The Use of Ultrasound in Assessing Post-prostatectomy Erectile Dysfunction
ConditionProstate Adenocarcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Ulrasound Vibroelastography (UVE)
Diagnostic testUltrasound technique to quantitatively assess tissue stiffness (elasticity and viscosity) by applying vibration through a specialized probe (indenter).
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Ultrasound viscoelastography (UVE) in radical proctectomy recoveryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Viscoelasticity
As measured by Ultrasound Vibroelastography (UVE)
Time frame
Baseline, 3 months, 6 months and 9 months post-prostatectomySponsors and contacts
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Source ClinicalTrials.gov