Early Extracorporeal Shockwave Therapy for Erectile Dysfunction in Radically Prostatectomised Men.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Erectile Dysfunction
- Sponsor
- Odense University Hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- IIEF-5 Score 6
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this project is to assess the relationship between low intensity shock wave treatment (LI-SWT) and erectile function (ED) in patients who have undergone radical prostatectomy (RP).
Investigators
Lars Lund,MD
Professor
Odense University Hospital
Eligibility Criteria
Inclusion Criteria
- •Radically prostatectomised men
- •Non nerve-sparing or nerve-sparing RP.
- •Age 20-80 years
- •Have been in a relationship for more than 3 months.
- •Sexually active
- •Patient can give informed consent.
Exclusion Criteria
- •Men with ED of neuropathological or psychogenic origin
- •Rectal extirpation, radiation therapy to the pelvic area and recovery from any other cancer within the past 5 years are excluded.
- •Patients with heart disease prohibiting sexual activity or taking medication with antiandrogens, anticoagulant (apart from aspirin) or systemic use of glucocorticoids within 5 weeks.
Outcomes
Primary Outcomes
IIEF-5 Score 6
Time Frame: Six months after final treatment session
Change in International Index of Erectile Function (IIEF-5) score compared to baseline
IIEF-5 Score 3
Time Frame: Three months after final treatment session
Change in International Index of Erectile Function (IIEF-5) score compared to baseline
IIEF-5 Score 1
Time Frame: One month after final treatment session
Change in International Index of Erectile Function (IIEF-5) score compared to baseline
Secondary Outcomes
- RigiScan(One month after final treatment session)
- EDITS(One month after final treatment session)
- EHS 6(Six months after final treatment session)
- EHS 1(One month after final treatment session)
- EHS 3(Three months after final treatment session)