NCT01718704

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 31, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2019

Completed
Last Updated

May 24, 2019

Status Verified

May 1, 2019

Enrollment Period

6 years

First QC Date

October 24, 2012

Last Update Submit

May 22, 2019

Conditions

Erectile Dysfunction Following Radical ProstatectomyUrinary Incontinence of Non-organic Origin

Keywords

rehabilitationerectile dysfunctionincontinence

Outcome Measures

Primary Outcomes (20)

  • change in erectile function

    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

    baseline to 6 weeks after first device use

  • change in 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

    baseline to 3 months after first device use

  • change in 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

    baseline to 6 months after first device use

  • change in erectile function

    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

    baseline to 9 months after first device use

  • change in erectile function

    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

    baseline to 12 months after first device use

  • change in erectile function

    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

    baseline to 6 weeks after first device use

  • change in erectile function

    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

    baseline to 3 months after first device use

  • change in erectile function

    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

    baseline to 6 months after first device use

  • change in erectile function

    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

    baseline to 9 months after first device use

  • change in erectile function

    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

    baseline to 12 months after first device use

  • change in erectile function

    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

    baseline to 6 weeks after first device use

  • change in erectile function

    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

    baseline to 3 months after first device use

  • change in erectile function

    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

    baseline to 6 months after first device use

  • change in erectile function (EF)

    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

    baseline to 9 months after first device use

  • change in EF

    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

    baseline to 12 months after first device use

  • change in EF

    Measurement of penile length from corona to dorsal glans penis in centimeters

    baseline to 6 weeks after first device use

  • change in EF

    Measurement of penile length from corona to dorsal glans penis in centimeters

    baseline to 3 months after first device use

  • change in EF

    Measurement of penile length from corona to dorsal glans penis in centimeters

    baseline to 6 months after first device use

  • change in EF

    Measurement of penile length from corona to dorsal glans penis in centimeters

    baseline to 9 months after first device use

  • change in EF

    Measurement of penile length from corona to dorsal glans penis in centimeters

    baseline to 12 months after first device use

Secondary Outcomes (15)

  • change in urinary control

    baseline to 6 weeks after first device use

  • change in urinary control

    baseline to 3 months after first device use

  • change in urinary control

    baseline to 6 months after first device use

  • change in urinary control

    baseline to 9 months after first device use

  • change in urinary control

    baseline to 12 months after first device use

  • +10 more secondary outcomes

Other Outcomes (9)

  • change in assessment of ease and acceptability of use of the Viberect

    6 weeks after first device use to 3 months

  • change in assessment of ease and acceptability of use of the Viberect

    6 weeks after first device use to 6 months

  • change in assessment of ease and acceptability of use of the Viberect

    6 weeks after first device use to 9 months

  • +6 more other outcomes

Study Arms (2)

Viberect device

EXPERIMENTAL

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

No Viberect

NO INTERVENTION

Men in this group will not be provided with the Viberect device

Interventions

Viberect deviceDEVICE

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.

Viberect device

Eligibility Criteria

Age40 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Frederick Urology Specialists

Frederick, Maryland, 21701, United States

Location

MeSH Terms

Conditions

Nocturnal EnuresisErectile Dysfunction

Condition Hierarchy (Ancestors)

EnuresisUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental DisordersGenital Diseases, MaleGenital DiseasesSexual Dysfunction, PhysiologicalSexual Dysfunctions, Psychological

Study Officials

  • Arthur L Burnett, MD, MBA

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2012

First Posted

October 31, 2012

Study Start

April 1, 2013

Primary Completion

March 27, 2019

Study Completion

March 27, 2019

Last Updated

May 24, 2019

Record last verified: 2019-05

Locations

US(2)