None listed
Conditions
Brief summary
Erectile Dysfunction (ED) affects the quality of life of more than 50% of men aged over 40 years. Diagnosis is complex and requires a multidisciplinary approach. Treatment begins with lowering cardiovascular risks followed by oral medication. Third line is treatment with invasive procedures for example, intracavernosal injections, surgical ligations and implants. Venogenic involvement is one of the causes of ED and is diagnosed by cavernosography. Venogenic ED (vED) may be treated surgically or by the endovascular technique Pelvic Vein Embolisation (PVE). A 2019 review (8 studies, 212 pts) found that PVE was safer than surgical management and the success rate was cited as 60%. However, well-designed trials are lacking in the literature. Published data is limited by small patient numbers, study design and short follow up. Based on the positive findings in the 2019 review and because of our increasing referral rate, we aim to conduct a Level 1, randomised, single blinded, sham controlled study to assess the safety, efficacy and durability of PVE for the treatment of vED. As per standard of care, patients with suspected vED will be referred to Interventional Radiology (IR) by urologists. They will be seen in the IR clinic, counselled and if suitable, booked for cavernosography +/- PVE. 80 patients will be randomised 1:1 to PVE or sham after the cavernosography. Safety will be assessed by determining the composite number of procedural and post procedural complications. Efficacy and durability will be assessed quantitatively with pelvic vein Doppler ultrasound (End Diastolic Velocity (EDV) <5 cm/s) and qualitatively with the validated Quality of Life - International Index of Erectile Function (IIEF) patient questionnaire. Assessments will be made prior to the procedure, at 6 months and annually to 5 years. At the 12 month time point, patients in the sham arm will be able to have the procedure.
Interventions
Cavernosography ± PVE is done within the one procedure.
The study Interventional Radiologists will be performing the Cavernosography ± PVE procedure. They are experienced and perform up to 40 procedures per year.
The whole procedure is done under angiographic image guidance. The first step of the angiographic procedure, is to use diagnostic cavernosograpy to confirm venogenic ED. When venogenic involvement is confirmed the Interventional Radiologist will proceed to step two and embolise the p
Cavernosography ± PVE is done within the one procedure. The study Interventional Radiologists will be performing the Cavernosography ± PVE procedure. They are experienced and perform up to 40 procedures per year. The whole procedure is done under angiographic image guidance. The first step of the angiographic procedure, is to use diagnostic cavernosograpy to confirm venogenic ED. When venogenic involvement is confirmed the Interventional Radiologist will proceed to step two and embolise the pelvic vein. This is the current standard practice. For the trial, participants randomised to the treatment arm will have the PVE, participants randomised to the sham arm will not proceed to the embolization part of the procedure. The average time for a Cavernosography ± PVE is 1 to 1½ hours. Patients are administered IV sedation. The right internal jugular vein is accessed using ultrasound guidance. A 5fr sheath is inserted. A 5fr catheter is advanced over a wire to the pelvic veins identified on cavernosography. Between 3-10ml glue (n-butyl-2-cyanoacrylate, B Braun, Melsungen, AG) is injected, under angiographic control. Subsequently repeat cavernosograpy is performed to ensure adequate embolisation, if necessary repeat embolisation is performed. To ensure blinding is not compromised the duration of the sham procedure will be extended to approximately 1 hour. Procedural medical records will only include information about the patient’s participation in the trial and the IRs telephone number. The procedure details will be added to the patients’ medical record at the end of the trial.
Sponsors
Alfred Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Males aged 18 to 75 referred for cavernosography and embolization. Signed study Participant Information and Consent Form
Exclusion criteria
No pelvic venous opacification at the time of correctly performed diagnostic cavernosography. No prior embolisation or surgical ligation procedures for the treatment of ED secondary to venous leak.
Outcome results
None listed