The Ideal LiST Session Frequency Protocol for CPPS Treatment

Comparing 2 Frequency Protocols of Low-intensity Shockwave Therapy for Non-bacterial Chronic Prostatitis Type IIIb /Chronic Pelvic Pain Syndrome: a Randomised Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pelvic Pain Syndrome; Chronic Non-bacterial Prostatitis Type IIIB
• Intervention / Treatment: Device: Low intensity shockwave therapy

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Thessaloniki, Greece, 54621
    • G.Gennimatas Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from baseline to 12 weeks after final treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Time Frame: baseline, 4 and 12 weeks after final treatment
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	from baseline to 4 and 12 weeks after final treatment
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	from baseline to 4 and 12 weeks after final treatment
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	from baseline to 4 and 12 weeks after final treatment
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)	at week 3, 4, 5,
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	18 weeks

Collaborators and Investigators

• Sponsor: Institute for the Study of Urological Diseases, Greece
• Investigators: Principal Investigator: Dimitrios Hatzichristou, Professor, Institute for the Study of Urological Diseases, Thessaloniki, Greece

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2020
• Primary Completion (Actual): October 16, 2020
• Study Completion (Actual): January 15, 2021

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 8, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease; Prostatic Diseases; Syndrome; Pelvic Pain; Prostatitis
• Other Study ID Numbers: 1410/2020

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