Erectile Dysfunction Following Radical Prostatectomy
Conditions
Keywords
erectile dysfunction, shockwave, treatment, prostatectomy
Brief 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.
Detailed 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.
Interventions
low-intensity extra-corporeal shockwave therapy
OTHERStandard care
Cialis and vacuum pump
Sponsors
Guy's and St Thomas' NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Masking of probe applicator at device manufacturer before ESWT use
Intervention model description
Randomised controlled trial
Eligibility
Sex/Gender
MALE
Age
40 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sexual Function | 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Penile length | 12 months | Clinical measurement of change in stretched flaccid penile length from baseline and time points to 12 months |
| Urinary Incontinence | 12 months | Measurement of average change in EPIC questionnaire from baseline (pre-RP) to 24 week-FU and time points to 12 months |
| Adverse Events | 12 months | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 |
Countries
United Kingdom
Contacts
Primary ContactTet Yap, FRCS (Urol)
Backup ContactFindlay MacAskill, MRCS
Outcome results
None listed