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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]

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

Condition category

Condition code

Renal and Urogenital

Other renal and urogenital disorders

Reproductive Health and Childbirth

Other reproductive health and childbirth disorders

Surgery

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]

Treatment: Devices

Intervention code [2]

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]

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]

At 6 and 12 months. The durability of the clinical success will be monitored annually for 5 years

Primary outcome [2]

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]

At 6 and 12 months. The durability of the clinical success will be monitored annually for 5 years

Secondary outcome [1]

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]

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]

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]

At the end of the procedure.

Secondary outcome [3]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Other

Name [1]

In-kind, Radiology Research Unit, The Alfred

Address [1]

55 Commercial Road
Melbourne, Vic 3004
Australia

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Alfred Hospital Ethics Committee

Ethics committee address [1]

Office of Ethics & Research Governance
Level 5, 553 St Kilda Rd
Melbourne Vic 3004
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/07/2020

Approval date [1]

24/09/2020

Ethics approval number [1]

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

Dr Heather Moriarty

Address

Radiology Department
The Alfred
55 Commercial Road
Melbourne Vic 3004

Country

Australia

Phone

+61 3 90762000

Fax

+61 3 90762760

h.moriarty@alfred.org.au

Contact person for public queries

Name

Helen Kavnoudias

Address

Radiology Department
The Alfred
55 Commercial Road
Melbourne Vic 3004

Country

Australia

Phone

+61 413027175

Fax

+61 3 90762760

h.kavnoudias@alfred.org.au

Contact person for scientific queries

Name

Heather Moriarty

Address

Radiology Department
The Alfred
55 Commercial Road
Melbourne Vic 3004

Country

Australia

Phone

+61 3 90762000

Fax

+61 3 90762760

h.moriarty@alfred.org.au

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, t.phan@alfred.org.au
Dr Moriarty, h.moriarty@alfred.org.au
Dr Helen Kavnoudias, h.kavnoudias@alfred.org.au

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

Source	Title	Year of Publication	DOI
Embase	PIVET-ED: A Prospective, Randomised, Single-Blinded, Sham Controlled Study of Pelvic Vein Embolisation for Treatment of Erectile Dysfunction.	2022	https://dx.doi.org/10.1007/s00270-021-03021-x

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

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