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Clinical Trials/NCT04059341
NCT04059341
Unknown
Not Applicable

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

Odense University Hospital1 site in 1 country70 target enrollmentSeptember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Erectile Dysfunction
Sponsor
Odense University Hospital
Enrollment
70
Locations
1
Primary Endpoint
IIEF-5 Score 6
Last Updated
6 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
July 1, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lars Lund,MD

Professor

Odense University Hospital

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.

Outcomes

Primary Outcomes

IIEF-5 Score 6

Time Frame: Six months after final treatment session

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

IIEF-5 Score 3

Time Frame: Three months after final treatment session

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

IIEF-5 Score 1

Time Frame: One month after final treatment session

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

Secondary Outcomes

  • RigiScan(One month after final treatment session)
  • EDITS(One month after final treatment session)
  • EHS 6(Six months after final treatment session)
  • EHS 1(One month after final treatment session)
  • EHS 3(Three months after final treatment session)

Study Sites (1)

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