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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03500419
Other study ID # 18-001013
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 23, 2018
Est. completion date December 28, 2020

Study information

Verified date September 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
RestoreX
PTT - Penile traction therapy in the straight position.
Other:
No treatment
Control group. No treatment will be given for the 6 months post-prostatectomy

Locations

Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

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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