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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] 292951 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peyronies Disease 304848 0
Condition category
Condition code
Physical Medicine / Rehabilitation 304148 304148 0 0
Physiotherapy
Renal and Urogenital 304214 304214 0 0
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] 299190 0
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] 303463 0
.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] 303463 0
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] 338994 0
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] 338994 0
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] 339221 0
Erectile function is to be assessed using the International Index of Erectile Function (IIEF)
Timepoint [2] 339221 0
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?
No
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
40
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 297578 0
Commercial sector/Industry
Name [1] 297578 0
SKG Radiology Hollywood
Country [1] 297578 0
Australia
Funding source category [2] 297651 0
Self funded/Unfunded
Name [2] 297651 0
Joanne Milios
Country [2] 297651 0
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] 296591 0
Individual
Name [1] 296591 0
Joanne Milios
Address [1] 296591 0
Complete Physiotherapy & Men's Health
U7/12 Davallia Rd,
Duncraig 6023
Western Australia
Country [1] 296591 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298670 0
Human Ethics Office of Research Enterprise The University of Western Australia
Ethics committee address [1] 298670 0
The University of Western Australia M459, 35 Stirling Highway Crawley WA 6009 Australia
Ethics committee country [1] 298670 0
Australia
Date submitted for ethics approval [1] 298670 0
19/02/2016
Approval date [1] 298670 0
03/05/2016
Ethics approval number [1] 298670 0
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 77842 0
Mrs Joanne Milios
Address 77842 0
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 77842 0
Australia
Phone 77842 0
+61 0408 022 950
Fax 77842 0
Email 77842 0
[email protected]
Contact person for public queries
Name 77843 0
Joanne Milios
Address 77843 0
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 77843 0
Australia
Phone 77843 0
+61 0408 022 950
Fax 77843 0
Email 77843 0
[email protected]
Contact person for scientific queries
Name 77844 0
Daniel Green
Address 77844 0
The University of Western Australia
Department of Human Services
Entrance 4 Parkway Rd,
Crawley 6009
Western Australia
Country 77844 0
Australia
Phone 77844 0
+61 0400 1968 01
Fax 77844 0
Email 77844 0
[email protected]

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

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