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

NCT05366517 | Unknown

• 1 other identifier: IMOP CPPS
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The change of the pain domain of NIH-CPSI score from baseline to 4 weeks after final treatment.

  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

  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

  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

  baseline, 4 and 12 weeks after final treatment

• The change of IIEF-ED score from baseline to 4 and 12 weeks after final treatment

  baseline, 4 and 12 weeks after final treatment

Study Arms (1)

Group

OTHER

LiST active treatment group

Device: Dornier Aries 2 device

Interventions

Dornier Aries 2 device 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

Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participant must be between 18-60 years of age.
• Participant has signed and dated the appropriate Informed Consent document.
• 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.
• 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).

You may not qualify if:

• Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU/ml in mid-stream urine (VB2).
• Participant has a history of prostate, bladder or urethral cancer.
• Participant has undergone pelvic radiation or systemic chemotherapy.
• Participant has undergone intravesical chemotherapy.
• 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.
• Participant has undergone prostate surgery or treatment.
• Participant with penile or urinary sphincter implants.
• Participant has been diagnosed with cancer during the last 5 years, or had any surgery in the pelvis.
• Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.

Sponsors & Collaborators

• Institute for the Study of Urological Diseases, Greece: lead

MeSH Terms

Conditions

Prostatitis

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Dimitrios Hatzichristou, Professor

  Institute for the Study of Urological Diseases, Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paraskevi kapoteli

CONTACT

2310963102; pkapotel@auth.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share