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

Erectile Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04059341
• Other study ID #: ELIESWTEDRP
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: August 2019
• Source: Odense University Hospital
• Contact: Ali Moumneh, BSC.med
• Phone: +45234826423
• Email: almou15[@]student.sdu.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: July 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Extracorporeal Shockwave Therapy
• Radical Prostatectomy

Intervention

Device:
• Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)
Five sessions of penile Low Intensity Extracorporeal Shockwave Therapy initiated three weeks after radical prostatectomy.

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IIEF-5 Score 1	Change in International Index of Erectile Function (IIEF-5) score compared to baseline	One month after final treatment session
Primary	IIEF-5 Score 3	Change in International Index of Erectile Function (IIEF-5) score compared to baseline	Three months after final treatment session
Primary	IIEF-5 Score 6	Change in International Index of Erectile Function (IIEF-5) score compared to baseline	Six months after final treatment session
Secondary	EDITS	Erectile Dysfunction Inventory of Treatment Satisfaction score	One month after final treatment session
Secondary	RigiScan	Change in nocturnal erections compared to baseline	One month after final treatment session
Secondary	EHS 1	Change in Erection Hardness Score compared to baseline	One month after final treatment session
Secondary	EHS 3	Change in Erection Hardness Score compared to baseline	Three months after final treatment session
Secondary	EHS 6	Change in Erection Hardness Score compared to baseline	Six months after final treatment session