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NCT05366517 | Not yet recruiting | Chronic Prostatitis With Chronic Pelvic Pain Syndrome

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

Institute for the Study of Urological Diseases, Greece

Information provided by (Responsible Party):

Dimitrios Hatzichristou

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

Condition or disease

Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Intervention/treatment

Dornier Aries 2 device

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 50 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Evaluation of Repeating Low-intensity Shockwave Therapy (LiST) for Refractory Non-bacterial Prostatitis/Pelvic Pain Syndrome: a Single Arm Prospective Study
Actual Study Start Date : September 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2023
Arm Intervention/treatment

Other: Group

LiST active treatment group

Device: Dornier Aries 2 device
Ages Eligible for Study: 18 Years to 60 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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).
Exclusion Criteria
  • 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.
Repeating LiST for Refractory Non-bacterial Prostatitis/Pelvic Pain Syndrome

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

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