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

NCT ID: NCT05366517

Last Updated: 2022-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2023-12-31

Brief 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

Conditions

Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group

LiST active treatment group

Group Type: OTHER

Dornier Aries 2 device

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Institute for the Study of Urological Diseases, Greece

OTHER

Sponsor Role: lead

Responsible Party

Dimitrios Hatzichristou

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dimitrios Hatzichristou, Professor

Role: PRINCIPAL_INVESTIGATOR

Institute for the Study of Urological Diseases, Thessaloniki, Greece

Central Contacts

Paraskevi kapoteli

Role: CONTACT

pkapotel@auth.gr

2310963102 ext. +30

Other Identifiers

IMOP CPPS

Identifier Type: -

Identifier Source: org_study_id