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Low-energy Extracorporeal Shockwave Treatment for Patients After Radical Prostatectomy

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ClinicalTrials.gov Identifier: NCT03192917
Recruitment Status : Not yet recruiting
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Peter Bill Ladegaard, University of Southern Denmark

Brief 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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Post-Op Complication Prostatic Diseases Procedure: Low intensity extracorporeal shock wave treatment (LI-ESWT) Procedure: Low intensity extracorporeal shock wave treatment (LI-ESWT) sham Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Study Whether Low-energy Extracorporeal Shockwave Therapy (LI-ESWT) Can Increase Erectile Function in Patients After Radical Prostatectomy
Estimated Study Start Date : September 1, 2017
Estimated Primary Completion Date : November 1, 2017
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: Active treatment
This group of participant will receive low intensity shock wave treatment accounted on their penile shaft once every week for 5 weeks.
Procedure: Low intensity extracorporeal shock wave treatment (LI-ESWT)
Shock wave treatment with 3000 Hz for 10 min on the penile shaft. This will be done one time a week for five weeks.
Other Names:
  • Storz Medical AG
  • DUOLITH® SD1

Placebo Comparator: Placebo group
this group of participant will meet up for treatment. The treatment given will be the exact same as the active group, but the transducer used for shock wave treat will me capped, meaning that no shock waves are transmitted to their penis.
Procedure: Low intensity extracorporeal shock wave treatment (LI-ESWT) sham
A specialized cap can be applied to the chock wave device, which disallow shock waves to transmit through the unit.
Other Name: DUOLITH® SD1 with cap




Primary Outcome Measures :
  1. Erection hardness score (EHS) Baseline [ Time Frame: 2 weeks prior first treatment ]
    A five entity questionnaire to review the self-esteem of erection during sexual intercourse. The questionnaire will be mailed to the participants home adresses together with a return envelope.

  2. Erection hardness score first follow up [ Time Frame: 5 weeks after last treatment ]
    A five entity questionnaire to review the self-esteem of erection during sexual intercourse. The questionnaire will be mailed to the participants home adresses together with a return envelope.

  3. Erection hardness score second follow up [ Time Frame: 12 weeks after last treatment ]
    A five entity questionnaire to review the self-esteem of erection during sexual intercourse. The questionnaire will be mailed to the participants home adresses together with a return envelope.

  4. Erection hardness score third follow up [ Time Frame: 24 weeks after last treatment. ]
    A five entity questionnaire to review the self-esteem of erection during sexual intercourse. The questionnaire will be mailed to the participants home adresses together with a return envelope.


Secondary Outcome Measures :
  1. The International index of erection function (IIEF-5) baseline [ Time Frame: 2 weeks prior first treatment ]
    A fifteen item questionnaires to access data on erection function. Only question 1-5 will be used in for data interpretation. These item is also called til erection function domain (EF domain)

  2. The International index of erection function (IIEF-5) first follow up [ Time Frame: 5 weeks after last treatment ]
    A fifteen item questionnaires to access data on erection function. Only question 1-5 will be used in for data interpretation. These item is also called til erection function domain (EF domain)

  3. The International index of erection function (IIEF-5) second follow up [ Time Frame: 12 weeks after last treatment ]
    A fifteen item questionnaires to access data on erection function. Only question 1-5 will be used in for data interpretation. These item is also called til erection function domain (EF domain)

  4. The International index of erection function (IIEF-5) third follow up [ Time Frame: 24 weeks after last treatment ]
    A fifteen item questionnaires to access data on erection function. Only question 1-5 will be used in for data interpretation. These item is also called til erection function domain (EF domain)


Other Outcome Measures:
  1. Danish Prostate Symptoms Scoring scheme (DAN-PSS) [ Time Frame: 2 weeks prior first treatment ]
    A 12 item questionsaires regarding lower urinary tracts symptoms. Used to access whether there is any additional effects of the treatment

  2. Danish Prostate Symptoms Scoring scheme (DAN-PSS) [ Time Frame: 24 weeks after last treatment ]
    A 12 item questionsaires regarding lower urinary tracts symptoms. Used to access whether there is any additional effects of the treatment

  3. Pain sensation [ Time Frame: first treatment ]
    All participants are asked by the investigator, shortly after treatment, if there were any pain sensations during the application of shockwaves. This will be notified on a scheme.

  4. Pain sensation [ Time Frame: second treatment (1 week after first treatment) ]
    All participants are asked by the investigator, shortly after treatment, if there were any pain sensations during the application of shockwaves. This will be notified on a scheme.

  5. Pain sensation [ Time Frame: third treatment (2 week after first treatment) ]
    All participants are asked by the investigator, shortly after treatment, if there were any pain sensations during the application of shockwaves. This will be notified on a scheme.

  6. Pain sensation [ Time Frame: fourth treatment (3 week after first treatment) ]
    All participants are asked by the investigator, shortly after treatment, if there were any pain sensations during the application of shockwaves. This will be notified on a scheme.

  7. Pain sensation [ Time Frame: fifth treatment (4 week after first treatment) ]
    All participants are asked by the investigator, shortly after treatment, if there were any pain sensations during the application of shockwaves. This will be notified on a scheme.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only men undergone a surgery for prostatectomy will be included in this trial.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Erectile dysfunction for more than 6 months,
  • Time since prostatectomy must be at least 9 month
  • At least unilateral nerve-sparing RP.
  • Erection Hardness Score (EHS) less than 2 and an Index of Erectile Function (IIEF-5) score less than 17
  • Age 20-80 years
  • have been in a relationship for more than 3 months.
  • Participant can give informed consent.

Exclusion Criteria:

  • Men with ED due to other reason than RD (psychogenic, neurological pathology or organic ED etc.)
  • Rectal extirpation, radiation therapy to the pelvic area and recovery from any other cancer within the past 5 years are excluded.
  • Participants with heart disease prohibiting sexual activity or taking medication with antiandrogens, anticoagulant (apart from aspirin) or systemic use of glucocorticoids within 5 weeks.
  • ED treatment within the last 7 days (screening phase), oral medication, vacuum devices, injections.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192917


Contacts
Contact: Peter Bill Ladegaard, Student +45 40189418 pelad12@student.sdu.dk
Contact: Peter Bill Ladegaard petee.bill@gmail.com

Locations
Denmark
Odense University Hospital (OUH)
Odense, Fyn, Denmark, 5230
Sponsors and Collaborators
University of Southern Denmark
Investigators
Study Chair: Lars Lund, MD professor Department of Urology

Responsible Party: Peter Bill Ladegaard, Student, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03192917     History of Changes
Other Study ID Numbers: S-20170074
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peter Bill Ladegaard, University of Southern Denmark:
Shock wave therapy
erectile dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Prostatic Diseases
Postoperative Complications
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Pathologic Processes