Penile Diseases, Prostate Cancer
Conditions
Brief summary
The objective of the current study is to evaluate the efficacy of a novel, class I (ie. lowest risk, clinical studies not required) medical penile traction device in preventing loss of penile length in men undergoing robotic-assisted prostatectomy.
Detailed description
The treatment of prostate cancer results in several known sexual dysfunctions, including erectile dysfunction, orgasmic dysfunction, ejaculatory dysfunction, penile curvature (Peyronie's disease), and reduced penile length. Among the dysfunctions, loss of penile length is often one that results in significant distress and bother to patients. Beyond the esthetic concerns, reduced penile length may lead to inability to participate in sexual intercourse, difficulty with future interventions to restore erectile function, and lead to worsened urinary hygiene. Penile traction therapy (PTT) is currently the best available treatment to maintain or restore lost penile length due to conditions that reduce length. To date, no studies have evaluated the benefits of using PTT in this clinical setting. The objective of the current study is to evaluate the efficacy of a novel penile traction device (RestoreX®), created and funded through Mayo Ventures, in maintaining or restoring reduced penile length. To accomplish the study, a population of men from Mayo Clinic who have undergone a prostatectomy will be enrolled and randomized to utilize the device for varying amounts of time. Outcomes will be assessed at 6 and 9 months post-prostatectomy and results are to be used with the intent to publish in a scientific journal.
Interventions
DEVICERestoreX
PTT - Penile traction therapy in the straight position.
OTHERNo treatment
Control group. No treatment will be given for the 6 months post-prostatectomy
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Undergoing robotic prostatectomy * Seen in the post-prostatectomy rehab clinic
Exclusion criteria
• Urethral complications from prostatectomy at the time of baseline visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Penile Length | Baseline, 6 months | Stretched penile length measured in centimeters from pubic symphysis to glanular corona |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Erectogenic Therapy Use | 6 months | The percentage of subjects to use a phosphodiesterase-5 inhibitor for erectogenic therapy use |
| Intracavernosal Injections | 6 months | The percentage of subjects to use intracavernosal injections |
| Change in Erectile Function Domain of International Index of Erectile Function (IIEF) | baseline, 6 months | 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. |
| Change in Intercourse Satisfaction Domain of International Index of Erectile Function (IIEF) | Baseline, 6 months | 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. |
| Change in Overall Satisfaction Domain of International Index of Erectile Function (IIEF) | Baseline, 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 27 |
| 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. | 55 |
| Total | 82 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 25 |
Baseline characteristics
| Characteristic | Control | Total | PTT 1-2x Daily x 5-7 Days/Week x 5 Months |
|---|---|---|---|
| Age, Continuous | 58.2 years STANDARD_DEVIATION 4.5 | 58.6 years STANDARD_DEVIATION 6.1 | 58.7 years STANDARD_DEVIATION 6.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) White | 25 Participants | 73 Participants | 48 Participants |
| Region of Enrollment United States | 27 participants | 82 participants | 55 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 27 Participants | 82 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 55 |
| other Total, other adverse events | 0 / 27 | 17 / 55 |
| serious Total, serious adverse events | 0 / 27 | 0 / 55 |
Outcome results
Primary
Change in Penile Length
Stretched penile length measured in centimeters from pubic symphysis to glanular corona
Time frame: Baseline, 6 months
Population: 6 months data was not collected nor analyzed for 2 subjects in control arm and 25 subjects in PTT arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | Change in Penile Length | 0.3 centimeters | Standard Deviation 1.5 |
| PTT 1-2x Daily x 5-7 Days/Week x 5 Months | Change in Penile Length | 1.6 centimeters | Standard Deviation 1 |
Secondary
Change in Erectile Function Domain of International Index of Erectile Function (IIEF)
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.
Time frame: baseline, 6 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Change in Erectile Function Domain of International Index of Erectile Function (IIEF) | -6.5 units on a scale |
| PTT 1-2x Daily x 5-7 Days/Week x 5 Months | Change in Erectile Function Domain of International Index of Erectile Function (IIEF) | 0 units on a scale |
Secondary
Change in Intercourse Satisfaction Domain of International Index of Erectile Function (IIEF)
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.
Time frame: Baseline, 6 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Change in Intercourse Satisfaction Domain of International Index of Erectile Function (IIEF) | -3.5 units on a scale |
| PTT 1-2x Daily x 5-7 Days/Week x 5 Months | Change in Intercourse Satisfaction Domain of International Index of Erectile Function (IIEF) | 1 units on a scale |
Secondary
Change in Overall Satisfaction Domain of International Index of Erectile Function (IIEF)
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.
Time frame: Baseline, 6 months
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Change in Overall Satisfaction Domain of International Index of Erectile Function (IIEF) | -3 units on a scale |
| PTT 1-2x Daily x 5-7 Days/Week x 5 Months | Change in Overall Satisfaction Domain of International Index of Erectile Function (IIEF) | 0 units on a scale |
Secondary
Erectogenic Therapy Use
The percentage of subjects to use a phosphodiesterase-5 inhibitor for erectogenic therapy use
Time frame: 6 months
Population: 6 months data was not collected nor analyzed for 2 subjects in control arm and 25 subjects in PTT arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Erectogenic Therapy Use | 94 percentage of subjects |
| PTT 1-2x Daily x 5-7 Days/Week x 5 Months | Erectogenic Therapy Use | 86 percentage of subjects |
Secondary
Intracavernosal Injections
The percentage of subjects to use intracavernosal injections
Time frame: 6 months
Population: 6 months data was not collected nor analyzed for 2 subjects in control arm and 25 subjects in PTT arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Intracavernosal Injections | 50 percentage of subjects |
| PTT 1-2x Daily x 5-7 Days/Week x 5 Months | Intracavernosal Injections | 19 percentage of subjects |