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

Recruiting
40 - 65 years of age
Male
Phase N/A

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Overview

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.

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.

Eligibility

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

Study details

Erectile Dysfunction Following Radical Prostatectomy

NCT03862599

Guy's and St Thomas' NHS Foundation Trust

25 January 2024

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