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

Sponsor

Odense University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04059341

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Erectile Dysfunction Extracorporeal Shockwave Therapy Radical Prostatectomy	Device: Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomised, single-blinded, placebo-controlled trialRandomised, single-blinded, placebo-controlled trial

Masking:

Single (Participant)

Masking Description:

Sham LI-ESWT treatment.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2019

Anticipated Primary Completion Date :

Jan 1, 2020

Anticipated Study Completion Date :

Jul 1, 2020

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

IIEF-5 Score 1 [One month after final treatment session]
Change in International Index of Erectile Function (IIEF-5) score compared to baseline
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

Secondary Outcome Measures

EDITS [One month after final treatment session]
Erectile Dysfunction Inventory of Treatment Satisfaction score
RigiScan [One month after final treatment session]
Change in nocturnal erections 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
EHS 6 [Six months after final treatment session]
Change in Erection Hardness Score compared to baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.