Status:
UNKNOWN
Low Intensity Shock-wave Therapy (Li-ESWT) in Penile Rehabilitation After Radical Prostatectomy
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Erectile Dysfunction Following Radical Prostatectomy
Eligibility:
MALE
40-65 years
Phase:
NA
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 m...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03862599
Start Date
June 1 2021
End Date
May 1 2025
Last Update
March 7 2023
Active Locations (1)
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1
Guy's and St Thomas' NHS Trust
London, United Kingdom