Prostate Cancer Clinical Trial
Official title:
Penile Length Maintenance Post-Prostatectomy
Verified date | September 2021 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 82 |
Est. completion date | December 28, 2020 |
Est. primary completion date | December 28, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Undergoing robotic prostatectomy - Seen in the post-prostatectomy rehab clinic Exclusion Criteria: • Urethral complications from prostatectomy at the time of baseline visit |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Penile Length | Stretched penile length measured in centimeters from pubic symphysis to glanular corona | Baseline, 6 months | |
Secondary | Erectogenic Therapy Use | The percentage of subjects to use a phosphodiesterase-5 inhibitor for erectogenic therapy use | 6 months | |
Secondary | Intracavernosal Injections | The percentage of subjects to use intracavernosal injections | 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. | 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. | 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. | Baseline, 6 months |
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