Trial Outcomes & Findings for Penile Length Restoration in Men With Diabetes Mellitus, Type II (NCT NCT03756688)
NCT ID: NCT03756688
Last Updated: 2023-02-21
Results Overview
Primary objective of this study is to assess penile length pre and post completion of RestoreX traction therapy compared to control groups (no treatment) of Diabetes Type II patients. Measurements were obtained at baseline and 6 months post-prostatectomy.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
Baseline to 6 months
Results posted on
2023-02-21
Participant Flow
Participant milestones
| Measure |
Group 1: Control
No treatment will be administered for the entirety of the study (6 months)
|
Group 2: Treatment
PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)
|
Group 3: Treatment
PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
Group 4: Treatment
PTT for 30 min 2x day x 6 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
27
|
27
|
|
Overall Study
COMPLETED
|
26
|
17
|
19
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
11
|
8
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1: Control
n=28 Participants
No treatment will be administered for the entirety of the study (6 months)
|
Group 2: Treatment
n=28 Participants
PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)
|
Group 3: Treatment
n=27 Participants
PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
Group 4: Treatment
n=27 Participants
PTT for 30 min 2x day x 6 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 7.0 • n=28 Participants
|
55.1 years
STANDARD_DEVIATION 5.3 • n=28 Participants
|
55.0 years
STANDARD_DEVIATION 6.3 • n=27 Participants
|
56.2 years
STANDARD_DEVIATION 5.4 • n=27 Participants
|
54.9 years
STANDARD_DEVIATION 6.1 • n=110 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=28 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=110 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=28 Participants
|
28 Participants
n=28 Participants
|
27 Participants
n=27 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.
|
PRIMARY outcome
Timeframe: Baseline to 6 monthsPrimary objective of this study is to assess penile length pre and post completion of RestoreX traction therapy compared to control groups (no treatment) of Diabetes Type II patients. Measurements were obtained at baseline and 6 months post-prostatectomy.
Outcome measures
| Measure |
Group 1: Control
n=23 Participants
No treatment will be administered for the entirety of the study (6 months)
|
Group 2: Treatment
n=17 Participants
PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)
|
Group 3: Treatment
n=18 Participants
PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
Group 4: Treatment
n=17 Participants
PTT for 30 min 2x day x 6 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
|---|---|---|---|---|
|
Penile Length Change Between Baseline and Month 6
|
0 Median change from baseline (cm)
Interval -0.5 to 0.5
|
0.5 Median change from baseline (cm)
Interval -0.3 to 0.9
|
0.5 Median change from baseline (cm)
Interval 0.0 to 1.5
|
0.8 Median change from baseline (cm)
Interval 0.0 to 1.5
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: No patients were analyzed in the control arm since the outcome measure was assessing compliance with traction therapy (not administered to controls).
Records of use from daily journals
Outcome measures
| Measure |
Group 1: Control
No treatment will be administered for the entirety of the study (6 months)
|
Group 2: Treatment
n=17 Participants
PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)
|
Group 3: Treatment
n=17 Participants
PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
Group 4: Treatment
n=21 Participants
PTT for 30 min 2x day x 6 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
|---|---|---|---|---|
|
Patient Compliance With Traction Therapy
|
—
|
93.5 Percent compliance
Standard Deviation 9.7
|
91.5 Percent compliance
Standard Deviation 14.3
|
85.2 Percent compliance
Standard Deviation 21.1
|
SECONDARY outcome
Timeframe: 6 monthsLikert scale used to assess self-reported overall satisfaction; 1-10 (10 = maximum satisfaction); higher values signify a better outcome. Satisfaction was assessed at 6 months post-prostatectomy.
Outcome measures
| Measure |
Group 1: Control
n=16 Participants
No treatment will be administered for the entirety of the study (6 months)
|
Group 2: Treatment
n=18 Participants
PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)
|
Group 3: Treatment
n=20 Participants
PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
Group 4: Treatment
PTT for 30 min 2x day x 6 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
|---|---|---|---|---|
|
Patient Reported Satisfaction With Traction Therapy at 6 Months.
|
7.5 score on a scale
Interval 4.3 to 9.0
|
8 score on a scale
Interval 6.0 to 9.0
|
8 score on a scale
Interval 6.3 to 8.8
|
—
|
SECONDARY outcome
Timeframe: 3 and 6 months post-prostatectomyAdverse events were assessed at 3- and 6-months post-prostatectomy, with results summed and reported as a total.
Outcome measures
| Measure |
Group 1: Control
n=17 Participants
No treatment will be administered for the entirety of the study (6 months)
|
Group 2: Treatment
n=18 Participants
PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)
|
Group 3: Treatment
n=20 Participants
PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
Group 4: Treatment
PTT for 30 min 2x day x 6 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events With Use of RestoreX
Temporary penile pain (mild)
|
2 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Number of Participants With Adverse Events With Use of RestoreX
Pain in other location (unclear if related)
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Adverse Events With Use of RestoreX
Temporary erythema / discoloration (mild)
|
1 Participants
|
1 Participants
|
4 Participants
|
—
|
|
Number of Participants With Adverse Events With Use of RestoreX
Temporary decreased sensation (mild)
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Adverse Events With Use of RestoreX
Other (unclear if related)
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Number of Participants With Adverse Events With Use of RestoreX
Temporary bleeding from tape (mild)
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Note that reported events represent subjective reporting of penile curvature.
Subjective question to determine if the patient has developed any new penile curvature, indentation, deformity, or other findings consistent with Peyronie's Disease during the study period
Outcome measures
| Measure |
Group 1: Control
n=23 Participants
No treatment will be administered for the entirety of the study (6 months)
|
Group 2: Treatment
n=16 Participants
PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)
|
Group 3: Treatment
n=18 Participants
PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
Group 4: Treatment
n=22 Participants
PTT for 30 min 2x day x 6 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
|---|---|---|---|---|
|
Number of Participants With De-novo Peyronie's Disease Development
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 monthsSubjective questions on patient perceived improvement in length (yes/no, qualitative \[large, medium, small, none\]); note that some groups add to \>100% due to the effects of rounding.
Outcome measures
| Measure |
Group 1: Control
n=17 Participants
No treatment will be administered for the entirety of the study (6 months)
|
Group 2: Treatment
n=14 Participants
PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)
|
Group 3: Treatment
n=16 Participants
PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
Group 4: Treatment
n=20 Participants
PTT for 30 min 2x day x 6 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
|---|---|---|---|---|
|
Subjective Comparison of Changes in Penile Length
Subjective improvement in length (% yes)
|
0 Percentage of participants
|
36 Percentage of participants
|
63 Percentage of participants
|
65 Percentage of participants
|
|
Subjective Comparison of Changes in Penile Length
Subjective improvement in length (% unsure)
|
0 Percentage of participants
|
36 Percentage of participants
|
25 Percentage of participants
|
25 Percentage of participants
|
|
Subjective Comparison of Changes in Penile Length
Subjective improvement in length (no)
|
100 Percentage of participants
|
29 Percentage of participants
|
13 Percentage of participants
|
10 Percentage of participants
|
|
Subjective Comparison of Changes in Penile Length
Subjective improvement (large)
|
0 Percentage of participants
|
0 Percentage of participants
|
9 Percentage of participants
|
13 Percentage of participants
|
|
Subjective Comparison of Changes in Penile Length
Subjective improvement (medium)
|
0 Percentage of participants
|
50 Percentage of participants
|
9 Percentage of participants
|
44 Percentage of participants
|
|
Subjective Comparison of Changes in Penile Length
Subjective improvement (small)
|
0 Percentage of participants
|
50 Percentage of participants
|
82 Percentage of participants
|
38 Percentage of participants
|
|
Subjective Comparison of Changes in Penile Length
Subjective improvement (none)
|
100 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
6 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 6 monthsStandardized questionnaire assessment of erectile function (International Index of Erectile Function standardized questionnaire, Erectile Function Domain \[questions 1-5 and 15\]). Higher scores are better. Assessments were obtained at baseline and at 6 months post-prostatectomy with the result reported being 6 months minus baseline. Minimum score for the change since baseline = -29 (i.e. 1 minus 30), maximum score = 29 (i.e. 30 minus 1)
Outcome measures
| Measure |
Group 1: Control
n=25 Participants
No treatment will be administered for the entirety of the study (6 months)
|
Group 2: Treatment
n=17 Participants
PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)
|
Group 3: Treatment
n=17 Participants
PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
Group 4: Treatment
n=20 Participants
PTT for 30 min 2x day x 6 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
|---|---|---|---|---|
|
Erectile Function Among Groups - Evaluating Change From Baseline to 6 Months.
|
0 score on a scale
Standard Deviation 3.3
|
1.1 score on a scale
Standard Deviation 4.6
|
4.2 score on a scale
Standard Deviation 10.4
|
4.3 score on a scale
Standard Deviation 9.3
|
Adverse Events
Group 2: Treatment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 3: Treatment
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 4: Treatment
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 2: Treatment
n=28 participants at risk
PTT for 30 min 2x/ day x 3 months, followed by no treatment x 3 months
RestoreX PTT - 3 months: Penile traction therapy in straight position for first phase (3 months)
|
Group 3: Treatment
n=27 participants at risk
PTT for 30 min 2x/day x 3 months, followed by once weekly (30 minutes) x 3 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
Group 4: Treatment
n=27 participants at risk
PTT for 30 min 2x day x 6 months
RestoreX PTT - 6 months: Penile traction therapy in straight position for all 6 months.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Transient penile pain
|
7.1%
2/28 • Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.
The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.
|
7.4%
2/27 • Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.
The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.
|
7.4%
2/27 • Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.
The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.
|
|
Skin and subcutaneous tissue disorders
Transient penile erythema
|
3.6%
1/28 • Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.
The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.
|
3.7%
1/27 • Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.
The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.
|
14.8%
4/27 • Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.
The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.
|
|
Skin and subcutaneous tissue disorders
Other pain (non-descript location)
|
3.6%
1/28 • Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.
The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.
|
0.00%
0/27 • Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.
The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.
|
3.7%
1/27 • Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.
The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.
|
|
Skin and subcutaneous tissue disorders
Transient decreased penile sensation
|
0.00%
0/28 • Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.
The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.
|
0.00%
0/27 • Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.
The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.
|
3.7%
1/27 • Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.
The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.
|
|
Skin and subcutaneous tissue disorders
Temporary bleeding
|
0.00%
0/28 • Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.
The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.
|
0.00%
0/27 • Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.
The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.
|
3.7%
1/27 • Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.
The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.
|
|
Skin and subcutaneous tissue disorders
Other (unclear if related)
|
0.00%
0/28 • Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.
The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.
|
0.00%
0/27 • Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.
The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.
|
3.7%
1/27 • Adverse events were collected over a 6 month period for each subject receiving penile traction treatment.
The control group (Group 1) did not receive penile traction treatment with the traction device. Therefore, adverse events were not collected for this group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place