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

Chronic Prostatitis With Chronic Pelvic Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05366517
• Other study ID #: IMOP CPPS
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: Institute for the Study of Urological Diseases, Greece
• Contact: Paraskevi kapoteli
• Phone: 2310963102
• Email: pkapotel[@]auth.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Prostatitis With Chronic Pelvic Pain Syndrome
• Pelvic Pain
• Prostatitis
• Somatoform Disorders
• Syndrome

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institute for the Study of Urological Diseases, Greece

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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