Back to resultsThe Ideal LiST Session Frequency Protocol for CPPS Treatment
Primary Purpose
Chronic Pelvic Pain Syndrome, Chronic Non-bacterial Prostatitis Type IIIB
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Low intensity shockwave therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pelvic Pain Syndrome
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.
- PSA>3 and age > 40 years
- Positive (suspicious for malignancy) digital rectal examination (DRE).
Sites / Locations
- G.Gennimatas Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
Group B
Arm Description
Patients will receive 6 Low-intensity shockwave therapy (LiST) sessions (1/week) by using Dornier Aries 2 shockwave machine (energy level 7)
Patients will receive 6 Low-intensity shockwave therapy (LiST) sessions (2/week) by using Dornier Aries 2 shockwave machine (energy level 7)
Outcomes
Primary Outcome Measures
1.The difference between groups 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 groups 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 groups 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 groups 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 groups 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 groups 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)
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
NCT ID
NCT04549389
First Posted
September 8, 2020
Last Updated
February 11, 2021
Sponsor
Institute for the Study of Urological Diseases, Greece
1. Study Identification
Unique Protocol Identification Number
NCT04549389
Brief Title
The Ideal LiST Session Frequency Protocol for CPPS Treatment
Official Title
Comparing 2 Frequency Protocols of Low-intensity Shockwave Therapy for Non-bacterial Chronic Prostatitis Type IIIb /Chronic Pelvic Pain Syndrome: a Randomised Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
October 16, 2020 (Actual)
Study Completion Date
January 15, 2021 (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 study will include 50 chronic pelvic pain syndrome (CPPS) patients who will be randomised in 2 groups.
Group A (25 patients )will receive 6 LiST sessions with a frequency 1 session / week.
Group B (25 patients) will receive 6 LiST sessions with a frequency 2 sessions / week.
National Institutes of Health Chronic Prostatitis Symptom Index(NHI-CPSI), International Prostate Symptom Score (IPSS), International Index of Erectile Function (IIEF-ED) questionnaires will be answered before and at 1 and 3 month follow up visit.
Adverse events will be reported during the treatment and follow up period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pelvic Pain Syndrome, Chronic Non-bacterial Prostatitis Type IIIB
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Patients will receive 6 Low-intensity shockwave therapy (LiST) sessions (1/week) by using Dornier Aries 2 shockwave machine (energy level 7)
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
Patients will receive 6 Low-intensity shockwave therapy (LiST) sessions (2/week) by using Dornier Aries 2 shockwave machine (energy level 7)
Intervention Type
Device
Intervention Name(s)
Low intensity shockwave therapy
Intervention Description
LiST will be applied in the perineum of the patients by using Dornier Aries 2 shockwave machine (5000shockwaves per session, energy level 7)
Primary Outcome Measure Information:
Title
1.The difference between groups 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 groups 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
Time Frame: baseline, 4 and 12 weeks after final treatment
Title
The difference between groups 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 groups 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 and 12 weeks after final treatment
Title
The difference between groups 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 and 12 weeks after final treatment
Title
The difference between groups 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,
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.
PSA>3 and age > 40 years
Positive (suspicious for malignancy) digital rectal examination (DRE).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitrios Hatzichristou, Professor
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
Learn more about this trial
The Ideal LiST Session Frequency Protocol for CPPS Treatment
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