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

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).

Study Overview

• Status: Unknown
• Conditions: Erectile Dysfunction; Radical Prostatectomy; Extracorporeal Shockwave Therapy
• Intervention / Treatment: Device: Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ali Moumneh, BSC.med; Phone Number: +45234826423; Email: almou15@student.sdu.dk
• Study Contact Backup: Name: Lars Lund, Professor; Email: lars.lund@rsyd.dk

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Odense University Hospital
    • Contact: Ali Moumneh, BSc.med; Email: almou15@student.sdu.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active 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.	Device: Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT); Five sessions of penile Low Intensity Extracorporeal Shockwave Therapy initiated three weeks after radical prostatectomy.
Sham Comparator: Sham; 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.	Device: Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT); Five sessions of penile Low Intensity Extracorporeal Shockwave Therapy initiated three weeks after radical prostatectomy.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Odense University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (Actual): August 16, 2019

Study Record Updates

• Last Update Posted (Actual): August 16, 2019
• Last Update Submitted That Met QC Criteria: August 15, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Prostatectomy; Erectile dysfunction; Radical Prostatectomy; LI-ESWT; ESWT; Shockwave; Erectile function; extracorporeal shockwave therapy; Nerve-sparing; Non nerve-sparing; Low intensity extracorporeal shockwave therapy
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: ELIESWTEDRP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No