Low-energy Extracorporeal Shockwave Treatment for Patients After Radical Prostatectomy
Condition: Erectile Dysfunction; Post-Op Complication; Prostatic Diseases
MeSH terms: Erectile Dysfunction; Prostatic Diseases; Postoperative Complications
Study type: Interventional

Summary: 
      The purpose of this project is to verify the relationship between low intensity shock wave
      treatment (LI-SWT) and increased scores in self-assessment regarding to erectile function
      (ED) and sexual intercourse, in patients, who has undergone a radical prostatectomy (RP). The
      data will be obtained from patients using international accepted sexual questionnaires prior
      to the LI-SWT and 5, 12 and 24 weeks following treatment.
    

Detailed description: 
      Extracorporeal shockwave therapy (ESWT) has been used for many years in different fields. In
      1980, the clinical use of extracorporeal shockwave lithotripsy as a treatment for stone
      disease in the upper urinary tract began and proved effective. Throughout the years, ESWT has
      been modified for use in other specialties, such as in the treatment of gallstones,
      sialolithiasis and Peyronie's disease. Animal studies have demonstrated neoangiogenesis in
      myocardial tissue and skin flaps as well as regeneration of nervous tissue. Gotte et al.
      found that shock waves can, under suitable conditions, lead to non-catalytic synthesis of
      physiologically relevant quantities of NO. These pioneering findings corroborate our
      hypothesis that ED due to RP, can likely be treated by LI-SWT.

      It is well known that patients radically operated for prostate cancer subsequently develop
      erectile dysfunction (ED) and /or urinary incontinence. A meta-analysis from 2009 found that
      the overall erection recovery rate after prostatectomy were 58%, meaning that a certain
      amount of patients still suffer from ED in the postoperative lifespan.

      The investigators want to investigate in a randomized trial whether LI-ESWT is efficient in
      ED patients, who has undergone RP, regarding to sexual function. These data will be assessed
      by changes in outcome of sexual questionnaire regarding to sexual function and erection
      hardness. This hypothesis has previous been tested in a Danish pilot study. The study design
      was a prospective cohort study with 16 participants all suffering from ED due to nerve
      sparing RD. The participants received two series of LI-ESWT per week in a 3-week period. The
      results indicated a gradual increase in erectile function at the 1 month follow up, evaluated
      by cross matching the IIEF-15 scores before and after treatment. However, the effect was
      damped off at the last follow up one year later. The pilot study concluded that more research
      had to be done in a larger population group.

      The study design is decided to be a prospective, blinded, randomized placebo-control follow
      up design. The total enrol of participants are estimated to be sixty-four divided into a
      placebo group and an active group.

      The participants who meet the inclusions criteria (see section below) will be randomly
      assigned to either a control group (P) or an active group based (V) on a randomization list.

      The treatment sessions will take place at the outpatient clinic of the department of urology
      L, OUH. The shock wave device used for this study is a duolith® SD1 T-Top from Storz Medical
      (see fig. 2). The device is set at 0.15 mJ/mm2, 5 Hz, with a total of 3000 impulses, and a
      total energy of 12.8 J per treatment. LI-ESWT will be performed in six positions on the penis
      (distal, center and proximal part of each cavernous body) and given by a therapist educated
      for the purpose. The cap used to prevent LI-SWT in the placebo group will be positioned by
      the Head of the Department to ensure valid blinding.

      Prior to the treatment, the participants will be asked to fulfil questionnaires (EHS, IIEF-15
      and DAN-PSS) to assess data on lower urinary tract symptoms, sexual dysfunction and erection
      hardness. At the first treatment session (baseline function), the investigator reviews the
      questionnaires in cooperation with the participant to ensure no conflicts and
      misunderstanding in questions.

      There will be a total of 5 treatment sessions during a 5-week period. Shortly after
      treatment, the participants will be asked to fill in the questionnaires once again. The
      questionnaires will be mailed to the participants home addresses together with a prepaid
      return envelope and asked to be reposted at 5th, 12th and 24th week respectively.
    

Intervention name(s): Low intensity extracorporeal shock wave treatment (LI-ESWT); Low intensity extracorporeal shock wave treatment (LI-ESWT) sham
Intervention type(s): Procedure; Procedure
Intervention description(s): Shock wave treatment with 3000 Hz for 10 min on the penile shaft. This will be done one time a week for five weeks.; A specialized cap can be applied to the chock wave device, which disallow shock waves to transmit through the unit.
Other intervention name(s): Storz Medical AG; DUOLITH® SD1; DUOLITH® SD1 with cap
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Shock wave therapy; erectile dysfunction