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

Launched by GUY'S AND ST THOMAS' NHS FOUNDATION TRUST · Mar 2, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the effects of low-intensity shockwave therapy on erectile dysfunction (ED) in men who have had surgery for prostate cancer, specifically radical prostatectomy. Erectile dysfunction can affect up to 85% of men after this type of surgery, and while some early research suggests that this therapy may help improve sexual performance, we still need to find out the best treatment dosage and duration. The trial aims to assess both the effectiveness and safety of this therapy for men dealing with ED after prostate surgery.

To participate in this study, men aged 40 to 65 who have been diagnosed with low or intermediate-risk prostate cancer may be eligible. Key requirements include having a specific cancer stage and score, being sexually active, and not experiencing urinary incontinence before surgery. Participants will receive treatment and complete questionnaires to help researchers evaluate the therapy’s impact. It’s important to note that certain medical conditions, such as anatomical abnormalities or complications from the surgery, may disqualify some individuals from joining the trial. If you meet the criteria and are interested, this could be an opportunity to contribute to important research that may help many men in the future.

Gender

MALE

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