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

  • STATUS
    Recruiting
  • End date
    Aug 1, 2023
  • participants needed
    100
  • sponsor
    Guy's and St Thomas' NHS Foundation Trust
Updated on 30 August 2021

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.

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.

Details
Condition Erectile Dysfunction Following Radical Prostatectomy
Treatment Standard Care, Extra-Corporeal Shockwave Therapy (ESWT)
Clinical Study IdentifierNCT03862599
SponsorGuy's and St Thomas' NHS Foundation Trust
Last Modified on30 August 2021

Eligibility

Yes No Not Sure

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
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