The Use of Ultrasound in Assessing Post-prostatectomy Erectile Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ulrasound Vibroelastography (UVE).
- Who it may be relevant to
- Registry conditions: Prostate Adenocarcinoma. Basic parameters: from 40 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Ultrasound Vibroelastography in Post-Prostatectomy Erectile Dysfunction
Overview
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.
Interventions
- Diagnostic test Ulrasound Vibroelastography (UVE)
Ultrasound technique to quantitatively assess tissue stiffness (elasticity and viscosity) by applying vibration through a specialized probe (indenter).
Primary outcome measures
- Change in Viscoelasticity [Time frame: Baseline, 3 months, 6 months and 9 months post-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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT05109208 · 21-001713