Back to resultsThe Use of Ultrasound in Assessing Post-prostatectomy Erectile Dysfunction
Primary Purpose
Prostate Adenocarcinoma
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ulrasound Vibroelastography (UVE)
Sponsored by
About this trial
This is an interventional health services research trial for Prostate Adenocarcinoma focused on measuring Radical Prostatectomy
Eligibility Criteria
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
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ultrasound viscoelastography (UVE) in radical proctectomy recovery
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Viscoelasticity
As measured by Ultrasound Vibroelastography (UVE)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05109208
Brief Title
The Use of Ultrasound in Assessing Post-prostatectomy Erectile Dysfunction
Official Title
Ultrasound Vibroelastography in Post-Prostatectomy Erectile Dysfunction
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Suspended
Why Stopped
Given current healthcare environment, resource constraints have limited the ability to recruit participants. It is anticipated that the study will resume in the future, although the exact timing is currently unknown.
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Adenocarcinoma
Keywords
Radical Prostatectomy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ultrasound viscoelastography (UVE) in radical proctectomy recovery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Ulrasound Vibroelastography (UVE)
Intervention Description
Ultrasound technique to quantitatively assess tissue stiffness (elasticity and viscosity) by applying vibration through a specialized probe (indenter).
Primary Outcome Measure Information:
Title
Change in Viscoelasticity
Description
As measured by Ultrasound Vibroelastography (UVE)
Time Frame
Baseline, 3 months, 6 months and 9 months post-prostatectomy
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Ziegelmann, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
The Use of Ultrasound in Assessing Post-prostatectomy Erectile Dysfunction
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