Erectile FunctionESWTNCT03143790
Ekstracorporal Shock Wave Therapy as a Treatment for Erectile Dysfunction in Men After Prostatectomy
A study testing Extracorporeal Shockwave Terapy in people with Erectile Function, run by Odense University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Erectile Function
- What is being tested?
- Extracorporeal Shockwave Terapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Erectil dysfunction after radical prostatectomy less than two years ago
- IIEF - less than 20
- EHS - less than 4
Who cannot join
- drop out
- not sexual active
- penile prostesis
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Erectile Function
- Being tested
- Extracorporeal Shockwave Terapy
- Keywords
- Erectile Function, Prostatectomy, Extracorporeal Shock Wave Therapy, IIEF-5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shockwave TerapyProcedure or surgery
Also called ESWT
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
| Study group | Role | What they receive |
|---|---|---|
| ESWT | Active comparator | 500 shockwave 3 different points on penis bilateral Receives: Procedure: Extracorporeal Shockwave Terapy |
| Placebo | Placebo comparator | 500 shockwave 3 different points on penis bilateral Receives: Procedure: Extracorporeal Shockwave Terapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
IIEF-5 point
Change in IIEF-5 point
Measured: 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2017
- Study startAug 2014
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Capacity problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile FunctionStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization to active or placebo treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha Haahr M.D, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03143790
- Sponsor's protocol ID
- OUHL14.1
- Acronym
- ESWT
- Status last verified
- May 2017
- First submitted
- 7 Aug 2014
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All results will be published
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ekstracorporal Shock Wave Therapy as a Treatment for Erectile Dysfunction in Men After Prostatectomy
- ClinicalTrials.gov ID
- NCT03143790
- Acronym / sponsor ID
- ESWT / OUHL14.1
- Conditions
- Erectile Function
- Keywords
- Erectile Function, Prostatectomy, Extracorporeal Shock Wave Therapy, IIEF-5
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Capacity problems
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization to active or placebo treatment.
| Arm | Type | Receives |
|---|---|---|
| ESWT | Active comparator | Procedure: Extracorporeal Shockwave Terapy500 shockwave 3 different points on penis bilateral |
| Placebo | Placebo comparator | Procedure: Extracorporeal Shockwave Terapy500 shockwave 3 different points on penis bilateral |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Erectil dysfunction after radical prostatectomy less than two years ago
- IIEF - less than 20
- EHS - less than 4
Key exclusion criteria (3 listed)
- drop out
- not sexual active
- penile prostesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shockwave TerapyAlso: ESWTIntervention 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 | Procedure or surgery | ESWT, Placebo |
Primary outcome
IIEF-5 point
Time frame: 1, 3 and 6 months
Change in IIEF-5 point
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Individual participant dataSharing planned: No. All results will be published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shockwave Terapy in people with Erectile Function, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IIEF-5 point (time frame: 1, 3 and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.