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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | No treatment will be administered for the initial 6 months post-prostatectomy. This is necessary as a measure to review post-prostatectomy penile length changes. |
|
| Group AB - PTT 1-2x daily x 5-7 days/week x 5 months | Experimental | Men will utilize penile traction therapy for 30 minutes 1-2 times daily, 5-7 times a week, beginning 4 weeks post-prostatectomy. Men will remain in this phase for a period of 5 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RestoreX | Device | PTT - Penile traction therapy in the straight position. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Penile Length | Stretched penile length measured in centimeters from pubic symphysis to glanular corona | Baseline, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Erectogenic Therapy Use | The percentage of subjects to use a phosphodiesterase-5 inhibitor for erectogenic therapy use | 6 months |
| Intracavernosal Injections | The percentage of subjects to use intracavernosal injections |
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Inclusion Criteria:
Exclusion Criteria:
• Urethral complications from prostatectomy at the time of baseline visit
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Ziegelmann, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | PTT 1-2x Daily x 5-7 Days/Week x 5 Months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Penile Length | Stretched penile length measured in centimeters from pubic symphysis to glanular corona | 6 months data was not collected nor analyzed for 2 subjects in control arm and 25 subjects in PTT arm. | Posted | Mean | Standard Deviation | centimeters | Baseline, 6 months |
|
Adverse events were collected from baseline until end of intervention, approximately 6 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Temporary penile erythema or discoloration | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew (Matt) J. Ziegelmann, M.D. | Mayo Clinic | 507-266-3982 | Ziegelmann.Matthew@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 3, 2019 | Nov 6, 2019 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D010409 | Penile Diseases |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| No treatment | Other | Control group. No treatment will be given for the 6 months post-prostatectomy |
|
| 6 months |
| 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. | baseline, 6 months |
| 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. | Baseline, 6 months |
| 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. | Baseline, 6 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Erectogenic Therapy Use | The percentage of subjects to use a phosphodiesterase-5 inhibitor for erectogenic therapy use | 6 months data was not collected nor analyzed for 2 subjects in control arm and 25 subjects in PTT arm. | Posted | Number | percentage of subjects | 6 months |
|
|
|
| Secondary | Intracavernosal Injections | The percentage of subjects to use intracavernosal injections | 6 months data was not collected nor analyzed for 2 subjects in control arm and 25 subjects in PTT arm. | Posted | Number | percentage of subjects | 6 months |
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | units on a scale | baseline, 6 months |
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 6 months |
|
|
|
| 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. | 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. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, 6 months |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | 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. | 0 | 55 | 0 | 55 | 17 | 55 |
| Temporary mile penile discomfort | General disorders | Systematic Assessment |
|
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |