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

NCT04059341 | Unknown DMC

• 1 other identifier: ELIESWTEDRP
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Erectile Dysfunction; Extracorporeal Shockwave Therapy; Radical Prostatectomy

Keywords

Radical Prostatectomy; Prostatectomy; Nerve-sparing; Non nerve-sparing; Erectile dysfunction; Erectile function; Shockwave; LI-ESWT; ESWT; Low intensity extracorporeal shockwave therapy; extracorporeal shockwave therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• EDITS

  One month after final treatment session

• RigiScan

  One month after final treatment session

• EHS 1

  One month after final treatment session

• EHS 3

  Three months after final treatment session

• EHS 6

  Six months after final treatment session

Study Arms (2)

Active LI-ESWT

EXPERIMENTAL

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)

Sham

SHAM COMPARATOR

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)

Interventions

Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT) DEVICE

Five sessions of penile Low Intensity Extracorporeal Shockwave Therapy initiated three weeks after radical prostatectomy.

Active LI-ESWT; Sham

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Ali Moumneh, BSC.med

CONTACT

+45234826423; almou15@student.sdu.dk

Lars Lund, Professor

CONTACT

lars.lund@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Sham LI-ESWT treatment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomised, single-blinded, placebo-controlled trial

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 16, 2019
• Study Start: September 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 16, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)