Erectile Function
Conditions
Keywords
Erectile Function, Prostatectomy, Extracorporeal Shock Wave Therapy, IIEF-5
Brief summary
Extra Corporal Shock wave Therapy Has proven effective as treatment with mild to moderate erectile dysfunction in men with erectile dysfunction. Investigator will examine whether the treatment also applies to men with moderate to severe erectile dysfunction after nerve injury associated with prostatectomy.
Detailed description
All patients have undergone prostatectomy and are without recurrence. None of the men have sufficient effect of medical treatment for erectile dysfunction (tablets or injection therapy). Each participant will fill out two validated sexual function questionnaires: IIEF-5 (International Index of Erectile Function), and EHS (Erection Hardness Score). Our treatment protocol consists of one treatment sessions per week for 5 wk. The shockwaves are delivered to the distal, mid, and proximal penile shaft, and the left and right crura. The duration of each LI-ESWT session was about 20min, and each session comprised 500 shocks per treatment point (3000 per session) at an energy density of 0.15 mJ/mm2. Patients are randomized to active treatment or placebo.By placebo added a blocking membrane in the machine, handling is carried out exactly the same way as the active treatment. None of the attending staff members will be familiar with who receive active and who receive placebo treatment. For evaluation, the International index of erectile function (IIEF-5) will be used after 1, 3- and 6-mo follow-up.
Interventions
PROCEDUREExtracorporeal Shockwave Terapy
Intervention is treatment with ESWT. Placebo treatment is using the same device as the active treatment, but the shock waves stopped in a non pressure-conductive filter
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Patient and therapist are blind. Primary investigator is not blind. Unblinding occurs 3 months after the end of treatment
Intervention model description
Randomization to active or placebo treatment.
Eligibility
Sex/Gender
MALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Erectil dysfunction after radical prostatectomy less than two years ago * IIEF - less than 20 * EHS - less than 4
Exclusion criteria
* drop out * not sexual active * penile prostesis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IIEF-5 point | 1, 3 and 6 months | Change in IIEF-5 point |
Countries
Denmark
Outcome results
None listed