An interventional study of Low intensity extracorporeal shock wave treatment (LI-ESWT) and Low intensity extracorporeal shock wave treatment (LI-ESWT) sham in Erectile Dysfunction, Post-Op Complication and Prostatic Diseases, sponsored by University of Southern Denmark. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-02.
Sponsored by University of Southern Denmark · Not applicable, Interventional, and Treatment
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.
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.
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's enrollment of 38 is below the median of 70 across 551 interventional studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →University of Southern Denmark is the lead sponsor of 336 studies on the registry; 46 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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
Shock wave treatment with 3000 Hz for 10 min on the penile shaft. This will be done one time a week for five weeks.
Also known as: Storz Medical AG, DUOLITH® SD1
A specialized cap can be applied to the chock wave device, which disallow shock waves to transmit through the unit.
Also known as: DUOLITH® SD1 with cap
Erection hardness score (EHS) Baseline
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.
Time frame: 2 weeks prior first treatment
Erection hardness score first follow up
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.
Time frame: 5 weeks after last treatment
Erection hardness score second follow up
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.
Time frame: 12 weeks after last treatment
Erection hardness score third follow up
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.
Time frame: 24 weeks after last treatment.
The International index of erection function (IIEF-5) baseline
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)
Time frame: 2 weeks prior first treatment
The International index of erection function (IIEF-5) first follow up
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)
Time frame: 5 weeks after last treatment
The International index of erection function (IIEF-5) second follow up
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)
Time frame: 12 weeks after last treatment
The International index of erection function (IIEF-5) third follow up
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)
Time frame: 24 weeks after last treatment
Danish Prostate Symptoms Scoring scheme (DAN-PSS)
A 12 item questionsaires regarding lower urinary tracts symptoms. Used to access whether there is any additional effects of the treatment
Time frame: 2 weeks prior first treatment
Danish Prostate Symptoms Scoring scheme (DAN-PSS)
A 12 item questionsaires regarding lower urinary tracts symptoms. Used to access whether there is any additional effects of the treatment
Time frame: 24 weeks after last treatment
Pain sensation
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.
Time frame: first treatment
Pain sensation
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.
Time frame: second treatment (1 week after first treatment)
Pain sensation
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.
Time frame: third treatment (2 week after first treatment)
Pain sensation
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.
Time frame: fourth treatment (3 week after first treatment)
Pain sensation
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.
Time frame: fifth treatment (4 week after first treatment)
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Aug 2018, 9 months.
Of 115 non-industry interventional studies with no phase under Erectile Dysfunction, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's 9 months is below that.
Counting every sponsor, half of 137 studies reached it within 32 months; a quarter within 14 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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