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The Use of Ultrasound in Assessing Post-prostatectomy Erectile Dysfunction

Sponsor
Mayo Clinic (Other)
Overall Status
Suspended
CT.gov ID
NCT05109208
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
12
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Researchers are trying to determine whether there is additional utility to using vibroelastography, a noninvasive ultrasound technique to evaluate for the presence of tissue fibrosis, in conjunction with standard penile duplex Doppler ultrasound to assess erectile function (recovery) after prostate cancer surgery.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Ulrasound Vibroelastography (UVE)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Ultrasound Vibroelastography in Post-Prostatectomy Erectile Dysfunction
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ultrasound viscoelastography (UVE) in radical proctectomy recovery

Subjects undergoing radical prostatectomy for prostate cancer disease as standard of care will have a ultrasound vibroelastography performed before surgery, 3 months, 6 months and 9 months post-prostatectomy.

Diagnostic Test: Ulrasound Vibroelastography (UVE)
Ultrasound technique to quantitatively assess tissue stiffness (elasticity and viscosity) by applying vibration through a specialized probe (indenter).

Outcome Measures

Primary Outcome Measures

  1. Change in Viscoelasticity [Baseline, 3 months, 6 months and 9 months post-prostatectomy]

    As measured by Ultrasound Vibroelastography (UVE)

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion criteria include:

  • Age > 40 years

  • Clinically localized prostate cancer (American Urological Association Grade Groups 1-2; cT1c or cT2a-b; PSA < 10) without clinic or imaging evidence of localized extra-prostatic or metastatic disease (i.e. AUA low and favorable intermediate risk prostate cancer)

  • International Index of Erectile Function (IIEF) of ≥ 21 points at baseline (no or mild erectile dysfunction)

  • Patient-expressed interest in consultation for sexual function (erectile function) preservation/ optimization

  • Planned bilateral nerves-paring prostatectomy

Exclusion criteria include:

  • Moderate or severe ED based in IIEF criteria (score < 21)

  • History of prior pelvic or penile surgery

  • Current or prior androgen deprivation therapy

  • Planned non-nerve sparing prostatectomy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Mayo Clinic

Investigators

  • Principal Investigator: Matthew Ziegelmann, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Matthew (Matt) J. Ziegelmann, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05109208
Other Study ID Numbers:
  • 21-001713
First Posted:
Nov 5, 2021
Last Update Posted:
Jan 14, 2022
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Matthew (Matt) J. Ziegelmann, Principal Investigator, Mayo Clinic
Radical Prostatectomy
Additional relevant MeSH terms:
Erectile Dysfunction

Study Results

No Results Posted as of Jan 14, 2022