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Assessment of Penile Vibratory Stimulation Using the Viberect in Men With Mild-Moderate ED

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01715571
Recruitment Status : Terminated (Unable to obtain adequate recruitment)
First Posted : October 29, 2012
Results First Posted : June 23, 2021
Last Update Posted : June 23, 2021
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Organic Erectile Dysfunction
Intervention Device: Viberect
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Viberect Treatment
Hide Arm/Group Description Single-center, non-randomized, single-arm study The Viberect device was used for 7-10 minutes at least 3 times each week, at least 24 hours apart, 4 weeks period
Period Title: Overall Study
Started 11
Completed 3
Not Completed 8
Reason Not Completed
Lost to Follow-up             8
Arm/Group Title Viberect Treatment
Hide Arm/Group Description Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
10
  90.9%
>=65 years
1
   9.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
50.9  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female 0
Male 11
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
5
  45.5%
White
6
  54.5%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
 100.0%
1.Primary Outcome
Title Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire
Hide Description The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect. Each item is a 5-point Likert-type scale from 0 "no satisfaction or dissatisfaction" to 4 "high satisfaction." Total scoring ranges from 0-44 with higher scores indicating higher treatment satisfaction.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Viberect Treatment
Hide Arm/Group Description:
Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: score on a scale
21.3  (16.1)
2.Primary Outcome
Title Acceptability of Use of the Viberect as Assessed by TSS
Hide Description The Treatment Satisfaction Scale (TSS) questionnaire (patient baseline module) will be administered addressing participant satisfaction before Viberect treatment; This is an 8 item tool and each item is a 5-point Likert-type scale from 1 to 5. The score range for TSS is 8-40 with higher scores indicating greater dissatisfaction.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Viberect Treatment
Hide Arm/Group Description:
Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: score on a scale
25  (6.1)
3.Primary Outcome
Title Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire
Hide Description The Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire will be administered. This is an 11 item tool addressing participant satisfaction with the Viberect. Each item is a 5-point Likert-type scale from 0 "no satisfaction or dissatisfaction" to 4 "high satisfaction." Total scoring ranges from 0-44 with higher scores indicating higher treatment satisfaction.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Patient 1 data is missing.
Arm/Group Title Viberect Treatment
Hide Arm/Group Description:
Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
Overall Number of Participants Analyzed 2
Mean (Standard Deviation)
Unit of Measure: score on a scale
15  (12.7)
4.Primary Outcome
Title Acceptability of Use of the Viberect as Assessed by TSS
Hide Description The Treatment Satisfaction Scale (TSS) questionnaire (patient active treatment module) will be administered addressing participant satisfaction following Viberect treatment; This is a 13 item tool and each item is a 5-point Likert-type scale from 1 to 5. The score range for TSS is 13-65 with higher scores indicating greater dissatisfaction.
Time Frame week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Viberect Treatment
Hide Arm/Group Description:
Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: score on a scale
38.3  (16.1)
5.Secondary Outcome
Title Erectile Function (EF) as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire
Hide Description The International Index for Erectile Function (IIEF)-5 questionnaire will be administered. This is a 5 item tool; addressing Erectile function over the previous 4 weeks. Scores from 1-25 can be obtained in this domain. Scores are interpreted as follows: 1-7 = Severe Erectile dysfunction (ED), 8-11 = Moderate ED, 12-16 = mild-moderate ED, 17-21 = mild ED, 22-25 = No ED
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Viberect Treatment
Hide Arm/Group Description:
Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: score on a scale
14.6  (1.15)
6.Secondary Outcome
Title EF as Assessed by the Erectile Hardness Score (EHS)
Hide Description The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single-item tool. It is scored from 1 to 4. Higher scores indicate better erection rigidity.
Time Frame baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Viberect Treatment
Hide Arm/Group Description:
Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.33  (0.5)
7.Secondary Outcome
Title EF as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire
Hide Description The International Index for Erectile Function (IIEF)-5 questionnaire will be administered. This is a 5 item tool; addressing Erectile function over the previous 4 weeks. Scores from 1-25 can be obtained in this domain. Scores are interpreted as follows: 1-7 = Severe Erectile dysfunction (ED), 8-11 = Moderate ED, 12-16 = mild-moderate ED, 17-21 = mild ED, 22-25 = No ED
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Viberect Treatment
Hide Arm/Group Description:
Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: score on a scale
16.3  (1.52)
8.Secondary Outcome
Title EF as Assessed by the Erectile Hardness Score (EHS)
Hide Description The Erectile Hardness Score (EHS) questionnaire will be administered. it is a single-item tool. It is scored from 1 to 4. Higher scores indicate better erection rigidity.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Viberect Treatment
Hide Arm/Group Description:
Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
Overall Number of Participants Analyzed 3
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.66  (0.5)
Time Frame 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Viberect Treatment
Hide Arm/Group Description Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
All-Cause Mortality
Viberect Treatment
Affected / at Risk (%)
Total   0/11 (0.00%) 
Hide Serious Adverse Events
Viberect Treatment
Affected / at Risk (%)
Total   0/11 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Viberect Treatment
Affected / at Risk (%)
Total   0/11 (0.00%) 
Among the limitations of this study are the small number of subjects, short duration of therapy, and a single-arm design with no control group.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Arthur Burnett, MD
Organization: Johns Hopkins University School of Medicine
Phone: 410-614-3986
EMail: aburnet1@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01715571    
Other Study ID Numbers: IRB00130002
First Submitted: October 21, 2012
First Posted: October 29, 2012
Results First Submitted: May 14, 2021
Results First Posted: June 23, 2021
Last Update Posted: June 23, 2021