Early Extracorporeal Shockwave Therapy for Erectile Dysfunction in Radically Prostatectomised Men.

Not Applicable

• Conditions: Extracorporeal Shockwave Therapy; Radical Prostatectomy; Erectile Dysfunction
• Interventions: Device: Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)

• Registration Number: NCT04059341
• Lead Sponsor: Odense University Hospital

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-08
• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-15
• Last Update Submitted: 2019-08-15
• Study First Posted: 2019-08-16
• Last Update Posted: 2019-08-16
• Study Start: 2019-09-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 70

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)	Sham group receives five sessions of sham low intensity extracorporeal shockwave treatment, once per week for five consecutive weeks. Treatment is initiated three weeks after radical prostatectomy and is given using DUOLITH® SD1 manufactured by STORZ MEDICAL AG with a shockwave absorbing adapter.
Active LI-ESWT	Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)	Active group receives five sessions of low intensity extracorporeal shockwave treatment, once per week for five consecutive weeks. Treatment is initiated three weeks after radical prostatectomy and is given using DUOLITH® SD1 manufactured by STORZ MEDICAL AG.

Primary Outcome Measures

Name	Time	Method
IIEF-5 Score 3	Three months after final treatment session	Change in International Index of Erectile Function (IIEF-5) score compared to baseline
IIEF-5 Score 6	Six months after final treatment session	Change in International Index of Erectile Function (IIEF-5) score compared to baseline
IIEF-5 Score 1	One month after final treatment session	Change in International Index of Erectile Function (IIEF-5) score compared to baseline

Secondary Outcome Measures

Name	Time	Method
RigiScan	One month after final treatment session	Change in nocturnal erections compared to baseline
EDITS	One month after final treatment session	Erectile Dysfunction Inventory of Treatment Satisfaction score
EHS 6	Six months after final treatment session	Change in Erection Hardness Score compared to baseline
EHS 1	One month after final treatment session	Change in Erection Hardness Score compared to baseline
EHS 3	Three months after final treatment session	Change in Erection Hardness Score compared to baseline

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense, Denmark