Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Ideal LiST Session Frequency Protocol for CPPS Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04549389
Recruitment Status : Completed
First Posted : September 16, 2020
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Dimitrios Hatzichristou, Institute for the Study of Urological Diseases, Greece

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Chronic Pelvic Pain Syndrome Chronic Non-bacterial Prostatitis Type IIIB Device: Low intensity shockwave therapy Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: 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
Actual Study Start Date : March 2, 2020
Actual Primary Completion Date : October 16, 2020
Actual Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Group A
Patients will receive 6 Low-intensity shockwave therapy (LiST) sessions (1/week) by using Dornier Aries 2 shockwave machine (energy level 7)
 Device: Low intensity shockwave therapy
LiST will be applied in the perineum of the patients by using Dornier Aries 2 shockwave machine (5000shockwaves per session, energy level 7)
Active Comparator: Group B
Patients will receive 6 Low-intensity shockwave therapy (LiST) sessions (2/week) by using Dornier Aries 2 shockwave machine (energy level 7)
 Device: Low intensity shockwave therapy
LiST will be applied in the perineum of the patients by using Dornier Aries 2 shockwave machine (5000shockwaves per session, energy level 7)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 1.The difference between groups 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.


Secondary Outcome Measures :
  1. The difference between groups in the change of total NIH-CPSI score (Q1-9) [ Time Frame: 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)

  2. 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 [ 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

  3. The difference between groups in the change of IIEF-ED score [ Time Frame: from baseline to 4 and 12 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

  4. The difference between groups in the change of IPSS [ Time Frame: from baseline to 4 and 12 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

  5. The difference between groups in the the Pain Visual Analogue Scale (VAS) [ Time Frame: at week 3, 4, 5, ]
    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)

  6. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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. PSA>3 and age > 40 years
  11. Positive (suspicious for malignancy) digital rectal examination (DRE).
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04549389


Locations
Layout table for location information
Greece
G.Gennimatas Hospital
Thessaloniki, Greece, 54621
Sponsors and Collaborators
Institute for the Study of Urological Diseases, Greece
Investigators
Layout table for investigator information
Principal Investigator: Dimitrios Hatzichristou, Professor Institute for the Study of Urological Diseases, Thessaloniki, Greece
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dimitrios Hatzichristou, President, Institute for the Study of Urological Diseases Theesaloniki, Greece, Institute for the Study of Urological Diseases, Greece
ClinicalTrials.gov Identifier: NCT04549389    
Other Study ID Numbers: 1410/2020
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatitis
Syndrome
Pelvic Pain
Disease
 Pathologic Processes
Pain
Neurologic Manifestations
Prostatic Diseases