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

Last updated: March 6, 2023
Sponsor: Guy's and St Thomas' NHS Foundation Trust
Overall Status: Active - Recruiting

Phase

N/A

Condition

Male Hormonal Deficiencies/abnormalities

Impotence

Infertility

Treatment

N/A

Clinical Study ID

NCT03862599
250004
  • Ages 40-65
  • Male

Study 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.

Eligibility Criteria

Inclusion

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

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 deprivationtherapy
  • 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, asjudged by the principle investigator

Study Design

Total Participants: 100
Study Start date:
June 01, 2021
Estimated Completion Date:
May 01, 2025

Study 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.

Connect with a study center

  • Guy's and St Thomas' NHS Trust

    London,
    United Kingdom

    Active - Recruiting

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