 month period for each subject receiving penile traction therapy.
|
|
Reproductive system and breast disorders
Loss or abnormal penile sensation, transient (new onset for 6-, 9-month cohorts)
|
11.1%
3/27 • Number of events 3 • Adverse events were collected over a 9 month period for each subject receiving penile traction therapy.
|
14.3%
4/28 • Number of events 4 • Adverse events were collected over a 9 month period for each subject receiving penile traction therapy.
|
14.8%
4/27 • Number of events 4 • Adverse events were collected over a 9 month period for each subject receiving penile traction therapy.
|
4.8%
3/63 • Number of events 3 • Adverse events were collected over a 9 month period for each subject receiving penile traction therapy.
|
|
Reproductive system and breast disorders
New penile pain, transient (mild)
|
33.3%
9/27 • Number of events 9 • Adverse events were collected over a 9 month period for each subject receiving penile traction therapy.
|
50.0%
14/28 • Number of events 14 • Adverse events were collected over a 9 month period for each subject receiving penile traction therapy.
|
37.0%
10/27 • Number of events 10 • Adverse events were collected over a 9 month period for each subject receiving penile traction therapy.
|
30.2%
19/63 • Number of events 19 • Adverse events were collected over a 9 month period for each subject receiving penile traction therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place