Peyronie DiseaseNCT03530540
Low-Intensity Extracorporeal Shockwave Therapy and Vacuum Erectile Device as a Treatment for Peyronies Disease.
A study testing low-intensity extracorporeal shockwave therapy and Penile pump in people with Peyronie Disease, run by Odense University Hospital at 1 site in Denmark.
Trial summary
Aim The primary aim is to examine whether LI-ESWT and vacuum erectile device (VED) followed by manipulation exercises has beneficial effect on PD patients compared to a placebo group. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Peyronie Disease
- What is being tested?
- low-intensity extracorporeal shockwave therapy and Penile pump
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Mar 2018to 1 Feb 2020
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PD for more than 6 months
- Penile curve greater than 30 degrees and less than 90 degrees
- Age 18-80
- No previous penile surgery
- Informed consent
- Able to speak and understand Danish
Who cannot join
- Penile curve greater than 90 degrees
- Previous surgery for PD
- Patients undergoing other interventions for PD
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Odense university hospital
Odense, 5000
Lars Lund, Professor, 45 5140 8982, Lars.Lund@rsyd.dk
About this study
Official title: A Prospective Randomized Double Blinded Placebo Controlled Clinical Trial Evaluating the Combined Effect of Low-Intensity Extracorporeal Shockwave Therapy (LI-ESWT) and Vacuum Erectile Device Combined With Manipulation Exercises on Peyronies Disease.
Aim The primary aim is to examine whether LI-ESWT and vacuum erectile device (VED) followed by manipulation exercises has beneficial effect on PD patients compared to a placebo group.
Primary Outcome
Read more
- Peyronie's Disease Questionnaire (PDQ)
- Visual Analogue Scale score (VAS)
- International Index of Erectile Function 5 (IEFF-5)
- Penile curve measurements (gold standard) on pictures before and after treatment
- Plaque size
Method This study is designed as a prospective, randomized, double-blinded, placebo-controlled with follow-up after 1, 3 and 6 months.
A total of 50 participants who meets the inclusion criteria's will randomly be assigned to I(intervention) or C(control) group based on a randomization list which is retained in a sealed envelope. The content of the envelope is only familiar to the Head of the Department of Urology to ensure valid randomization.
All treatment sessions are executed at the outpatient clinic of the department of urology department L at Odense University Hospital(OUH). All patients receive treatment with the same device a Duolith® SD1 T-Top from Storz Medical. However, when treating patients in the control group the handpiece will be covered by a shockwave absorbent material. Settings and setup are identical in both groups to make sure that patients are unable to acknowledge which treatment is being performed.
- Conditions
- Peyronie Disease
- Being tested
- low-intensity extracorporeal shockwave therapy, Placebo LI-ESWT, Penile pump
- Medical subject headings
- Penile Induration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-intensity extracorporeal shockwave therapyDevice
Active shockwaves
Placebo LI-ESWTDevice
Placebo shockwaves
Penile pumpDevice
both groups will be treated with a penile pump
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Active shockwaves Receives: Device: low-intensity extracorporeal shockwave therapy; Device: Penile pump |
| Placebo | Placebo comparator | Placebo shockwaves Receives: Device: Placebo LI-ESWT; Device: Penile pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in penile curvature
Change in penile curvature from baseline to follow-up at 1,3 and 6 months. Penile curvature is measured on pictures submitted by the patient.
Measured: penile curve will be assessed at baseline, and 1,3 and 6 months.
Secondary outcomes (3)
Change in pain score using the Visual Analogue Scale (VAS)
VAS is a subjective pain score ranging from 0-10 whereas 0 means no pain, and 10 being excruciating pain. Patients are asked to rank their average pain for the last 24 hours.
Measured: VAS will be assessed at baseline, and 1,3 and 6 months.
Change in Erectile function using the International Index of Erectile Function 5 (IIEF-5).
Erectile function is estimated using the IIEF-5 which is a 5 item questionnaire. Based on the patients answers a final score is merged. The definition of erectile dysfunction(ED) is; 5-7 (severe), 8-11(moderate), 12-16(mild-moderate), 17-21(mild) and 22-25 no ED.
Measured: IIEF-5 will be assessed at baseline, and 1,3 and 6 months.
Change in Peyronies disease questionnaire score
Questionnaire to evaluate the psychological/physical consequences of peyronies disease.
Measured: Peyronies disease questionnaire will be assessed at baseline, and 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 posted21 May 2018
- Study start13 Mar 2018
- Primary completion1 Feb 2020 (estimated)
- Study completion1 Feb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peyronie DiseaseStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Lund,MD, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530540
- Sponsor's protocol ID
- 20170201
- Status last verified
- Mar 2019
- First submitted
- 7 May 2018
- Last updated
- 14 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Double Blinded Placebo Controlled Clinical Trial Evaluating the Combined Effect of Low-Intensity Extracorporeal Shockwave Therapy (LI-ESWT) and Vacuum Erectile Device Combined With Manipulation Exercises on Peyronies Disease.
- ClinicalTrials.gov ID
- NCT03530540
- Acronym / sponsor ID
- 20170201
- Conditions
- Peyronie Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 1 Feb 2020 (estimated)
- Study completion
- 1 Feb 2020 (estimated)
- First posted
- 21 May 2018 (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.
Aim The primary aim is to examine whether LI-ESWT and vacuum erectile device (VED) followed by manipulation exercises has beneficial effect on PD patients compared to a placebo group.
Primary Outcome
- Peyronie's Disease Questionnaire (PDQ)
- Visual Analogue Scale score (VAS)
- International Index of Erectile Function 5 (IEFF-5)
- Penile curve measurements (gold standard) on pictures before and after treatment
- Plaque size
Method This study is designed as a prospective, randomized, double-blinded, placebo-controlled with follow-up after 1, 3 and 6 months.
A total of 50 participants who meets the inclusion criteria's will randomly be assigned to I(intervention) or C(control) group based on a randomization list which is retained in a sealed envelope. The content of the envelope is only familiar to the Head of the Department of Urology to ensure valid randomization.
All treatment sessions are executed at the outpatient clinic of the department of urology department L at Odense University Hospital(OUH). All patients receive treatment with the same device a Duolith® SD1 T-Top from Storz Medical. However, when treating patients in the control group the handpiece will be covered by a shockwave absorbent material. Settings and setup are identical in both groups to make sure that patients are unable to acknowledge which treatment is being performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: low-intensity extracorporeal shockwave therapy, Device: Penile pumpActive shockwaves |
| Placebo | Placebo comparator | Device: Placebo LI-ESWT, Device: Penile pumpPlacebo shockwaves |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- PD for more than 6 months
- Penile curve greater than 30 degrees and less than 90 degrees
- Age 18-80
- No previous penile surgery
- Informed consent
Key exclusion criteria (3 listed)
- Penile curve greater than 90 degrees
- Previous surgery for PD
- Patients undergoing other interventions for PD
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 |
|---|---|---|
| low-intensity extracorporeal shockwave therapyActive shockwaves | Device | Intervention |
| Placebo LI-ESWTPlacebo shockwaves | Device | Placebo |
| Penile pumpboth groups will be treated with a penile pump | Device | Intervention, Placebo |
Primary outcome
Change in penile curvature
Time frame: penile curve will be assessed at baseline, and 1,3 and 6 months.
Change in penile curvature from baseline to follow-up at 1,3 and 6 months. Penile curvature is measured on pictures submitted by the patient.
3 secondary outcomes
Change in pain score using the Visual Analogue Scale (VAS)
Time frame: VAS will be assessed at baseline, and 1,3 and 6 months.
Change in Erectile function using the International Index of Erectile Function 5 (IIEF-5).
Time frame: IIEF-5 will be assessed at baseline, and 1,3 and 6 months.
Change in Peyronies disease questionnaire score
Time frame: Peyronies disease questionnaire will be assessed at baseline, and 1,3 and 6 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-intensity extracorporeal shockwave therapy and Penile pump in people with Peyronie Disease, 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 6 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: status not confirmed, as of the sponsor's last update on 14 Mar 2019. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in penile curvature (time frame: penile curve will be assessed at baseline, and 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 14 Mar 2019.