- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03543761
Low-intensity Shockwave Therapy for Non-bacterial Prostatitis/Pelvic Pain Syndrome
February 28, 2020 updated by: Dimitrios Hatzichristou, Institute for the Study of Urological Diseases, Greece
Evaluation of Low-intensity Shockwave Therapy for Non-bacterial Prostatitis/Pelvic Pain Syndrome: a Triple-blind Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Thessaloniki, Greece, 54621
- G.Gennimatas Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: A
Sham group
|
• 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.
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)
|
Active Comparator: B
LiST active treatment group
|
• 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.
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)
|
Active Comparator: C
LiST active treatment group
|
• 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.
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
from baseline to 12 weeks after final treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events rate in all patients
Time Frame: 18 weeks
|
Potential treatment related adverse events after the first LIST session and during the 3 month follow up period will be reported
|
18 weeks
|
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
|
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).
|
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
|
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.
|
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
|
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.
|
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.
|
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
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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.
|
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
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from baseline to 4 weeks after final treatment.
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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.
|
Qmax will be measured by uroflowmetry/ PVR will be measured by ultrasound
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from baseline to 4 weeks after final treatment.
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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.
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from baseline to 4 weeks after final treatment.
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|
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
|
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)
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at week 3, 4, 5, 6, 7 and 8
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Changes in mpMRI of the prostate
Time Frame: baseline and 12 weeks after treatment
|
baseline and 12 weeks after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. Erratum In: Eur Urol. 2020 May;77(5):e140.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 11, 2018
Primary Completion (Actual)
September 2, 2019
Study Completion (Actual)
December 20, 2019
Study Registration Dates
First Submitted
April 25, 2018
First Submitted That Met QC Criteria
May 20, 2018
First Posted (Actual)
June 1, 2018
Study Record Updates
Last Update Posted (Actual)
March 2, 2020
Last Update Submitted That Met QC Criteria
February 28, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1340/2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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