Repeating LiST for Refractory Non-bacterial Prostatitis/Pelvic Pain Syndrome

Evaluation of Repeating Low-intensity Shockwave Therapy (LiST) for Refractory Non-bacterial Prostatitis/Pelvic Pain Syndrome: a Single Arm Prospective Study

The aim of the study is to investigate the efficacy and safety of LiST retreatment for CP/CPPS patients.A total of 50 patients with CP/CPPS diagnosis who were previously treated with 6 sessions of LiST will participate in this study.The primary study parameter is the CP/CPPS-related pain complaints and it will be assessed by the NIH-CPSI

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Prostatitis With Chronic Pelvic Pain Syndrome
• Intervention / Treatment: Device: Dornier Aries 2 device

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

Contacts and Locations

• Study Contact: Name: Paraskevi kapoteli; Phone Number: +30 2310963102; Email: pkapotel@auth.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Participant must be between 18-60 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.
4. Participant has received 6 sessions (1/week or 2/week, energy level 7, Dornier ARIES 2) of LIST the last 12 months for the treatment of CP/CPPS reporting amelioration but without complete remission of CP/CPPS symptoms ( at over 1 UPOINT positive domain).

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group; LiST active treatment group	Device: Dornier Aries 2 device; For 6 weeks, patients will receive 6 sessions with active LiST probe, 2 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) frequency = 5Hz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of the pain domain of NIH-CPSI score 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
The change of the pain domain of NIH-CPSI score from baseline to 4 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 4 weeks after final treatment.
The change of total NIH-CPSI score (Q1-9)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).	baseline, 4 and 12 weeks after final treatment
The change of urinary symptoms (Q 5-6) and quality of life domains (Q 7-9) of the NIH-CPSI score 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.	baseline, 4 and 12 weeks after final treatment
The change of quality of life domains (Q 7-9) of the NIH-CPSI score 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.	baseline, 4 and 12 weeks after final treatment
The change of IIEF-ED score 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	baseline, 4 and 12 weeks after final treatment
The difference between the LiST and sham group in the change of UPPOINTS phenotype- number of positive domainsfrom baseline to 4 and 12 weeks after final		baseline, 4 and 12 weeks after final treatment

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 (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 4, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Pain; Neurologic Manifestations; Disease; Prostatic Diseases; Syndrome; Somatoform Disorders; Pelvic Pain; Prostatitis
• Other Study ID Numbers: IMOP CPPS

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