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Efficacy of Penile Traction Therapy Using a Novel Device

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03389854
Recruitment Status : Completed
First Posted : January 4, 2018
Results First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Landon W. Trost, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Penile Diseases
Interventions Device: RestoreX PTT - randomized and open label
Device: RestoreX PTT - open label phase only
Enrollment 110
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group Penile Traction Therapy Group 1x Daily x 3 Months Penile Traction Therapy Group 2x Daily x 3 Months Penile Traction Therapy Group 3x Daily x 3 Months
Hide Arm/Group Description 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. 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. 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. 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.
Period Title: Overall Study
Started 28 27 28 27
Completed 27 21 23 19
Not Completed 1 6 5 8
Arm/Group Title Control Group Penile Traction Therapy Group 1x Daily x 3 Months Penile Traction Therapy Group 2x Daily x 3 Months Penile Traction Therapy Group 3x Daily x 3 Months Total
Hide Arm/Group Description 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 28 27 28 27 110
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 27 participants 28 participants 27 participants 110 participants
58.1  (9.7) 56.6  (8.3) 59.0  (6.9) 60.0  (5.5) 58.4  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 27 participants 28 participants 27 participants 110 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
28
 100.0%
27
 100.0%
28
 100.0%
27
 100.0%
110
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 27 participants 28 participants 27 participants 110 participants
28 27 28 27 110
1.Primary Outcome
Title Adverse Events at Baseline
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Penile Traction Therapy Group 1x Daily x 3 Months Penile Traction Therapy Group 2x Daily x 3 Months Penile Traction Therapy Group 3x Daily x 3 Months
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 27 28 27
Measure Type: Number
Unit of Measure: percentage of participants
Penile erythema or discoloration 2 2 1
Loss or abnormal penile sensation 7 10 7
2.Primary Outcome
Title Adverse Events at 3 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Penile Traction Therapy Group 1x Daily x 3 Months Penile Traction Therapy Group 2x Daily x 3 Months Penile Traction Therapy Group 3x Daily x 3 Months
Hide Arm/Group Description:
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.
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.
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 Number of Participants Analyzed 27 28 27
Measure Type: Number
Unit of Measure: percentage of participants
Transient Erythema 43 41 37
Transient Sensory Changes 10 14 16
Transient Discomfort 33 50 37
3.Primary Outcome
Title Adverse Events at 6 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Period Penile Traction Therapy
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 63
Measure Type: Number
Unit of Measure: percentage of participants
Penile erythema or discoloration 35
Loss or abnormal penile sensation 5
New penile pain, Mild 27
4.Primary Outcome
Title Adverse Events at 9 Months
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Open Label Penile Traction Therapy
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: percentage of participants
Penile erythema or discoloration 4
New penile pain, Mild 4
5.Secondary Outcome
Title Change in Penile Length to Corona
Hide Description Stretched penile length measured in centimeters from pubic symphysis to glanular corona
Time Frame 3 months, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Control Group Penile Traction Therapy Group
Hide Arm/Group Description:
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.
RestoreX for 30 minutes (15 minutes straight and 15 minutes with counter bending) once, twice or 3 times daily as Penile Traction Therapy (PTT).
Overall Number of Participants Analyzed 27 62
Mean (Standard Deviation)
Unit of Measure: Centimeters
3 month Number Analyzed 27 participants 62 participants
0.3  (0.8) 1.3  (1.1)
6 month Number Analyzed 14 participants 37 participants
2.0  (1.1) 2.3  (2.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Penile Traction Therapy Group
Comments Control group vs Penile Traction Therapy Group at 3 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Penile Traction Therapy Group
Comments Control group vs Penile Traction Therapy Group at 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Change in Penile Length to Tip
Hide Description Stretched penile length measured in centimeters from pubic symphysis to penile tip
Time Frame 3 months, 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Control Group Penile Traction Therapy Group
Hide Arm/Group Description:
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.
RestoreX for 30 minutes (15 minutes straight and 15 minutes with counter bending) once, twice or 3 times daily as Penile Traction Therapy (PTT).
Overall Number of Participants Analyzed 27 62
Mean (Standard Deviation)
Unit of Measure: Centimeters
3 months Number Analyzed 27 participants 62 participants
0.0  (0.7) 1.5  (1.1)
6 months Number Analyzed 14 participants 37 participants
1.6  (1.2) 1.9  (1.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Penile Traction Therapy Group
Comments Control group vs Penile Traction Therapy Group at 3 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Penile Traction Therapy Group
Comments Control group vs. Penile Traction Therapy Group at 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Change in Penile Curvature
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Control Group Penile Traction Therapy Group
Hide Arm/Group Description:
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.
RestoreX for 30 minutes (15 minutes straight and 15 minutes with counter bending) once, twice or 3 times daily as Penile Traction Therapy (PTT).
Overall Number of Participants Analyzed 27 62
Mean (Standard Deviation)
Unit of Measure: degrees
3 months Number Analyzed 27 participants 62 participants
1.3  (19.0) -11.7  (15)
6 months Number Analyzed 14 participants 37 participants
-12.5  (18.6) -14.9  (18.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Penile Traction Therapy Group
Comments Control group vs Penile Traction Therapy Group at 3 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Penile Traction Therapy Group
Comments Control group vs. Penile Traction Therapy Group at 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Change Erectile Function
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Control Group Penile Traction Therapy Group
Hide Arm/Group Description:
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.
RestoreX for 30 minutes (15 minutes straight and 15 minutes with counter bending) once, twice or 3 times daily as Penile Traction Therapy (PTT).
Overall Number of Participants Analyzed 26 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
3 months Number Analyzed 26 participants 59 participants
-1.3  (6.7) 2.5  (6.3)
6 months Number Analyzed 14 participants 37 participants
1.8  (4.4) 4.4  (7.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Penile Traction Therapy Group
Comments Control group vs Penile Traction Therapy Group at 3 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control Group, Penile Traction Therapy Group
Comments Control group vs Penile Traction Therapy Group at 6 months
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.66
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Change in Peyronie's Disease Psychological and Physical Domain on Peyronie's Disease Questionnaire (PDQ)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
Arm/Group Title Control Group Penile Traction Therapy Group
Hide Arm/Group Description:
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.
RestoreX for 30 minutes (15 minutes straight and 15 minutes with counter bending) once, twice or 3 times daily as Penile Traction Therapy (PTT).
Overall Number of Participants Analyzed 23 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.6  (3.3) -2.3  (4.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Penile Traction Therapy Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Change in Peyronie's Disease Penile Pain Domain on Peyronie's Disease Questionnaire (PDQ)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
Arm/Group Title Control Group Penile Traction Therapy Group
Hide Arm/Group Description:
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.
RestoreX for 30 minutes (15 minutes straight and 15 minutes with counter bending) once, twice or 3 times daily as Penile Traction Therapy (PTT).
Overall Number of Participants Analyzed 23 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.8  (3.6) -1.4  (3.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Penile Traction Therapy Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.26
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
11.Secondary Outcome
Title Change in Peyronie's Disease Bother Domain of the Peyronie's Disease Questionnaire (PDQ)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
Arm/Group Title Control Group Penile Traction Therapy Group
Hide Arm/Group Description:
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.
RestoreX for 30 minutes (15 minutes straight and 15 minutes with counter bending) once, twice or 3 times daily as Penile Traction Therapy (PTT).
Overall Number of Participants Analyzed 23 59
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.9  (4.2) -2.4  (3.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group, Penile Traction Therapy Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Secondary Outcome
Title Overall Treatment Satisfaction
Hide Description Self reported satisfaction of penile traction therapy on a scale of very satisfied, somewhat satisfied, neutral, somewhat dissatisfied, very dissatisfied
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
Arm/Group Title Penile Traction Therapy Group
Hide Arm/Group Description:
RestoreX for 30 minutes (15 minutes straight and 15 minutes with counter bending) once, twice or 3 times daily as Penile Traction Therapy (PTT).
Overall Number of Participants Analyzed 63
Measure Type: Number
Unit of Measure: percentage of participants
% Very Satisfied 25.4
% Somewhat satisfied 41.3
% Neutral 30.2
% Somewhat dissatisfied 3.2
% Very dissatisfied 0
13.Secondary Outcome
Title Ability to Achieve Sexual Intercourse
Hide Description Change from no to yes on the self reported standardized sexual encounter profile questions 2 "able to penetrate"
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
Arm/Group Title Control Group Penile Traction Therapy Group
Hide Arm/Group Description:
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.
RestoreX for 30 minutes (15 minutes straight and 15 minutes with counter bending) once, twice or 3 times daily as Penile Traction Therapy (PTT).
Overall Number of Participants Analyzed 24 48
Measure Type: Number
Unit of Measure: percentage of participants
0 4
14.Secondary Outcome
Title Satisfaction With the RestoreX® Device to Alternative Forms of PTT
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
Arm/Group Title Penile Traction Therapy Group
Hide Arm/Group Description:
RestoreX for 30 minutes (15 minutes straight and 15 minutes with counter bending) once, twice or 3 times daily as Penile Traction Therapy (PTT).
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: percentage of participants
% RestoreX is much better 86.7
% RestoreX is somewhat better 13.3
% Both are equal 0
% RestoreX is somewhat worse 0
% RestoreX is much worse 0
15.Secondary Outcome
Title Satisfaction With the RestoreX® Device to Alternative PD Therapies
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
Arm/Group Title Penile Traction Therapy Group
Hide Arm/Group Description:
RestoreX for 30 minutes (15 minutes straight and 15 minutes with counter bending) once, twice or 3 times daily as Penile Traction Therapy (PTT).
Overall Number of Participants Analyzed 54
Measure Type: Number
Unit of Measure: percentage of participants
RestoreX 74.1
Collagenase clostridium histolyticum 23.6
Oral pills 14.8
Vacuum erection device 5.6
Surgery 1.8
Other therapy 1.8
Other traction device 0
16.Secondary Outcome
Title Ability to Achieve Sexual Intercourse
Hide Description Change from no to yes on the self reported standardized sexual encounter profile questions 2 "able to penetrate"
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
It was pre-specified to combine Penile Traction Therapy Groups for this analysis.
Arm/Group Title Control Group Penile Traction Therapy Group
Hide Arm/Group Description:
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.
RestoreX for 30 minutes (15 minutes straight and 15 minutes with counter bending) once, twice or 3 times daily as Penile Traction Therapy (PTT).
Overall Number of Participants Analyzed 14 37
Measure Type: Number
Unit of Measure: percentage of participants
0 4
Time Frame Adverse events were collected over a 9 month period for each subject receiving penile traction therapy.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Penile Traction Therapy Group 1x Daily x 3 Months Penile Traction Therapy Group 2x Daily x 3 Months Penile Traction Therapy Group 3x Daily x 3 Months Open Label Period Penile Traction Therapy
Hide Arm/Group Description 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. 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. 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. 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.
All-Cause Mortality
Penile Traction Therapy Group 1x Daily x 3 Months Penile Traction Therapy Group 2x Daily x 3 Months Penile Traction Therapy Group 3x Daily x 3 Months Open Label Period Penile Traction Therapy
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)      0/28 (0.00%)      0/27 (0.00%)      0/63 (0.00%)    
Hide Serious Adverse Events
Penile Traction Therapy Group 1x Daily x 3 Months Penile Traction Therapy Group 2x Daily x 3 Months Penile Traction Therapy Group 3x Daily x 3 Months Open Label Period Penile Traction Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      0/28 (0.00%)      0/27 (0.00%)      0/63 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Penile Traction Therapy Group 1x Daily x 3 Months Penile Traction Therapy Group 2x Daily x 3 Months Penile Traction Therapy Group 3x Daily x 3 Months Open Label Period Penile Traction Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/27 (59.26%)      15/28 (53.57%)      13/27 (48.15%)      28/63 (44.44%)    
Reproductive system and breast disorders         
Penile erythema or discoloration, transient  [1]  12/27 (44.44%)  12 12/28 (42.86%)  12 10/27 (37.04%)  10 24/63 (38.10%)  24
Loss or abnormal penile sensation, transient (new onset for 6-, 9-month cohorts)  [2]  3/27 (11.11%)  3 4/28 (14.29%)  4 4/27 (14.81%)  4 3/63 (4.76%)  3
New penile pain, transient (mild)  [3]  9/27 (33.33%)  9 14/28 (50.00%)  14 10/27 (37.04%)  10 19/63 (30.16%)  19
Indicates events were collected by systematic assessment
[1]
3 month outcomes among men in PTT group
[2]
Total includes men who either had symptom at 6 or 9 months
[3]
At 3 month time point (among men treated with traction)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Landon Trost
Organization: Mayo Clinic
Phone: 507-284-3728
EMail: Trost.Landon@mayo.edu
Layout table for additonal information
Responsible Party: Landon W. Trost, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03389854    
Other Study ID Numbers: 17-001283
First Submitted: October 19, 2017
First Posted: January 4, 2018
Results First Submitted: April 23, 2020
Results First Posted: August 12, 2020
Last Update Posted: August 12, 2020