None listed
Conditions
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.
Interventions
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 w
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
Sponsors
University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
We intend to recruit 40 healthy males, aged >18years with a history of Peyronie’s Disease.
Exclusion criteria
Exclusion criteria - History of diabetes type 1 or 2. - Current smokers (<1 year post cessation)
Outcome results
None listed