Early Extracorporeal Shockwave Therapy for Erectile Dysfunction in Radically Prostatectomised Men.

Study Overview
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Brief Summary
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The purpose of this project is to assess the relationship between low intensity shock wave treatment (LI-SWT) and erectile function (ED) in patients who have undergone radical prostatectomy (RP).

Official Title
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Early Extracorporeal Shockwave Therapy for Erectile Dysfunction in Radically Prostatectomised Men.

Conditions
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Erectile Dysfunction, Extracorporeal Shockwave Therapy, Radical Prostatectomy

Intervention / Treatment
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* Device: Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Radically prostatectomised men Non nerve-sparing or nerve-sparing RP. Age 20-80 years Have been in a relationship for more than 3 months. Sexually active Patient can give informed consent. Exclusion Criteria: Men with ED of neuropathological or psychogenic origin Rectal extirpation, radiation therapy to the pelvic area and recovery from any other cancer within the past 5 years are excluded. Patients with heart disease prohibiting sexual activity or taking medication with antiandrogens, anticoagulant (apart from aspirin) or systemic use of glucocorticoids within 5 weeks.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised, single-blinded, placebo-controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active LI-ESWT<br>Active group receives five sessions of low intensity extracorporeal shockwave treatment, once per week for five consecutive weeks. Treatment is initiated three weeks after radical prostatectomy and is given using DUOLITH® SD1 manufactured by STORZ MEDICAL AG. | Device: Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)<br>* Five sessions of penile Low Intensity Extracorporeal Shockwave Therapy initiated three weeks after radical prostatectomy.<br>|
| Sham Comparator: Sham<br>Sham group receives five sessions of sham low intensity extracorporeal shockwave treatment, once per week for five consecutive weeks. Treatment is initiated three weeks after radical prostatectomy and is given using DUOLITH® SD1 manufactured by STORZ MEDICAL AG with a shockwave absorbing adapter. | Device: Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)<br>* Five sessions of penile Low Intensity Extracorporeal Shockwave Therapy initiated three weeks after radical prostatectomy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IIEF-5 Score 1 | Change in International Index of Erectile Function (IIEF-5) score compared to baseline | One month after final treatment session | 
| IIEF-5 Score 3 | Change in International Index of Erectile Function (IIEF-5) score compared to baseline | Three months after final treatment session | 
| IIEF-5 Score 6 | Change in International Index of Erectile Function (IIEF-5) score compared to baseline | Six months after final treatment session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EDITS | Erectile Dysfunction Inventory of Treatment Satisfaction score | One month after final treatment session | 
| RigiScan | Change in nocturnal erections compared to baseline | One month after final treatment session | 
| EHS 1 | Change in Erection Hardness Score compared to baseline | One month after final treatment session | 
| EHS 3 | Change in Erection Hardness Score compared to baseline | Three months after final treatment session | 
| EHS 6 | Change in Erection Hardness Score compared to baseline | Six months after final treatment session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radical Prostatectomy, Prostatectomy, Nerve-sparing, Non nerve-sparing, Erectile dysfunction, Erectile function, Shockwave, LI-ESWT, ESWT, Low intensity extracorporeal shockwave therapy, extracorporeal shockwave therapy