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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care + sham ESWT | Sham Comparator | Cialis and Vacuum pump + sham Extra-corporeal shockwave therapy (ESWT) |
|
| Standard care + active ESWT | Active Comparator | Cialis and Vacuum pump + active Extra-corporeal shockwave therapy (ESWT) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extra-corporeal shockwave therapy (ESWT) | Device | low-intensity extra-corporeal shockwave therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Penile length | Clinical measurement of change in stretched flaccid penile length from baseline and time points to 12 months | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tet Yap, FRCS (Urol) | Contact | 07748182772 | tet.yap@gstt.nhs.uk | |
| Findlay MacAskill, MRCS | Contact | 07748182772 | findlay.macaskill@gstt.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Tet Yap, FRCS (Urol) | Guy's and St Thomas' NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guy's and St Thomas' NHS Trust | Recruiting | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29396020 | Background | Kalyvianakis D, Memmos E, Mykoniatis I, Kapoteli P, Memmos D, Hatzichristou D. Low-Intensity Shockwave Therapy for Erectile Dysfunction: A Randomized Clinical Trial Comparing 2 Treatment Protocols and the Impact of Repeating Treatment. J Sex Med. 2018 Mar;15(3):334-345. doi: 10.1016/j.jsxm.2018.01.003. Epub 2018 Feb 1. |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Randomised controlled trial
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Masking of probe applicator at device manufacturer before ESWT use
| Standard care | Other | Cialis and vacuum pump |
|
| 12 months |
| Adverse Events | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | 12 months |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |