Erectile Dysfunction Following Radical ProstatectomyNCT01718704
Viberect Penile Vibratory Stimulation to Enhance Recovery of Erectile Function and Urinary Continence Post-Prostatectomy
A study testing Viberect device in people with Erectile Dysfunction Following Radical Prostatectomy and Urinary Incontinence of Non-organic Origin, run by Johns Hopkins University at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate whether using penile vibratory stimulation with the Viberect handheld device can help the recovery of erections and urinary control after radical prostatectomy. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Erectile Dysfunction Following Radical Prostatectomy, Urinary Incontinence of Non-organic Origin
- What is being tested?
- Viberect device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2013to 27 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with biopsy proven low/moderate risk prostate cancer (Gleason 3+3=6, 3+4=7, 3+2=5, 2+3=5, cT1c, cT2a, cT2b, preoperative prostatic specific antigen (PSA) less than 10)
- between ages 40-70
- preoperative IIEF (erectile function domain) score equal or greater than 20
- IPSS less than 10 and no urinary incontinence
Who cannot join
- Men with neurological disease
- IIEF score less than 20
- high risk prostate cancer (Gleason 4+3=7, 4+4=8, any Gleason 5, cT2c, cT3, PSA > 10)
- spinal cord injury
- history of transurethral resection of prostate (TURP) or other prostate ablative procedures
- history of priapism, pelvic neuropathy, penile skin lesions/ulcers
- inability to understand and demonstrate device use instructions.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Frederick Urology Specialists
Frederick, Maryland, 21701
About this study
Official title: Study of Non-Invasive Viberect® Penile Vibratory Stimulation Regimen to Enhance Recovery of Erectile Function/Rigidity and Urinary Control/Continence After Nerve Sparing Radical Prostatectomy (RP) for Clinically Localized Prostate Cancer.
The purpose of this study is to evaluate whether using penile vibratory stimulation with the Viberect handheld device can help the recovery of erections and urinary control after radical prostatectomy.
Read the detailed description
Prostate cancer screening programs have led to thousands of sexually healthy and continent men being diagnosed with prostate cancer every year. Recent literature suggests that up to 80% of these cancers are confined to the prostate gland. Currently, radical prostatectomy (RP) remains the best option for management of clinically localized prostate cancer in men with life expectancy greater than 10 years. Despite providing optimal cancer control, surgery can lead to quality of life (QOL) problems such as urinary incontinence and erectile dysfunction (ED). Refinement of surgical technique have improved sexual and continence outcomes; however erectile function lags behind other QOL measures by 1-2 years, and quality of returning erections is often inferior. This can have profound biological, marital, and psychological consequences in potent men undergoing RP.
ED is the inability to develop and maintain an erection for satisfactory sexual intercourse or activity. ED after nerve-sparing RP is related to a certain degree with functional impairment of cavernous nerves (CN) that travel along the prostate to the penis. This neuropraxia can last as long as 2 years. Pro-erectile nerve stimulus is vital for replenishment of corporal oxygen supply and other metabolic needs. Several histological analyses have demonstrated decreased smooth muscle number, cell-cell contact, venous leakage, collagen deposition, and additional harmful effects to corporal tissue after injury to CN.
Awaiting post-surgical neuropraxia recovery, urologists have proposed a proactive approach to use of oral, intraurethral or injectable pharmacotherapy, neuromodulation, or vacuum-assisted regimens in erectile rehabilitation programs. Several studies demonstrate variable functional improvement in erectile function. Unfortunately, prohibitive costs of medications, poor response, and pain from injectables or intraurethral application often lead to high dropout rates.
In addition to ED, a significant proportion of men after surgery develop and suffer from urinary incontinence (Stress, Urge, Mixed) requiring wearing pads with bothersome complaints persisting for months, even years after RP.
The primary objective is to assess the role of penile vibratory stimulation by the Viberect device in enhancing the recovery of erectile function/rigidity and urinary continence after RP for clinically localized prostate cancer. The difference in penile length will be compared in each arm.
The secondary objective is to obtain a formal risk analysis (RA). Other objectives are to assess the ease of use and acceptability of vibratory stimulation at home.
- Conditions
- Erectile Dysfunction Following Radical Prostatectomy, Urinary Incontinence of Non-organic Origin
- Being tested
- Viberect device
- Keywords
- rehabilitation, erectile dysfunction, incontinence
- Medical subject headings
- Nocturnal Enuresis, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viberect deviceDevice
Men who begin using the Viberect device 3 days after Foley catheter removal on a daily (or at least 4 times a week) basis for 7-10 minutes in a relaxed setting with sexual thoughts or foreplay for one year. Viberect method can be performed by the person's sexual partner.
| Study group | Role | What they receive |
|---|---|---|
| Viberect device | Experimental | Men in this group will begin using the Viberect device 3 days after Foley catheter removal after surgery on a daily (or at least 4 times a week) basis for 7-10 minutes in a relaxed setting. Receives: Device: Viberect device |
| No Viberect | No intervention | Men in this group will not be provided with the Viberect device |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in erectile function
The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction
Measured: baseline to 6 weeks after first device use
change in erectile function
IIEF questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction
Measured: baseline to 3 months after first device use
change in erectile function
IIEF questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction
Measured: baseline to 6 months after first device use
change in erectile function
The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction
Measured: baseline to 9 months after first device use
change in erectile function
The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction
Measured: baseline to 12 months after first device use
change in erectile function
The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction
Measured: baseline to 6 weeks after first device use
change in erectile function
The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction
Measured: baseline to 3 months after first device use
change in erectile function
The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction
Measured: baseline to 6 months after first device use
change in erectile function
The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction
Measured: baseline to 9 months after first device use
change in erectile function
The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction
Measured: baseline to 12 months after first device use
change in erectile function
The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse
Measured: baseline to 6 weeks after first device use
change in erectile function
The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse
Measured: baseline to 3 months after first device use
change in erectile function
The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse
Measured: baseline to 6 months after first device use
change in erectile function (EF)
The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse
Measured: baseline to 9 months after first device use
change in EF
The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse
Measured: baseline to 12 months after first device use
change in EF
Measurement of penile length from corona to dorsal glans penis in centimeters
Measured: baseline to 6 weeks after first device use
change in EF
Measurement of penile length from corona to dorsal glans penis in centimeters
Measured: baseline to 3 months after first device use
change in EF
Measurement of penile length from corona to dorsal glans penis in centimeters
Measured: baseline to 6 months after first device use
change in EF
Measurement of penile length from corona to dorsal glans penis in centimeters
Measured: baseline to 9 months after first device use
change in EF
Measurement of penile length from corona to dorsal glans penis in centimeters
Measured: baseline to 12 months after first device use
Secondary outcomes (15)
change in urinary control
The Expanded Prostate Cancer Index Composite (EPIC) urinary function assessment questionnaire will be administered. This is a 7 item tool assessing urinary function over the past 4 weeks. Higher scores indicate decreased urinary control
Measured: baseline to 6 weeks after first device use
change in urinary control
The Expanded Prostate Cancer Index Composite (EPIC) urinary function assessment questionnaire will be administered. This is a 7 item tool assessing urinary function over the past 4 weeks. Higher scores indicate decreased urinary control
Measured: baseline to 3 months after first device use
change in urinary control
The Expanded Prostate Cancer Index Composite (EPIC) urinary function assessment questionnaire will be administered. This is a 7 item tool assessing urinary function over the past 4 weeks. Higher scores indicate decreased urinary control
Measured: baseline to 6 months after first device use
change in urinary control
The Expanded Prostate Cancer Index Composite (EPIC) urinary function assessment questionnaire will be administered. This is a 7 item tool assessing urinary function over the past 4 weeks. Higher scores indicate decreased urinary control
Measured: baseline to 9 months after first device use
change in urinary control
The Expanded Prostate Cancer Index Composite (EPIC) urinary function assessment questionnaire will be administered. This is a 7 item tool assessing urinary function over the past 4 weeks. Higher scores indicate decreased urinary control
Measured: baseline to 12 months after first device use
change in urinary control
Mass of incontinence guards used over a 24 hour period in grams
Measured: baseline to 6 weeks after first device use
change in urinary control
Mass of incontinence guards used over a 24 hour period in grams
Measured: baseline to 3 months after first device use
change in urinary control
Mass of incontinence guards used over a 24 hour period in grams
Measured: baseline to 6 months after first device use
change in urinary control
Mass of incontinence guards used over a 24 hour period in grams
Measured: baseline to 9 months after first device use
change in urinary control
Mass of incontinence guards used over a 24 hour period in grams
Measured: baseline to 12 months after first device use
change in urinary control
The International Prostate Symptom Score (IPSS) Questionnaire will be administered. 7 questionnaires address urinary control with a total attainable score from 0-35. 0 = no dysfunction, 1-7 = mild dysfunction, 8 - 19 = moderate dysfunction, 20-35 = severe dysfunction. The 8th/final item addresses impact of urinary control on quality of life
Measured: baseline to 6 weeks after first device use
change in urinary control
The International Prostate Symptom Score (IPSS) Questionnaire will be administered. 7 questionnaires address urinary control with a total attainable score from 0-35. 0 = no dysfunction, 1-7 = mild dysfunction, 8 - 19 = moderate dysfunction, 20-35 = severe dysfunction. The 8th/final item addresses impact of urinary control on quality of life
Measured: baseline to 3 months after first device use
change in urinary control
The International Prostate Symptom Score (IPSS) Questionnaire will be administered. 7 questionnaires address urinary control with a total attainable score from 0-35. 0 = no dysfunction, 1-7 = mild dysfunction, 8 - 19 = moderate dysfunction, 20-35 = severe dysfunction. The 8th/final item addresses impact of urinary control on quality of life
Measured: baseline to 6 months after first device use
change in urinary control
The International Prostate Symptom Score (IPSS) Questionnaire will be administered. 7 questionnaires address urinary control with a total attainable score from 0-35. 0 = no dysfunction, 1-7 = mild dysfunction, 8 - 19 = moderate dysfunction, 20-35 = severe dysfunction. The 8th/final item addresses impact of urinary control on quality of life
Measured: baseline to 9 months after first device use
change in urinary control
The International Prostate Symptom Score (IPSS) Questionnaire will be administered. 7 questionnaires address urinary control with a total attainable score from 0-35. 0 = no dysfunction, 1-7 = mild dysfunction, 8 - 19 = moderate dysfunction, 20-35 = severe dysfunction. The 8th/final item addresses impact of urinary control on quality of life
Measured: baseline to 12 months after first device use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startApr 2013
- Primary completion27 Mar 2019
- Study completion27 Mar 2019
Why it stopped: Study was stopped due to inability to accrue patients because of competing trials.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile Dysfunction Following Radical ProstatectomyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur L Burnett, MD, MBA, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718704
- Sponsor's protocol ID
- NA_00069795
- Status last verified
- May 2019
- First submitted
- 24 Oct 2012
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Non-Invasive Viberect® Penile Vibratory Stimulation Regimen to Enhance Recovery of Erectile Function/Rigidity and Urinary Control/Continence After Nerve Sparing Radical Prostatectomy (RP) for Clinically Localized Prostate Cancer.
- ClinicalTrials.gov ID
- NCT01718704
- Acronym / sponsor ID
- NA_00069795
- Conditions
- Erectile Dysfunction Following Radical Prostatectomy, Urinary Incontinence of Non-organic Origin
- Keywords
- rehabilitation, erectile dysfunction, incontinence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was stopped due to inability to accrue patients because of competing trials.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- 27 Mar 2019 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 31 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether using penile vibratory stimulation with the Viberect handheld device can help the recovery of erections and urinary control after radical prostatectomy.
Detailed description
Prostate cancer screening programs have led to thousands of sexually healthy and continent men being diagnosed with prostate cancer every year. Recent literature suggests that up to 80% of these cancers are confined to the prostate gland. Currently, radical prostatectomy (RP) remains the best option for management of clinically localized prostate cancer in men with life expectancy greater than 10 years. Despite providing optimal cancer control, surgery can lead to quality of life (QOL) problems such as urinary incontinence and erectile dysfunction (ED). Refinement of surgical technique have improved sexual and continence outcomes; however erectile function lags behind other QOL measures by 1-2 years, and quality of returning erections is often inferior. This can have profound biological, marital, and psychological consequences in potent men undergoing RP.
ED is the inability to develop and maintain an erection for satisfactory sexual intercourse or activity. ED after nerve-sparing RP is related to a certain degree with functional impairment of cavernous nerves (CN) that travel along the prostate to the penis. This neuropraxia can last as long as 2 years. Pro-erectile nerve stimulus is vital for replenishment of corporal oxygen supply and other metabolic needs. Several histological analyses have demonstrated decreased smooth muscle number, cell-cell contact, venous leakage, collagen deposition, and additional harmful effects to corporal tissue after injury to CN.
Awaiting post-surgical neuropraxia recovery, urologists have proposed a proactive approach to use of oral, intraurethral or injectable pharmacotherapy, neuromodulation, or vacuum-assisted regimens in erectile rehabilitation programs. Several studies demonstrate variable functional improvement in erectile function. Unfortunately, prohibitive costs of medications, poor response, and pain from injectables or intraurethral application often lead to high dropout rates.
In addition to ED, a significant proportion of men after surgery develop and suffer from urinary incontinence (Stress, Urge, Mixed) requiring wearing pads with bothersome complaints persisting for months, even years after RP.
The primary objective is to assess the role of penile vibratory stimulation by the Viberect device in enhancing the recovery of erectile function/rigidity and urinary continence after RP for clinically localized prostate cancer. The difference in penile length will be compared in each arm.
The secondary objective is to obtain a formal risk analysis (RA). Other objectives are to assess the ease of use and acceptability of vibratory stimulation at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Viberect device | Experimental | Device: Viberect deviceMen in this group will begin using the Viberect device 3 days after Foley catheter removal after surgery on a daily (or at least 4 times a week) basis for 7-10 minutes in a relaxed setting. |
| No Viberect | No intervention | –Men in this group will not be provided with the Viberect device |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with biopsy proven low/moderate risk prostate cancer (Gleason 3+3=6, 3+4=7, 3+2=5, 2+3=5, cT1c, cT2a, cT2b, preoperative prostatic specific antigen (PSA) less than 10)
- between ages 40-70
- preoperative IIEF (erectile function domain) score equal or greater than 20
- IPSS less than 10 and no urinary incontinence
Key exclusion criteria (7 listed)
- Men with neurological disease
- IIEF score less than 20
- high risk prostate cancer (Gleason 4+3=7, 4+4=8, any Gleason 5, cT2c, cT3, PSA > 10)
- spinal cord injury
- history of transurethral resection of prostate (TURP) or other prostate ablative procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viberect deviceMen who begin using the Viberect device 3 days after Foley catheter removal on a daily (or at least 4 times a week) basis for 7-10 minutes in a relaxed setting with sexual thoughts or foreplay for one year. Viberect method can be performed by the person's sexual partner. | Device | Viberect device |
Primary outcome
change in erectile function
Time frame: baseline to 6 weeks after first device use
The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction
change in erectile function
Time frame: baseline to 3 months after first device use
IIEF questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction
change in erectile function
Time frame: baseline to 6 months after first device use
IIEF questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction
change in erectile function
Time frame: baseline to 9 months after first device use
The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction
change in erectile function
Time frame: baseline to 12 months after first device use
The International Index for Erectile Function (IIEF) questionnaire will be administered. This is a 15 item tool; 6 ask questions addressing Erectile function over the previous 4 weeks. Scores from 0-30 can be obtained in this domain. Scores are interpreted as follows: 0-6 = Severe dysfunction, 7-12 = Moderate dysfunction, 13-18 = mild-moderate dysfunction, 19-24 = mild dysfunction, 25-30 = No dysfunction
change in erectile function
Time frame: baseline to 6 weeks after first device use
The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction
change in erectile function
Time frame: baseline to 3 months after first device use
The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction
change in erectile function
Time frame: baseline to 6 months after first device use
The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction
change in erectile function
Time frame: baseline to 9 months after first device use
The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction
change in erectile function
Time frame: baseline to 12 months after first device use
The Expanded Prostate Cancer Index Composite (EPIC) sexual assessment questionnaire will be administered. The tool has 9 questions about erectile function over the previous 4 weeks. It is scored from 9 - 43 with higher scores indicating greater dysfunction
change in erectile function
Time frame: baseline to 6 weeks after first device use
The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse
change in erectile function
Time frame: baseline to 3 months after first device use
The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse
change in erectile function
Time frame: baseline to 6 months after first device use
The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse
change in erectile function (EF)
Time frame: baseline to 9 months after first device use
The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse
change in EF
Time frame: baseline to 12 months after first device use
The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single item tool. It is scored from 1 to 4. 4 indicates attainment of full rigidity with ability to perform penetrative intercourse
change in EF
Time frame: baseline to 6 weeks after first device use
Measurement of penile length from corona to dorsal glans penis in centimeters
change in EF
Time frame: baseline to 3 months after first device use
Measurement of penile length from corona to dorsal glans penis in centimeters
change in EF
Time frame: baseline to 6 months after first device use
Measurement of penile length from corona to dorsal glans penis in centimeters
change in EF
Time frame: baseline to 9 months after first device use
Measurement of penile length from corona to dorsal glans penis in centimeters
change in EF
Time frame: baseline to 12 months after first device use
Measurement of penile length from corona to dorsal glans penis in centimeters
15 secondary outcomes
change in urinary control
Time frame: baseline to 6 weeks after first device use
change in urinary control
Time frame: baseline to 3 months after first device use
change in urinary control
Time frame: baseline to 6 months after first device use
change in urinary control
Time frame: baseline to 9 months after first device use
change in urinary control
Time frame: baseline to 12 months after first device use
change in urinary control
Time frame: baseline to 6 weeks after first device use
change in urinary control
Time frame: baseline to 3 months after first device use
change in urinary control
Time frame: baseline to 6 months after first device use
change in urinary control
Time frame: baseline to 9 months after first device use
change in urinary control
Time frame: baseline to 12 months after first device use
change in urinary control
Time frame: baseline to 6 weeks after first device use
change in urinary control
Time frame: baseline to 3 months after first device use
change in urinary control
Time frame: baseline to 6 months after first device use
change in urinary control
Time frame: baseline to 9 months after first device use
change in urinary control
Time frame: baseline to 12 months after first device use
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arthur L Burnett, MD, MBA principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Viberect device in people with Erectile Dysfunction Following Radical Prostatectomy and Urinary Incontinence of Non-organic Origin, run by Johns Hopkins University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in erectile function (time frame: baseline to 6 weeks after first device use). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2019.