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Trial registered on ANZCTR


Registration number
ACTRN12620001023943
Ethics application status
Approved
Date submitted
15/07/2020
Date registered
8/10/2020
Date last updated
8/10/2020
Date data sharing statement initially provided
8/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A prospective, randomised, single-blinded, sham controlled study of pelvic vein embolisation for treatment of erectile dysfunction.
Scientific title
A prospective, randomised, single-blinded, sham controlled study of pelvic vein embolisation for treatment of erectile dysfunction.
Secondary ID [1] 301770 0
Nil known
Universal Trial Number (UTN)
U1111-1255-3114
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Erectile dysfunction 318235 0
Condition category
Condition code
Renal and Urogenital 316245 316245 0 0
Other renal and urogenital disorders
Reproductive Health and Childbirth 316923 316923 0 0
Other reproductive health and childbirth disorders
Surgery 316924 316924 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 318062 0
Treatment: Devices
Intervention code [2] 318776 0
Diagnosis / Prognosis
Comparator / control treatment
This is a randomised, sham controlled study.
The control group will have the cavernosography but will not proceed to embolisation. The patient will be blinded as to whether they received the the pelvic vein embolisation or not.
To ensure blinding is not compromised the duration of the sham procedure will be extended to approximately 1 hour which is the average time for the full cavernosography + PVE procedure.
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.
Control group
Placebo

Outcomes
Primary outcome [1] 324428 0
Clinical success at 6 and 12 months post venous embolisation for management of venogenic ED, as defined by a >4-point improvement in International index of erectile function (IIEF) (validated patient questionnaire).
Timepoint [1] 324428 0
At 6 and 12 months. The durability of the clinical success will be monitored annually for 5 years
Primary outcome [2] 324429 0
Clinical success at 6 and 12 months post venous embolisation for management of venogenic ED, as defined by end diastolic velocity (EDV) <5 cm/s with Doppler-ultrasound.
Timepoint [2] 324429 0
At 6 and 12 months. The durability of the clinical success will be monitored annually for 5 years
Secondary outcome [1] 384610 0
Safety assessed by the composite number of procedural and post procedural complications as defined by the 2017 CIRSE guidelines.

The known procedure risks of cavernosography and PVE have an incidence rate of <1% and include: Infection and/or bleeding at the puncture sites, dizziness, headache, hypotension, nausea, penile pain/rash/itch, priapism, failure to embolise (cannot access the veins), contrast allergy, non-target embolisation - eg Deep Vein Thrombosis/Pulmonary Embolus

Procedural complications will be addressed and recorded. Post procedure complications will be determined during out-patient clinic consultation on, or before if required, the trial follow-up timepoints (6, 12, 24, 36, 48, 60 months). The patients hospital records will be reviewed and if the patients are seen by an external provider, with the patients' consent, the relevant medical records with be requested for review.
Timepoint [1] 384610 0
Safety and adverse events will be recorded for the duration of the study and will include the following time points:
Procedure, pre-discharge, 24 hours, 1 week, 1, 6, 12, 24, 36, 48 and 60 months.
Secondary outcome [2] 384611 0
Technical success of venous embolisation defined as adequate periprostatic venous plexus embolization with visualization of occlusion at end of the procedure using Digital Subtraction Angiography (DSA)
Timepoint [2] 384611 0
At the end of the procedure.
Secondary outcome [3] 384612 0
Durability of the embolization procedure as defined by a >4-point improvement in International index of erectile function (IIEF) (validated patient questionnaire) and as defined by end diastolic velocity (EDV) <5 cm/s with Doppler-ultrasound.
Timepoint [3] 384612 0
At 6 months post-intervention, then annually post-intervention for 5 years,

Eligibility
Key inclusion criteria
Males aged 18 to 75 referred for cavernosography and embolization.
Signed study Participant Information and Consent Form
Minimum age
18 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
randomised, single-blinded, sham controlled
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Studies evaluating efficacy of PVE for ED are limited. Sample size calculations were based on data for alternative therapy for ED and on the data presented in the 2019 meta-analysis (Doppalapudi SK et al 2019) . With 40 patients per group this study should have an 80% power to detect a difference in a continuously normally distributed outcome equivalent to 1/2 standard deviation with a two-sided p-value of 0.05.
Data analysis will involve confirmation of data characteristic followed by appropriate testing. Parametric data will be analysed with student t-testing, while non-parametric variables will be analysed using Wilcoxon Rank Sum testing. Binomial data will be analysed using Chi Squared of Fisher’s Exact testing as appropriate. P <0.05 will be considered significant. Safety will be assessed using a Z-statistic/Kaplan-Meier estimate of freedom from major adverse events at 12 months.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/10/2020
Actual
Date of last participant enrolment
Anticipated
15/12/2022
Actual
Date of last data collection
Anticipated
31/03/2026
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17074 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 30747 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 306201 0
Other
Name [1] 306201 0
In-kind, Radiology Research Unit, The Alfred
Country [1] 306201 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Radiology Dept
The Alfred
55 Commercial Road
Melbourne Vic 3004
Country
Australia
Secondary sponsor category [1] 306675 0
None
Name [1] 306675 0
Address [1] 306675 0
Country [1] 306675 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306413 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 306413 0
Office of Ethics & Research Governance
Level 5, 553 St Kilda Rd
Melbourne Vic 3004
Australia
Ethics committee country [1] 306413 0
Australia
Date submitted for ethics approval [1] 306413 0
01/07/2020
Approval date [1] 306413 0
24/09/2020
Ethics approval number [1] 306413 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103786 0
Dr Heather Moriarty
Address 103786 0
Radiology Department
The Alfred
55 Commercial Road
Melbourne Vic 3004
Country 103786 0
Australia
Phone 103786 0
+61 3 90762000
Fax 103786 0
+61 3 90762760
Email 103786 0
[email protected]
Contact person for public queries
Name 103787 0
Helen Kavnoudias
Address 103787 0
Radiology Department
The Alfred
55 Commercial Road
Melbourne Vic 3004
Country 103787 0
Australia
Phone 103787 0
+61 413027175
Fax 103787 0
+61 3 90762760
Email 103787 0
[email protected]
Contact person for scientific queries
Name 103788 0
Heather Moriarty
Address 103788 0
Radiology Department
The Alfred
55 Commercial Road
Melbourne Vic 3004
Country 103788 0
Australia
Phone 103788 0
+61 3 90762000
Fax 103788 0
+61 3 90762760
Email 103788 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified baseline and endpoint data.
When will data be available (start and end dates)?
It is anticipated that the 12 month primary endpoint data will be available at the end of year three of the study (approx. December 2023). It is anticipated that the final 5 year complete data set will be available by December 2027.
As per The Alfred HREC requirements the data will be available indefinitely.
Available to whom?
To medical journals if it is a requirement for the publication of the study manuscript written by the study investigators.
Available for what types of analyses?
Group outcome comparisons
How or where can data be obtained?
The data can be obtained from the study investigators
Dr Phan, [email protected]
Dr Moriarty, [email protected]
Dr Helen Kavnoudias, [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePIVET-ED: A Prospective, Randomised, Single-Blinded, Sham Controlled Study of Pelvic Vein Embolisation for Treatment of Erectile Dysfunction.2022https://dx.doi.org/10.1007/s00270-021-03021-x
N.B. These documents automatically identified may not have been verified by the study sponsor.