Trial Outcomes & Findings for Assessment of Penile Vibratory Stimulation Using the Viberect in Men With Mild-Moderate ED (NCT NCT01715571)

NCT ID: NCT01715571

Last Updated: 2021-06-23

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: baseline
• Results posted on: 2021-06-23

Participant Flow

Participant milestones

Measure	Viberect Treatment 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
Overall Study STARTED	11
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	Viberect Treatment 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
Overall Study Lost to Follow-up	8

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Viberect Treatment n=11 Participants Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	50.9 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

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.

Outcome measures

Measure	Viberect Treatment n=3 Participants Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire	21.3 score on a scale Standard Deviation 16.1

PRIMARY outcome

Timeframe: Baseline

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.

Outcome measures

Measure	Viberect Treatment n=3 Participants Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
Acceptability of Use of the Viberect as Assessed by TSS	25 score on a scale Standard Deviation 6.1

PRIMARY outcome

Timeframe: Week 4

Population: Patient 1 data is missing.

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.

Outcome measures

Measure	Viberect Treatment n=2 Participants Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire	15 score on a scale Standard Deviation 12.7

PRIMARY outcome

Timeframe: week 4

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.

Outcome measures

Measure	Viberect Treatment n=3 Participants Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
Acceptability of Use of the Viberect as Assessed by TSS	38.3 score on a scale Standard Deviation 16.1

SECONDARY outcome

Timeframe: baseline

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

Outcome measures

Measure	Viberect Treatment n=3 Participants Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
Erectile Function (EF) as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire	14.6 score on a scale Standard Deviation 1.15

SECONDARY outcome

Timeframe: baseline

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.

Outcome measures

Measure	Viberect Treatment n=3 Participants Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
EF as Assessed by the Erectile Hardness Score (EHS)	2.33 score on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: Week 4

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

Outcome measures

Measure	Viberect Treatment n=3 Participants Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
EF as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire	16.3 score on a scale Standard Deviation 1.52

SECONDARY outcome

Timeframe: Week 4

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.

Outcome measures

Measure	Viberect Treatment n=3 Participants Single-center, non-randomized, single-arm study Participants received Viberect treatment for 4 weeks of daily home use in preparation for sexual activity
EF as Assessed by the Erectile Hardness Score (EHS)	2.66 score on a scale Standard Deviation 0.5

Adverse Events

Viberect Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Arthur Burnett, MD

Johns Hopkins University School of Medicine

Phone: 410-614-3986

Email: aburnet1@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place