An interventional study of Extra-corporeal shockwave therapy (ESWT) and Standard care in Erectile Dysfunction Following Radical Prostatectomy, sponsored by Guy's and St Thomas' NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to male participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-07.
Sponsored by Guy's and St Thomas' NHS Foundation Trust · Not applicable, Interventional, and Treatment
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.
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.
683 studies on the registry are indexed under Erectile Dysfunction; 117 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 542 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 284 studies on the registry; 79 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cialis and Vacuum pump + sham Extra-corporeal shockwave therapy (ESWT)
Device: Extra-corporeal shockwave therapy (ESWT) · Other: Standard care
Cialis and Vacuum pump + active Extra-corporeal shockwave therapy (ESWT)
Device: Extra-corporeal shockwave therapy (ESWT) · Other: Standard care
low-intensity extra-corporeal shockwave therapy
Cialis and vacuum pump
Sexual Function
Measurement of average change in IIEF-ED from baseline (pre-RP) to 24 week-FU 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction 5 being the worst outcome
Time frame: 6 months
Penile length
Clinical measurement of change in stretched flaccid penile length from baseline and time points to 12 months
Time frame: 12 months
Urinary Incontinence
Measurement of average change in EPIC questionnaire from baseline (pre-RP) to 24 week-FU and time points to 12 months
Time frame: 12 months
Adverse Events
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: 12 months
Plan to share: No
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Guy's and St Thomas' NHS Foundation Trust