NCT03500419 · REGISTRY CONDITION SEARCH

Penile Length Maintenance Post-Prostatectomy

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: NA
Status at capture: COMPLETED
Registry last update: 2021-10-20

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Change in Penile Length

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outcome · POSTED

Erectogenic Therapy Use

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outcome · POSTED

Intracavernosal Injections

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outcome · POSTED

Change in Erectile Function Domain of International Index of Erectile Function (IIEF)

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outcome · POSTED

Change in Intercourse Satisfaction Domain of International Index of Erectile Function (IIEF)

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outcome · POSTED

Change in Overall Satisfaction Domain of International Index of Erectile Function (IIEF)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Undergoing robotic prostatectomy * Seen in the post-prostatectomy rehab clinic Exclusion Criteria: • Urethral complications from prostatectomy at the time of baseline visit
healthy Volunteers: false
minimum Age: 18 Years
sex: MALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Other: No treatment
label
Control
type
ACTIVE_COMPARATOR
description
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.
intervention Names
Device: RestoreX
label
Group AB - PTT 1-2x daily x 5-7 days/week x 5 months
type
EXPERIMENTAL

interventions

arm Group Labels
Group AB - PTT 1-2x daily x 5-7 days/week x 5 months
description
PTT - Penile traction therapy in the straight position.
name
RestoreX
type
DEVICE
arm Group Labels
Control
description
Control group. No treatment will be given for the 6 months post-prostatectomy
name
No treatment
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: DOUBLE
who Masked: INVESTIGATOR
OUTCOMES_ASSESSOR

primary Purpose

TREATMENT

Enrollment

count: 82
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Stretched penile length measured in centimeters from pubic symphysis to glanular corona
measure
Change in Penile Length
time Frame
Baseline, 6 months

secondary Outcomes

description
The percentage of subjects to use a phosphodiesterase-5 inhibitor for erectogenic therapy use
measure
Erectogenic Therapy Use
time Frame
6 months
description
The percentage of subjects to use intracavernosal injections
measure
Intracavernosal Injections
time Frame
6 months
description
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.
measure
Change in Erectile Function Domain of International Index of Erectile Function (IIEF)
time Frame
baseline, 6 months
description
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.
measure
Change in Intercourse Satisfaction Domain of International Index of Erectile Function (IIEF)
time Frame
Baseline, 6 months
description
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.
measure
Change in Overall Satisfaction Domain of International Index of Erectile Function (IIEF)
time Frame
Baseline, 6 months

Full study description

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.

Source references