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:
Johns Hopkins University
Information provided by (Responsible Party):
Johns Hopkins University
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Viberect Treatment |
---|---|
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 |
Baseline Characteristics
Arm/Group Title | Viberect Treatment | |
---|---|---|
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 | |
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%
|
Outcome Measures
Adverse Events
Limitations and Caveats
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.
More Information
Results Point of Contact
Name/Title: | Arthur Burnett, MD |
Organization: | Johns Hopkins University School of Medicine |
Phone: | 410-614-3986 |
EMail: | aburnet1@jhmi.edu |
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 |