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

NCT ID: NCT04059341

Last Updated: 2019-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2020-07-01

Brief Summary

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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).

Detailed Description

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Conditions

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Erectile Dysfunction Extracorporeal Shockwave Therapy Radical Prostatectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised, single-blinded, placebo-controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
Sham LI-ESWT treatment.

Study Groups

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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.

Group Type EXPERIMENTAL

Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)

Intervention Type DEVICE

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

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.

Group Type SHAM_COMPARATOR

Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)

Intervention Type DEVICE

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

Interventions

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Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lars Lund,MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

Central Contacts

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Ali Moumneh, BSC.med

Role: CONTACT

+45234826423

Lars Lund, Professor

Role: CONTACT

Facility Contacts

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Ali Moumneh, BSc.med

Role: primary

Other Identifiers

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ELIESWTEDRP

Identifier Type: -

Identifier Source: org_study_id

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