ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001415392

Ethics application status

Approved

Date submitted

21/09/2017

Date registered

6/10/2017

Date last updated

17/09/2018

Type of registration

Retrospectively registered

Titles & IDs

Public title

Ultrasound Therapy in Peyronie’s Disease: a non-invasive treatment.

Scientific title

Efficacy of Ultrasound Therapy in Peyronie’s Disease as a non-invasive treatment option.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Peyronies Disease

Condition category

Condition code

Physical Medicine / Rehabilitation

Physiotherapy

Renal and Urogenital

Other renal and urogenital disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Application of therapeutic ultrasound will be provided to men who have been diagnosed with Peyronies Disease. Twelve 10 min sessions of continuous ultrasound therapy at a dosage ranging from 1.5 w/cm2- 2.5w/cm2 depending on participants tolerance level , will be applied to the area of fibrosis as identified on penile duplex doppler ultrasound scan (PDDU), using a 3MHz sound head. This will be conducted over a 4 week period will be administered by a physiotherapist. Three sessions/week over 4 weeks is the plan for administering ultrasound . Adherence to the intervention will be ensured as each ultrasound session will be delivered to the participant by a physiotherapist

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Control group has a delayed entry of 4 weeks to receiving diagnostic ultrasound with pre and post PDDU scans, then subsequent 12 sessions of therapeutic ultrasound and repeat PDDU.

Control group

Active

Outcomes

Primary outcome [1]

.Therapeutic ultrasound may assist in the resolution of Peyronies Disease
This can be measured by an initial penile duplex doppler scan, (PDDU) which determines the presence and size of fibrosis and/ or plaque formation. The PDDU is completed pre-trial and post trial.to assess for changes in tissue pathology which is measured as a composite outcome.

Timepoint [1]

The PDDU is assessed pre -trial and following 12 sessions of therapeutic ultrasound, post-trial. approximately 4 weeks from the commencement of the intervention.

Secondary outcome [1]

A subjective Peyronies Disease Questionnaire (PDQ) is also utilised to determine subjective assessment of pain and function as a composite outcome .This is completed pre-trial and post trial.

Timepoint [1]

The PDQ is assessed pre -trial and following 12 sessions of therapeutic ultrasound, post-trial. approximately 4 weeks from the commencement of the intervention.

Secondary outcome [2]

Erectile function is to be assessed using the International Index of Erectile Function (IIEF)

Timepoint [2]

The IIEF will be administered pre- trial and following 12 sessions of therapeutic ultrasound approximately 4 weeks post commencement of intervention.

Eligibility

Key inclusion criteria

We intend to recruit 40 healthy males, aged >18years with a history of Peyronie’s Disease.

Minimum age

18 Years

Maximum age

No limit

Sex

Males

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria
- History of diabetes type 1 or 2.
- Current smokers (<1 year post cessation)

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)

Participants who are referred to the study will sequentially receive an envelope displaying either 'control' or 'intervention' group. If selected for control delayed entry of 4 weeks is instigated. If selected for the intervention group immediate commencement of the 12 sessions of therapeutic ultrasound.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

SPSS

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

1/07/2016

Date of last participant enrolment

Anticipated

31/10/2017

Actual

30/11/2017

Date of last data collection

Anticipated

31/12/2017

Actual

31/01/2018

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

SKG Radiology Hollywood

Address [1]

SKG Radiology Hollywood
95 Monash St,
Nedlands 6009

Country [1]

Australia

Funding source category [2]

Self funded/Unfunded

Name [2]

Joanne Milios

Address [2]

Complete Physiotherapy & Men's Health
U7/12 Davallia Rd,
Duncraig 6023
Western Australia

Country [2]

Australia

Primary sponsor type

University

Name

University of Western Australia

Address

Department of Human Services
Entrance 4 Parkway
Crawley 6009
Western Australia

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Joanne Milios

Address [1]

Complete Physiotherapy & Men's Health
U7/12 Davallia Rd,
Duncraig 6023
Western Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Human Ethics Office of Research Enterprise The University of Western Australia

Ethics committee address [1]

The University of Western Australia M459, 35 Stirling Highway Crawley WA 6009 Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/02/2016

Approval date [1]

03/05/2016

Ethics approval number [1]

RA/4/1/8089

Summary

Brief summary

The health of penile tissue is dependent on adequate blood flow. In Peyronie’s disease, fibrous plaques develop in the muscular tissue of the penis  as a result of reduced blood flow, caused by aging, diabetes or trauma such as surgery for prostate cancer.. The hardened plaques can be firm to feel,cause pain, prevent normal stretching and cause curvature of the penis, making sexual activity difficult or if severe enough, not possible.  The negative impact on quality of life is significant and more than 70% men with PD experience depression or relationship difficulties as a result. Currently, Peyronie’s disease is treated with surgical intervention or penile implant surgery, which may cause further scar tissue development, penile shortening and erectile dysfunction. Therapeutic ultrasound is commonly used to treat soft tissue trauma in musculoskeletal injuries and has no know side effects. It reduces inflammation, minimizes tissue damage, improves blood flow and helps soften scar tissue. The purpose of this study is to assess if therapeutic ultrasound assists in the resolution of Peyronies Disease.  

Rationale:
To date, treatment for Peyronie’s disease has been invasive or mostly ineffective. Surgical correction for example, shortens the penis and contributes to further fibrosis and scarring. Less invasive techniques such as injections have had mixed results and sometimes cause pain, inflammation and increased scarring. In a recent case, complete resolution of Peyronie’s disease occurred as a result of therapeutic ultrasound use, as analyzed under Doppler scan (Dr Kaard).In addition, Ms Milios has observed promising results in her clinical practice. There is also some evidence in the literature of older studies that ultrasound might be a useful therapy (Miller, HC, Ardizzone J. Urology 1983 22(6) 584-85, Frank IN, Scott WW. The ultrasonic treatment of Peyronie’s disease.1971 J o Urol 106 : 883) The pathophysiological mechanisms by which ultrasound might be effective are currently unknown ,but in theory relate to the piezoelectric force that bombards the fibrotic tissue via high intensity vibration and heating to a depth of up to 5cm (1 MHz soundhead).
In summary, there are clinical case reports and some non-randomized and uncontrolled experimental evidence that ultrasound might be helpful in the treatment of Peyronie’s Disease.

Trial website

Nil

Trial related presentations / publications

Nil

Public notes

SKG Hollywood provided a reduced rate for subsequent PDDU scans after patients paid for their initial scan, pre-trial scan

Contacts

Principal investigator

Name

Mrs Joanne Milios

Address

The University of Western Australia
Entrance 4, Parkway
Crawley 6009
Western Australia
and
Complete Physiotherapy & Men's Health
U7/12 Davallia Rd,
Duncraig 6023
Western Australia

Country

Australia

Phone

+61 0408 022 950

Fax

info.prost.inc@gmail.com

Contact person for public queries

Name

Joanne Milios

Address

The University of Western Australia
Entrance 4, Parkway
Crawley 6009
Western Australia
and
Complete Physiotherapy & Men's Health
U7/12 Davallia Rd,
Duncraig 6023
Western Australia

Country

Australia

Phone

+61 0408 022 950

Fax

info.prost.inc@gmail.com

Contact person for scientific queries

Name

Daniel Green

Address

The University of Western Australia
Department of Human Services
Entrance 4 Parkway Rd,
Crawley 6009
Western Australia

Country

Australia

Phone

+61 0400 1968 01

Fax

danny.green@uwa.edu.au

No information has been provided regarding IPD availability

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

No additional documents have been identified.

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