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

NCT01715571 | Terminated Results FDA Device

• 1 other identifier: IRB00130002
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of this study is to assess the safety, acceptability, and satisfaction of penile vibratory stimulation in treatment of erectile dysfunction (ED). The secondary objective is to demonstrate subjective physiological response (erection, rigidity, orgasm) after four weeks of frequent device use and the satisfaction of penile erection and sexual intercourse with partner.

Conditions

Organic Erectile Dysfunction

Keywords

erectile dysfunction; vibratory stimulation; viberect

Outcome Measures

Primary Outcomes (4)

• Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire

  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.

  baseline

• Acceptability of Use of the Viberect as Assessed by TSS

  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.

  Baseline

• Assessment of Ease/Acceptability of Use of the Viberect as Assessed by EDITS Questionnaire

  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.

  Week 4

• Acceptability of Use of the Viberect as Assessed by TSS

  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.

  week 4

Secondary Outcomes (4)

• Erectile Function (EF) as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire

  baseline

• EF as Assessed by the Erectile Hardness Score (EHS)

  baseline

• EF as Assessed by the International Index for Erectile Function (IIEF)-5 Questionnaire

  Week 4

• EF as Assessed by the Erectile Hardness Score (EHS)

  Week 4

Study Arms (1)

Viberect treatment

EXPERIMENTAL

Participants in this arm have documented mild to moderate ED of organic etiology and will be given the Viberect device for 4 weeks of daily home use in preparation for sexual activity. Men will be asked to use the device and attempt sexual intercourse at least 3 times weekly

Device: Viberect

Interventions

Viberect DEVICE

Men will be asked to perform vibratory stimulation of the penis in the privacy of their home, while focused on sexual thoughts for approximately 7-10 minutes (depending on erectile response) for 3 times a week, one day apart, throughout the four week period. Men can perform the stimulation once daily, as long as each session is more than 24 hours apart. Men will record device use and intercourse attempts after device use in a diary.

Viberect treatment

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mild-moderate erectile dysfunction based on International Index of Erectile Function (IIEF) erectile function score 13-25

You may not qualify if:

• Men with neurological disease
• IIEF score less than 13
• Spinal cord injury
• History of priapism
• Pelvic neuropathy
• Post-prostatectomy
• Penile skin lesions or ulcers
• Inability to understand and demonstrate device use instructions

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Frederick Urology Specialists

Frederick, Maryland, 21701, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

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.

Results Point of Contact

• Title: Arthur Burnett, MD
• Organization: Johns Hopkins University School of Medicine

aburnet1@jhmi.edu

410-614-3986

Study Officials

• Arthur L Burnett, MD, MBA

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2012
• First Posted: October 29, 2012
• Study Start: March 1, 2013
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: June 23, 2021
• Results First Posted: June 23, 2021

Record last verified: 2021-06

Locations

US (2)