Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05366517
Other study ID # IMOP CPPS
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04552431 - Chronic Prostatitis Collaborative Research Network Clinical Trial- Ciprofloxacin and Tamsulosin Phase 2
Terminated NCT02385266 - Treating Urological Chronic Pelvic Pain Syndrome (UCPPS) Pain Phase 4
Completed NCT00672087 - Diagnostic Challenges in IC (and Male CPPS)
Completed NCT03213938 - Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome N/A
Recruiting NCT00775515 - Laparoscopic Prostatectomy for Chronic Prostatitis Phase 2
Completed NCT01676857 - Chemokine Mechanisms in Chronic Pelvic Pain
Recruiting NCT06299683 - Pain Type and Interstitial Cystitis/Bladder Pain Syndrome Treatment N/A
Completed NCT00826514 - An Efficacy And Safety Study Of Tanezumab For The Treatment Of Pain Associated With Chronic Abacterial Prostatitis Phase 2
Completed NCT06064448 - Clinical Observation of Ningmitai Capsule in Treating Chronic Pelvic Pain Syndrome With Erectile Dysfunction Phase 4
Completed NCT04446598 - Management of Prostatodynia in Younger Patients With Non-ablative Erbium:YAG Intraurethral Laser N/A
Completed NCT00701311 - An Open-Label Study of CC-10004 for Chronic Prostatitis/Chronic Pelvic Pain Syndrome Phase 2
Completed NCT04275297 - Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome N/A
Active, not recruiting NCT05075551 - Analyzing the Brain Alterations of Acupuncture on Patients With CP/CPPS Evaluated by fMRI N/A
Recruiting NCT06385977 - Risk Factors for Chronic Prostatitis Patients in Northwest China
Completed NCT06016595 - Chronic Prostatitis/Chronic Pelvic Pain Syndrome Patients
Active, not recruiting NCT01828996 - Shocking Therapy for Chronic Pelvic Pain Syndrome N/A
Recruiting NCT03629769 - Effects of Proxelan Somministration in Patients With Chronic Prostatitis Phase 3
Recruiting NCT06345014 - The Efficacy and Safety of OM-89 in Patients With Recurrent Chronic Prostatitis/Chronic Pelvic Pain Syndrome Phase 4
Recruiting NCT06115083 - Effects of Pelvic Floor Training in Male Chronic Pelvic Pain, Correlation Between Subjective and Objective Outcomes N/A
Completed NCT03167216 - Mast Cells in Male Pelvic Pain and and Lower Urinary Tract Dysfunction Early Phase 1