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

Primary Purpose

Chronic Prostatitis

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Dornier Aries 2 device
Dornier Aries 2 device
Dornier Aries 2 device
Sponsored by
Institute for the Study of Urological Diseases, Greece
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Prostatitis

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Participant must 18 to 60 years of age.
  2. Participant has signed and dated the appropriate Informed Consent document.
  3. 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:

  1. Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU/ml in mid-stream urine (VB2).
  2. Participant has a history of prostate, bladder or urethral cancer.
  3. Participant has undergone pelvic radiation or systemic chemotherapy.
  4. Participant has undergone intravesical chemotherapy.
  5. 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.
  6. Participant has undergone prostate surgery or treatment.
  7. Participant with penile or urinary sphincter implants.
  8. Participant has been diagnosed with cancer during the last 5 years, or had any surgery in the pelvis.
  9. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.
  10. PI-RADS score 4-5 in the baseline prostate mpMRI
  11. PI-RADS score 3, PSA>3 and age > 40 years
  12. Positive (suspicious for malignancy) DRE.

Sites / Locations

  • G.Gennimatas Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Sham Comparator

Active Comparator

Active Comparator

Arm Label

A

B

C

Arm Description

Sham group

LiST active treatment group

LiST active treatment group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.
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
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
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
The difference between the LiST and sham group in the change of UPPOINTS phenotype- number of positive domains
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)
Changes in mpMRI of the prostate
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

Full Information

First Posted
April 25, 2018
Last Updated
February 28, 2020
Sponsor
Institute for the Study of Urological Diseases, Greece
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1. Study Identification

Unique Protocol Identification Number
NCT03543761
Brief Title
Low-intensity Shockwave Therapy for Non-bacterial Prostatitis/Pelvic Pain Syndrome
Official Title
Evaluation of Low-intensity Shockwave Therapy for Non-bacterial Prostatitis/Pelvic Pain Syndrome: a Triple-blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 11, 2018 (Actual)
Primary Completion Date
September 2, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute for the Study of Urological Diseases, Greece

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Prostatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Sham Comparator
Arm Description
Sham group
Arm Title
B
Arm Type
Active Comparator
Arm Description
LiST active treatment group
Arm Title
C
Arm Type
Active Comparator
Arm Description
LiST active treatment group
Intervention Type
Device
Intervention Name(s)
Dornier Aries 2 device
Intervention Description
• 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.
Intervention Type
Device
Intervention Name(s)
Dornier Aries 2 device
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
Dornier Aries 2 device
Intervention Description
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)
Primary Outcome Measure Information:
Title
The difference between the LiST and sham group in the change of the pain domain of NIH-CPSI score
Description
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.
Time Frame
from baseline to 12 weeks after final treatment.
Secondary Outcome Measure Information:
Title
The difference between the LiST and sham group in the change of total NIH-CPSI score (Q1-9)
Description
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).
Time Frame
baseline, 4 and 12 weeks after final treatment
Title
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
Description
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.
Time Frame
from baseline to 4 and 12 weeks after final treatment
Title
The difference between the LiST and sham group in the change of quality of life domains (Q 7-9) of the NIH-CPSI score
Description
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.
Time Frame
from baseline to 4 and 12 weeks after final treatment
Title
The difference between the LiST and sham group in the change of IIEF-ED score
Description
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
Time Frame
from baseline to 4 weeks after final treatment.
Title
The difference between the LiST and sham group in the change of IPSS
Description
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
Time Frame
from baseline to 4 weeks after final treatment.
Title
The difference between the LiST and sham group in the change of Maximum urinary flow rate (Qmax)/ Post Void Residual (PVR)
Description
Qmax will be measured by uroflowmetry/ PVR will be measured by ultrasound
Time Frame
from baseline to 4 weeks after final treatment.
Title
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.
Title
The difference between the LiST and sham group in the the Pain Visual Analogue Scale (VAS)
Description
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)
Time Frame
at week 3, 4, 5, 6, 7 and 8
Title
Changes in mpMRI of the prostate
Time Frame
baseline and 12 weeks after treatment
Title
Adverse events rate in all patients
Description
Potential treatment related adverse events after the first LIST session and during the 3 month follow up period will be reported
Time Frame
18 weeks

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitrios Hatzichristou, Prof.
Organizational Affiliation
Institute for the Study of Urological Diseases, Thessaloniki, Greece
Official's Role
Principal Investigator
Facility Information:
Facility Name
G.Gennimatas Hospital
City
Thessaloniki
ZIP/Postal Code
54621
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19372000
Citation
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.
Results Reference
background
PubMed Identifier
28119778
Citation
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.
Results Reference
background

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

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