Low Intensity Shock-wave Therapy (Li-ESWT) in Penile Rehabilitation After Radical Prostatectomy

Study Overview
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Brief Summary
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Erectile dysfunction (ED) is reported in up to 85% of men who have undergone a radical prostatectomy for prostate cancer. A few small studies have recently shown that low-intensity shockwave therapy may improve sexual performance in men with ED. However, the optimal dosage and length of treatment is yet to be determined. The investigators propose a randomised trial evaluating the efficacy and safety of low-intensity shockwave therapy in men with ED following prostatectomy surgery.

Detailed Description
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Erectile dysfunction (ED) is reported in up to 85% of men who have undergone a radical prostatectomy for prostate cancer. At present, this debilitating consequence of surgery is managed in a step-wise approach including oral medication, injections and in severe cases, insertion of a penile prosthesis. A few small studies have shown that low-intensity shockwave therapy may improve sexual performance in men with ED. However, the optimal dosage and length of treatment is yet to be determined. The investigators propose a randomised trial evaluating the efficacy and safety of low-intensity shockwave therapy in men with ED following prostatectomy surgery. Low-intensity shockwave therapy would be a non-invasive treatment to preserve and improve patient's sexual function.

Official Title
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Low Intensity Extracorporeal Shock-wave Therapy (Li-ESWT) in Penile Rehabilitation After Radical Prostatectomy

Conditions
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Erectile Dysfunction Following Radical Prostatectomy

Intervention / Treatment
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* Device: Extra-corporeal shockwave therapy (ESWT)
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40 - 65 Diagnosed with low/intermediate-risk prostate cancer: PSA < 20 ng/ml Gleason score < 8 PCa stage =< T2b Baseline IIEF-ED 17-30 without erectogenic aids No pre-operative urinary incontinence (no usage of urinary pads) Sexually active Able to understand and complete patient questionnaires Consent to participate Exclusion Criteria: Anatomical abnormalities in the genitalia or pelvic region Post-RP complications that could impact safety or effectiveness of ESWT (eg. hematoma, fistula, unresolved anastomotic leak) Incomplete tumor removal (positive surgical margin) Tumor upstaging beyond T2b Nerve sparing score > 5 Previous or scheduled treatment with pelvic radiotherapy and/or androgen deprivation therapy Untreated hypogonadism (serum total testosterone < 300 mg/dL) Anti-coagulant medication, except acetylsalicyclic acid up to 100mg daily Any other condition that would prevent the patient from completing the study, as judged by the principle investigator

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Standard care + sham ESWT<br>Cialis and Vacuum pump + sham Extra-corporeal shockwave therapy (ESWT) | Device: Extra-corporeal shockwave therapy (ESWT)<br>* low-intensity extra-corporeal shockwave therapy<br>Other: Standard care<br>* Cialis and vacuum pump<br>|
| Active Comparator: Standard care + active ESWT<br>Cialis and Vacuum pump + active Extra-corporeal shockwave therapy (ESWT) | Device: Extra-corporeal shockwave therapy (ESWT)<br>* low-intensity extra-corporeal shockwave therapy<br>Other: Standard care<br>* Cialis and vacuum pump<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual Function | Measurement of average change in IIEF-ED from baseline (pre-RP) to 24 week-FU 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction 5 being the worst outcome | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Penile length | Clinical measurement of change in stretched flaccid penile length from baseline and time points to 12 months | 12 months | 
| Urinary Incontinence | Measurement of average change in EPIC questionnaire from baseline (pre-RP) to 24 week-FU and time points to 12 months | 12 months | 
| Adverse Events | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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erectile dysfunction, shockwave, treatment, prostatectomy