Trial Outcomes & Findings for Penile Length Maintenance Post-Prostatectomy (NCT NCT03500419)
NCT ID: NCT03500419
Last Updated: 2021-10-20
Results Overview
Stretched penile length measured in centimeters from pubic symphysis to glanular corona
COMPLETED
NA
82 participants
Baseline, 6 months
2021-10-20
Participant Flow
Participant milestones
| Measure |
Control
No treatment was administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes.
No treatment: Control group. No treatment was given for the 6 months post-prostatectomy
|
PTT 1-2x Daily x 5-7 Days/Week x 5 Months
Men utilized penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy for a period of 5 months.
RestoreX: PTT - Penile traction therapy in the straight position.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
55
|
|
Overall Study
COMPLETED
|
25
|
30
|
|
Overall Study
NOT COMPLETED
|
2
|
25
|
Reasons for withdrawal
| Measure |
Control
No treatment was administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes.
No treatment: Control group. No treatment was given for the 6 months post-prostatectomy
|
PTT 1-2x Daily x 5-7 Days/Week x 5 Months
Men utilized penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy for a period of 5 months.
RestoreX: PTT - Penile traction therapy in the straight position.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
25
|
Baseline Characteristics
Penile Length Maintenance Post-Prostatectomy
Baseline characteristics by cohort
| Measure |
Control
n=27 Participants
No treatment was administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes.
No treatment: Control group. No treatment was given for the 6 months post-prostatectomy
|
PTT 1-2x Daily x 5-7 Days/Week x 5 Months
n=55 Participants
Men utilized penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy for a period of 5 months.
RestoreX: PTT - Penile traction therapy in the straight position.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.2 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
58.7 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
58.6 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
55 participants
n=7 Participants
|
82 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsPopulation: 6 months data was not collected nor analyzed for 2 subjects in control arm and 25 subjects in PTT arm.
Stretched penile length measured in centimeters from pubic symphysis to glanular corona
Outcome measures
| Measure |
Control
n=25 Participants
No treatment was administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes.
No treatment: Control group. No treatment was given for the 6 months post-prostatectomy
|
PTT 1-2x Daily x 5-7 Days/Week x 5 Months
n=30 Participants
Men utilized penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy for a period of 5 months.
RestoreX: PTT - Penile traction therapy in the straight position.
|
|---|---|---|
|
Change in Penile Length
|
0.3 centimeters
Standard Deviation 1.5
|
1.6 centimeters
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 6 months data was not collected nor analyzed for 2 subjects in control arm and 25 subjects in PTT arm.
The percentage of subjects to use a phosphodiesterase-5 inhibitor for erectogenic therapy use
Outcome measures
| Measure |
Control
n=25 Participants
No treatment was administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes.
No treatment: Control group. No treatment was given for the 6 months post-prostatectomy
|
PTT 1-2x Daily x 5-7 Days/Week x 5 Months
n=30 Participants
Men utilized penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy for a period of 5 months.
RestoreX: PTT - Penile traction therapy in the straight position.
|
|---|---|---|
|
Erectogenic Therapy Use
|
94 percentage of subjects
|
86 percentage of subjects
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: 6 months data was not collected nor analyzed for 2 subjects in control arm and 25 subjects in PTT arm.
The percentage of subjects to use intracavernosal injections
Outcome measures
| Measure |
Control
n=25 Participants
No treatment was administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes.
No treatment: Control group. No treatment was given for the 6 months post-prostatectomy
|
PTT 1-2x Daily x 5-7 Days/Week x 5 Months
n=30 Participants
Men utilized penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy for a period of 5 months.
RestoreX: PTT - Penile traction therapy in the straight position.
|
|---|---|---|
|
Intracavernosal Injections
|
50 percentage of subjects
|
19 percentage of subjects
|
SECONDARY outcome
Timeframe: baseline, 6 monthsPopulation: 6 months data was not collected nor analyzed for 2 subjects in control arm and 25 subjects in PTT arm. Negative denotes loss of function.
Erectile function domain will be measured by using the International Index of Erectile Function (IIEF) questionnaire. IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.
Outcome measures
| Measure |
Control
n=25 Participants
No treatment was administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes.
No treatment: Control group. No treatment was given for the 6 months post-prostatectomy
|
PTT 1-2x Daily x 5-7 Days/Week x 5 Months
n=30 Participants
Men utilized penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy for a period of 5 months.
RestoreX: PTT - Penile traction therapy in the straight position.
|
|---|---|---|
|
Change in Erectile Function Domain of International Index of Erectile Function (IIEF)
|
-6.5 units on a scale
Interval -21.5 to -2.0
|
0 units on a scale
Interval -7.5 to 4.0
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 6 months data was not collected nor analyzed for 2 subjects in control arm and 25 subjects in PTT arm. Negative denotes loss of function.
Intercourse satisfaction will be measured by using the International Index of Erectile Function (IIEF) questionnaire. IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.
Outcome measures
| Measure |
Control
n=25 Participants
No treatment was administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes.
No treatment: Control group. No treatment was given for the 6 months post-prostatectomy
|
PTT 1-2x Daily x 5-7 Days/Week x 5 Months
n=30 Participants
Men utilized penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy for a period of 5 months.
RestoreX: PTT - Penile traction therapy in the straight position.
|
|---|---|---|
|
Change in Intercourse Satisfaction Domain of International Index of Erectile Function (IIEF)
|
-3.5 units on a scale
Interval -7.0 to 0.0
|
1 units on a scale
Interval -2.0 to 7.0
|
SECONDARY outcome
Timeframe: Baseline, 6 monthsPopulation: 6 months data was not collected nor analyzed for 2 subjects in control arm and 25 subjects in PTT arm. Negative denotes loss of function.
Overall satisfaction domain will be measured by using the International Index of Erectile Function (IIEF) questionnaire. IIEF is a validated, 15-item questionnaire that assesses 5 domains of sexual function: erectile function (range 1-30), orgasmic function (range 0-10), sexual desire (range 2-10), intercourse satisfaction (range 0-15), and overall sexual satisfaction (range 2-10). Each question was answered on a 6-point or 5-point scale from 0/1 to 5 (best) with a total possible score (sum of 5 domains) range of 5 to 75 with higher scores representing better function.
Outcome measures
| Measure |
Control
n=25 Participants
No treatment was administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes.
No treatment: Control group. No treatment was given for the 6 months post-prostatectomy
|
PTT 1-2x Daily x 5-7 Days/Week x 5 Months
n=30 Participants
Men utilized penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy for a period of 5 months.
RestoreX: PTT - Penile traction therapy in the straight position.
|
|---|---|---|
|
Change in Overall Satisfaction Domain of International Index of Erectile Function (IIEF)
|
-3 units on a scale
Interval -6.0 to -1.0
|
0 units on a scale
Interval -2.8 to 0.8
|
Adverse Events
Control
PTT 1-2x Daily x 5-7 Days/Week x 5 Months
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control
n=27 participants at risk
No treatment was administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes.
No treatment: Control group. No treatment was given for the 6 months post-prostatectomy
|
PTT 1-2x Daily x 5-7 Days/Week x 5 Months
n=55 participants at risk
Men utilized penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy for a period of 5 months.
RestoreX: PTT - Penile traction therapy in the straight position.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Temporary penile erythema or discoloration
|
0.00%
0/27 • Adverse events were collected from baseline until end of intervention, approximately 6 months.
|
10.9%
6/55 • Number of events 6 • Adverse events were collected from baseline until end of intervention, approximately 6 months.
|
|
General disorders
Temporary mile penile discomfort
|
0.00%
0/27 • Adverse events were collected from baseline until end of intervention, approximately 6 months.
|
20.0%
11/55 • Number of events 11 • Adverse events were collected from baseline until end of intervention, approximately 6 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place