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

Primary Purpose

Erectile Dysfunction, Extracorporeal Shockwave Therapy, Radical Prostatectomy

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Erectile Dysfunction focused on measuring Radical Prostatectomy, Prostatectomy, Nerve-sparing, Non nerve-sparing, Erectile dysfunction, Erectile function, Shockwave, LI-ESWT, ESWT, Low intensity extracorporeal shockwave therapy, extracorporeal shockwave therapy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active LI-ESWT

Sham

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

IIEF-5 Score 1
Change in International Index of Erectile Function (IIEF-5) score compared to baseline
IIEF-5 Score 3
Change in International Index of Erectile Function (IIEF-5) score compared to baseline
IIEF-5 Score 6
Change in International Index of Erectile Function (IIEF-5) score compared to baseline

Secondary Outcome Measures

EDITS
Erectile Dysfunction Inventory of Treatment Satisfaction score
RigiScan
Change in nocturnal erections compared to baseline
EHS 1
Change in Erection Hardness Score compared to baseline
EHS 3
Change in Erection Hardness Score compared to baseline
EHS 6
Change in Erection Hardness Score compared to baseline

Full Information

First Posted
August 15, 2019
Last Updated
August 15, 2019
Sponsor
Odense University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04059341
Brief Title
Early Extracorporeal Shockwave Therapy for Erectile Dysfunction in Radically Prostatectomised Men.
Official Title
Early Extracorporeal Shockwave Therapy for Erectile Dysfunction in Radically Prostatectomised Men.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised, single-blinded, placebo-controlled trial
Masking
Participant
Masking Description
Sham LI-ESWT treatment.
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active LI-ESWT
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)
Intervention Description
Five sessions of penile Low Intensity Extracorporeal Shockwave Therapy initiated three weeks after radical prostatectomy.
Primary Outcome Measure Information:
Title
IIEF-5 Score 1
Description
Change in International Index of Erectile Function (IIEF-5) score compared to baseline
Time Frame
One month after final treatment session
Title
IIEF-5 Score 3
Description
Change in International Index of Erectile Function (IIEF-5) score compared to baseline
Time Frame
Three months after final treatment session
Title
IIEF-5 Score 6
Description
Change in International Index of Erectile Function (IIEF-5) score compared to baseline
Time Frame
Six months after final treatment session
Secondary Outcome Measure Information:
Title
EDITS
Description
Erectile Dysfunction Inventory of Treatment Satisfaction score
Time Frame
One month after final treatment session
Title
RigiScan
Description
Change in nocturnal erections compared to baseline
Time Frame
One month after final treatment session
Title
EHS 1
Description
Change in Erection Hardness Score compared to baseline
Time Frame
One month after final treatment session
Title
EHS 3
Description
Change in Erection Hardness Score compared to baseline
Time Frame
Three months after final treatment session
Title
EHS 6
Description
Change in Erection Hardness Score compared to baseline
Time Frame
Six months after final treatment session

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Moumneh, BSC.med
Phone
+45234826423
Email
almou15@student.sdu.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Lund, Professor
Email
lars.lund@rsyd.dk
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Moumneh, BSc.med
Email
almou15@student.sdu.dk

12. IPD Sharing Statement

Plan to Share IPD
No

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

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