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

Odense University Hospital

Status: Unknown

Conditions: Erectile Dysfunction; Radical Prostatectomy; Extracorporeal Shockwave Therapy

Treatments: Device: Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04059341

ELIESWTEDRP

Details and patient eligibility

About

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).

Enrollment: 70 estimated patients

Sex: Male

Ages: 20 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

70 participants in 2 patient groups

Active LI-ESWT

Experimental group

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.

Treatment:

Device: Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)

Sham

Sham Comparator group

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.

Treatment:

Device: Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)