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

Guy's and St Thomas' NHS Foundation Trust

Status: Enrolling

Conditions: Erectile Dysfunction Following Radical Prostatectomy

Treatments: Other: Standard care; Device: Extra-corporeal shockwave therapy (ESWT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03862599

250004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Standard care + sham ESWT

Sham Comparator group

Description:

Cialis and Vacuum pump + sham Extra-corporeal shockwave therapy (ESWT)

Treatment:

Device: Extra-corporeal shockwave therapy (ESWT)

Other: Standard care

Standard care + active ESWT

Active Comparator group

Description:

Cialis and Vacuum pump + active Extra-corporeal shockwave therapy (ESWT)

Treatment:

Device: Extra-corporeal shockwave therapy (ESWT)

Other: Standard care