Low Intensity Extracorporeal Shock-wave Therapy (Li-ESWT) in Penile Rehabilitation After Radical Prostatectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Erectile Dysfunction Following Radical Prostatectomy
- Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Sexual Function
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Tet Yap
Principal Investigator
Guy's and St Thomas' NHS Foundation Trust
Eligibility Criteria
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
Outcomes
Primary Outcomes
Sexual Function
Time Frame: 6 months
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
Secondary Outcomes
- Urinary Incontinence(12 months)
- Adverse Events(12 months)
- Penile length(12 months)