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Viberect Penile Vibratory Stimulation to Enhance Recovery of Erectile Function and Urinary Continence Post-Prostatectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01718704
First received: October 24, 2012
Last updated: September 20, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Erectile Dysfunction Following Radical Prostatectomy
Urinary Incontinence of Non-organic Origin
Device: Viberect device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • change in erectile function [ Time Frame: baseline to 6 weeks after first device use ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Measurement of penile length from corona to dorsal glans penis in centimeters


Secondary Outcome Measures:
  • change in urinary control [ Time Frame: baseline to 6 weeks after first device use ] [ Designated as safety issue: No ]
    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

  • change in urinary control [ Time Frame: baseline to 3 months after first device use ] [ Designated as safety issue: No ]
    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

  • change in urinary control [ Time Frame: baseline to 6 months after first device use ] [ Designated as safety issue: No ]
    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

  • change in urinary control [ Time Frame: baseline to 9 months after first device use ] [ Designated as safety issue: No ]
    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

  • change in urinary control [ Time Frame: baseline to 12 months after first device use ] [ Designated as safety issue: No ]
    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

  • change in urinary control [ Time Frame: baseline to 6 weeks after first device use ] [ Designated as safety issue: No ]
    Mass of incontinence guards used over a 24 hour period in grams

  • change in urinary control [ Time Frame: baseline to 3 months after first device use ] [ Designated as safety issue: No ]
    Mass of incontinence guards used over a 24 hour period in grams

  • change in urinary control [ Time Frame: baseline to 6 months after first device use ] [ Designated as safety issue: No ]
    Mass of incontinence guards used over a 24 hour period in grams

  • change in urinary control [ Time Frame: baseline to 9 months after first device use ] [ Designated as safety issue: No ]
    Mass of incontinence guards used over a 24 hour period in grams

  • change in urinary control [ Time Frame: baseline to 12 months after first device use ] [ Designated as safety issue: No ]
    Mass of incontinence guards used over a 24 hour period in grams

  • change in urinary control [ Time Frame: baseline to 6 weeks after first device use ] [ Designated as safety issue: No ]
    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

  • change in urinary control [ Time Frame: baseline to 3 months after first device use ] [ Designated as safety issue: No ]
    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

  • change in urinary control [ Time Frame: baseline to 6 months after first device use ] [ Designated as safety issue: No ]
    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

  • change in urinary control [ Time Frame: baseline to 9 months after first device use ] [ Designated as safety issue: No ]
    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

  • change in urinary control [ Time Frame: baseline to 12 months after first device use ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • change in assessment of ease and acceptability of use of the Viberect [ Time Frame: 6 weeks after first device use to 3 months ] [ Designated as safety issue: No ]
    The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction

  • change in assessment of ease and acceptability of use of the Viberect [ Time Frame: 6 weeks after first device use to 6 months ] [ Designated as safety issue: No ]
    The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction

  • change in assessment of ease and acceptability of use of the Viberect [ Time Frame: 6 weeks after first device use to 9 months ] [ Designated as safety issue: No ]
    The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction

  • change in assessment of ease and acceptability of use of the Viberect [ Time Frame: 6 weeks after first device use to 12 months ] [ Designated as safety issue: No ]
    The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction

  • change in assessment of ease and acceptability of use of the Viberect [ Time Frame: baseline to 6 weeks after first device use ] [ Designated as safety issue: No ]
    The Treatment Satisfaction Scale (TSS) questionnaire will be administered. This is an 21 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction

  • change in assessment of ease and acceptability of use of the Viberect [ Time Frame: baseline to 3 months after first device use ] [ Designated as safety issue: No ]
    The Treatment Satisfaction Scale (TSS) questionnaire will be administered. This is an 21 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction

  • change in assessment of ease and acceptability of use of the Viberect [ Time Frame: baseline to 6 months after first device use ] [ Designated as safety issue: No ]
    The Treatment Satisfaction Scale (TSS) questionnaire will be administered. This is an 21 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction

  • change in assessment of ease and acceptability of use of the Viberect [ Time Frame: baseline to 9 months after first device use ] [ Designated as safety issue: No ]
    The Treatment Satisfaction Scale (TSS) questionnaire will be administered. This is an 21 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction

  • change in assessment of ease and acceptability of use of the Viberect [ Time Frame: baseline to 12 months after first device use ] [ Designated as safety issue: No ]
    The Treatment Satisfaction Scale (TSS) questionnaire will be administered. This is an 21 item tool addressing participant satisfaction with the Viberect; higher scores indicate greater dissatisfaction


Estimated Enrollment: 105
Study Start Date: April 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Viberect device
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.
Device: Viberect device
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.
No Intervention: No Viberect
Men in this group will not be provided with the Viberect device

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718704

Contacts
Contact: Kambiz Tajkarimi, MD 1-202-321-8162 Kambiz123@hotmail.com
Contact: Jordan Dimitrakoff, MD, PhD 410-502-5384 jdimitr1@jhmi.edu

Locations
United States, Maryland
Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Jordan Dimitrakoff, M.D., Ph.D.    410-502-5384    jdimitr1@jhmi.edu   
Contact: Brian Le, M.D.       ble6@jhmi.edu   
Principal Investigator: Arthur L Burnett, MD, MBA         
Frederick Urology Specialists Recruiting
Frederick, Maryland, United States, 21701
Contact: Kambiz Tajkarimi, MD       kambiz123@hotmail.com   
Principal Investigator: Kambiz Tajkarimi, MD         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Arthur L Burnett, MD, MBA Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01718704     History of Changes
Other Study ID Numbers: NA_00069795 
Study First Received: October 24, 2012
Last Updated: September 20, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
rehabilitation
erectile dysfunction
incontinence

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Erectile Dysfunction
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological

ClinicalTrials.gov processed this record on September 27, 2016