Chronic ProstatitisNCT03543761

Low-intensity Shockwave Therapy for Non-bacterial Prostatitis/Pelvic Pain Syndrome

A study testing Dornier Aries 2 device in people with Chronic Prostatitis, run by Institute for the Study of Urological Diseases, Greece at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The aim of the study is to investigate and compare the treatment efficacy and safety of ESWT vs sham treatment for CP/CPPS patients.This is a triple-blind, randomized, parallel group sham-controlled clinical study. Read more about this study

Who is it for?: Ages 18 to 60 years, men only
Conditions the study is for: Chronic Prostatitis
What is being tested?: Dornier Aries 2 device
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: 1 siteGreece
Study dates: 11 Jun 2018to 20 Dec 2019
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 60 years
Men only
No healthy volunteers
Adult

Who may be able to join

Participant must 18 to 60 years of age.
Participant has signed and dated the appropriate Informed Consent document.
Participant has had a clinical diagnosis of CP/CPPS defined as symptoms of discomfort or pain in the perineal or pelvic region for at least a three (3) month period within the last six (6) months

Who cannot join

Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU/ml in mid-stream urine (VB2).
Participant has a history of prostate, bladder or urethral cancer.
Participant has undergone pelvic radiation or systemic chemotherapy.
Participant has undergone intravesical chemotherapy.
Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture or bladder stones, or any other urological condition associated with LUTS, any neurological disease or disorder affecting the bladder.
Participant has undergone prostate surgery or treatment.

Show all 12Show fewer

Participant with penile or urinary sphincter implants.
Participant has been diagnosed with cancer during the last 5 years, or had any surgery in the pelvis.
Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
PI-RADS score 4-5 in the baseline prostate mpMRI
PI-RADS score 3, PSA>3 and age > 40 years
Positive (suspicious for malignancy) DRE.

Trial locations and contacts

1 site in 1 country.

Greece1 site

G.Gennimatas Hospital
Thessaloniki, 54621

Other trials in Greece

About this study

Official title: Evaluation of Low-intensity Shockwave Therapy for Non-bacterial Prostatitis/Pelvic Pain Syndrome: a Triple-blind Randomized Controlled Trial

Conditions: Chronic Prostatitis
Being tested: Dornier Aries 2 device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dornier Aries 2 deviceDevice
- Sham group: 6 sessions with placebo LiST probe, 1 session per week. A specific probe design, identical to the active one will allow the double blind fashion of the study.
Dornier Aries 2 deviceDevice
LiST groups: 6 sessions with active LiS probe, 1 session per week. The ARIES 2 device by Dornier will be used with a treatment protocol: 5000 SW, energy flux density = 0.096 mJ/mm2 (energy level 7)
Dornier Aries 2 deviceDevice
LiST groups: 6 sessions with active LiS probe, 1 session per week. The ARIES 2 device by Dornier will be used with a treatment protocol: 5000 SW, energy flux density = 0.096 mJ/mm2 (energy level 7)

Study groups in NCT03543761
Study group	Role	What they receive
A	Sham comparator	Sham group Receives: Device: Dornier Aries 2 device
B	Active comparator	LiST active treatment group Receives: Device: Dornier Aries 2 device
C	Active comparator	LiST active treatment group Receives: Device: Dornier Aries 2 device

What is being measured

The primary outcome is the main question the study is designed to answer.

The difference between the LiST and sham group in the change of the pain domain of NIH-CPSI score
CP/CPPS-related complaints will be assessed by the the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). The questionnaire designed to provide symptom scores for patients with chronic prostatitis. The index provides scores on pain (items 1-4), urinary symptoms (items 5-6), and quality of life (items 7-9).Total score ranges from 0 to 35 (higher values represent worse outcome).The index provides a special pain domain (items 1-4) and the score for this domain ranges from 0 to 21.
Measured: from baseline to 12 weeks after final treatment.

Secondary outcomes (10)

The difference between the LiST and sham group in the change of total NIH-CPSI score (Q1-9)
CP/CPPS-related complaints will be assessed by the the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). The questionnaire designed to provide symptom scores for patients with chronic prostatitis. The index provides scores on pain (items 1-4), urinary symptoms (items 5-6), and quality of life (items 7-9).Total score ranges from 0 to 35 (higher values represent worse outcome).
Measured: baseline, 4 and 12 weeks after final treatment
The difference between the LiST and sham group in the change of urinary symptoms (Q 5-6) and quality of life domains (Q 7-9) of the NIH-CPSI score
CP/CPPS-related complaints will be assessed by the the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). The questionnaire designed to provide symptom scores for patients with chronic prostatitis. The index provides scores on pain (items 1-4), urinary symptoms (items 5-6), and quality of life (items 7-9).Total score ranges from 0 to 35 (higher values represent worse outcome).The index provides a special urinary symptom domain (items 5-6) and the score for this domain ranges from 0 to 10.
Measured: from baseline to 4 and 12 weeks after final treatment
The difference between the LiST and sham group in the change of quality of life domains (Q 7-9) of the NIH-CPSI score
CP/CPPS-related complaints will be assessed by the the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). The questionnaire designed to provide symptom scores for patients with chronic prostatitis. The index provides scores on pain (items 1-4), urinary symptoms (items 5-6), and quality of life (items 7-9).Total score ranges from 0 to 35 (higher values represent worse outcome).The index provides a special quality of life domain (items 7-9) and the score for this domain ranges from 0 to 12.
Measured: from baseline to 4 and 12 weeks after final treatment
The difference between the LiST and sham group in the change of IIEF-ED score
It will be assessed by International Index of Erectile Function -Erectile Domain (IEF-ED) score. A questionnaire designed to evaluate erectile capabilities. The questionnaire provides a score between 5 and 30.The severity categories are: 1-10 severe ED, 10-16 moderate ED, 17-21 moderate to mild ED, 22-25 mild ED, 26-30 no ED
Measured: from baseline to 4 weeks after final treatment.
The difference between the LiST and sham group in the change of IPSS
They will be assessed by the International Prostate Symptom Score (IPSS). A questionnaire designed to provide information on lower urinary tract symptoms and their impact on quality of life. Scores range from 0 to 35. The severity categories are: 1-7 mild, 8-19 moderate, 20-35 severe
Measured: from baseline to 4 weeks after final treatment.
The difference between the LiST and sham group in the change of Maximum urinary flow rate (Qmax)/ Post Void Residual (PVR)
Qmax will be measured by uroflowmetry/ PVR will be measured by ultrasound
Measured: from baseline to 4 weeks after final treatment.
The difference between the LiST and sham group in the change of UPPOINTS phenotype- number of positive domains
Measured: from baseline to 4 weeks after final treatment.
The difference between the LiST and sham group in the the Pain Visual Analogue Scale (VAS)
It will be assessed by the pain VAS, right after each LIST session. Pain VAS is a unidimensional measure of pain intensity . It is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]. To avoid clustering of scores around a preferred numeric value, numbers or verbal descriptors at intermediate points are not recommended. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm)
Measured: at week 3, 4, 5, 6, 7 and 8
Changes in mpMRI of the prostate
Measured: baseline and 12 weeks after treatment
Adverse events rate in all patients
Potential treatment related adverse events after the first LIST session and during the 3 month follow up period will be reported
Measured: 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jun 201820 Dec 2019

First posted1 Jun 2018
Study start11 Jun 2018
Primary completion2 Sep 2019
Study completion20 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Chronic ProstatitisStudies of the same condition, open and under way.
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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03543761
Sponsor's protocol ID: 1340/2018
Status last verified: Feb 2020
First submitted: 25 Apr 2018
Last updated: 2 Mar 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Zimmermann R, Cumpanas A, Miclea F, Janetschek G. Extracorporeal shock wave therapy for the treatment of chronic pelvic pain syndrome in males: a randomised, double-blind, placebo-controlled study. Eur Urol. 2009 Sep;56(3):418-24. doi: 10.1016/j.eururo.2009.03.043. Epub 2009 Mar 25.
PubMed 19372000
Al Edwan GM, Muheilan MM, Atta ON. Long term efficacy of extracorporeal shock wave therapy [ESWT] for treatment of refractory chronic abacterial prostatitis. Ann Med Surg (Lond). 2017 Jan 6;14:12-17. doi: 10.1016/j.amsu.2016.12.051. eCollection 2017 Feb.
PubMed 28119778

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Enrolling by invitation
Pulsed Electromagnetic Versus Hydrotherapy on Chronic Pelvic Pain
Chronic Pelvic Pain Syndrome
Recruiting
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction
RecruitingObservational study
Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Prostatitis (CP), Chronic Pelvic Pain Syndrome (CPPS)
Recruiting
Oxiblume:CoQ10 (Ralivia) Therapy for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Pelvic Pain Syndrome (CPPS)

All Chronic Prostatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Low-intensity Shockwave Therapy for Non-bacterial Prostatitis/Pelvic Pain Syndrome: a Triple-blind Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03543761
Acronym / sponsor ID: 1340/2018
Conditions: Chronic Prostatitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Institute for the Study of Urological Diseases, GreeceUniversity, hospital or other
Study start: 11 Jun 2018 (actual)
Primary completion: 2 Sep 2019 (actual)
Study completion: 20 Dec 2019 (actual)
First posted: 1 Jun 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
A	Sham comparator	Device: Dornier Aries 2 deviceSham group
B	Active comparator	Device: Dornier Aries 2 deviceLiST active treatment group
C	Active comparator	Device: Dornier Aries 2 deviceLiST active treatment group

Who may qualify

Ages: 18 to 60 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Participant must 18 to 60 years of age.
Participant has signed and dated the appropriate Informed Consent document.
Participant has had a clinical diagnosis of CP/CPPS defined as symptoms of discomfort or pain in the perineal or pelvic region for at least a three (3) month period within the last six (6) months

Key exclusion criteria (12 listed)

Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU/ml in mid-stream urine (VB2).
Participant has a history of prostate, bladder or urethral cancer.
Participant has undergone pelvic radiation or systemic chemotherapy.
Participant has undergone intravesical chemotherapy.
Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture or bladder stones, or any other urological condition associated with LUTS, any neurological disease or disorder affecting the bladder.

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
Dornier Aries 2 device• Sham group: 6 sessions with placebo LiST probe, 1 session per week. A specific probe design, identical to the active one will allow the double blind fashion of the study.	Device	A
Dornier Aries 2 deviceLiST groups: 6 sessions with active LiS probe, 1 session per week. The ARIES 2 device by Dornier will be used with a treatment protocol: 5000 SW, energy flux density = 0.096 mJ/mm2 (energy level 7)	Device	B
Dornier Aries 2 deviceLiST groups: 6 sessions with active LiS probe, 1 session per week. The ARIES 2 device by Dornier will be used with a treatment protocol: 5000 SW, energy flux density = 0.096 mJ/mm2 (energy level 7)	Device	C

Primary outcome

The difference between the LiST and sham group in the change of the pain domain of NIH-CPSI score
Time frame: from baseline to 12 weeks after final treatment.
CP/CPPS-related complaints will be assessed by the the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). The questionnaire designed to provide symptom scores for patients with chronic prostatitis. The index provides scores on pain (items 1-4), urinary symptoms (items 5-6), and quality of life (items 7-9).Total score ranges from 0 to 35 (higher values represent worse outcome).The index provides a special pain domain (items 1-4) and the score for this domain ranges from 0 to 21.

10 secondary outcomes

The difference between the LiST and sham group in the change of total NIH-CPSI score (Q1-9)
Time frame: baseline, 4 and 12 weeks after final treatment
The difference between the LiST and sham group in the change of urinary symptoms (Q 5-6) and quality of life domains (Q 7-9) of the NIH-CPSI score
Time frame: from baseline to 4 and 12 weeks after final treatment
The difference between the LiST and sham group in the change of quality of life domains (Q 7-9) of the NIH-CPSI score
Time frame: from baseline to 4 and 12 weeks after final treatment
The difference between the LiST and sham group in the change of IIEF-ED score
Time frame: from baseline to 4 weeks after final treatment.
The difference between the LiST and sham group in the change of IPSS
Time frame: from baseline to 4 weeks after final treatment.
The difference between the LiST and sham group in the change of Maximum urinary flow rate (Qmax)/ Post Void Residual (PVR)
Time frame: from baseline to 4 weeks after final treatment.
The difference between the LiST and sham group in the change of UPPOINTS phenotype- number of positive domains
Time frame: from baseline to 4 weeks after final treatment.
The difference between the LiST and sham group in the the Pain Visual Analogue Scale (VAS)
Time frame: at week 3, 4, 5, 6, 7 and 8
Changes in mpMRI of the prostate
Time frame: baseline and 12 weeks after treatment
Adverse events rate in all patients
Time frame: 18 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
Background: PubMed 19372000Zimmermann R, Cumpanas A, Miclea F, Janetschek G. Extracorporeal shock wave therapy for the treatment of chronic pelvic pain syndrome in males: a randomised, double-blind, placebo-controlled study. Eur Urol. 2009 Sep;56(3):418-24. doi: 10.1016/j.eururo.2009.03.043. Epub 2009 Mar 25.
Background: PubMed 28119778Al Edwan GM, Muheilan MM, Atta ON. Long term efficacy of extracorporeal shock wave therapy [ESWT] for treatment of refractory chronic abacterial prostatitis. Ann Med Surg (Lond). 2017 Jan 6;14:12-17. doi: 10.1016/j.amsu.2016.12.051. eCollection 2017 Feb.
Individual participant dataSharing planned: No

Related trials for Chronic Prostatitis

Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Enrolling by invitation
Pulsed Electromagnetic Versus Hydrotherapy on Chronic Pelvic Pain
Chronic Pelvic Pain Syndrome
Recruiting
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction
RecruitingObservational study
Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Prostatitis (CP), Chronic Pelvic Pain Syndrome (CPPS)
Recruiting
Oxiblume:CoQ10 (Ralivia) Therapy for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Pelvic Pain Syndrome (CPPS)

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.

Dimitrios Hatzichristou, Prof. principal investigator

Institute for the Study of Urological Diseases, Thessaloniki, Greece

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dornier Aries 2 device in people with Chronic Prostatitis, run by Institute for the Study of Urological Diseases, Greece at 1 site in Greece.

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 12 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: finished, as of the sponsor's last update on 2 Mar 2020. 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 Greece. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The difference between the LiST and sham group in the change of the pain domain of NIH-CPSI score (time frame: from baseline to 12 weeks after final treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03543761, which also lists 2 linked publications.

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 2 Mar 2020.