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Completed

NCT Number: NCT03543761

Low-intensity Shockwave Therapy for Non-bacterial Prostatitis/Pelvic Pain Syndrome

The aim of the study is to investigate and compare the treatment efficacy and safety of ESWT vs sham treatment for CP/CPPS patients.This is a triple-blind, randomized, parallel group sham-controlled clinical study.

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Key information

Conditions

Chronic Prostatitis

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

G.Gennimatas Hospital

Thessaloniki, 54621, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant must 18 to 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

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.
  • PI-RADS score 4-5 in the baseline prostate mpMRI
  • PI-RADS score 3, PSA>3 and age > 40 years
  • Positive (suspicious for malignancy) DRE.

Treatment and study plan

Dornier Aries 2 device

Device
  • Sham group: 6 sessions with placebo LiST probe, 1 session per week. A specific probe design, identical to the active one will allow the double blind fashion of the study.

Primary outcomes

  1. The difference between the LiST and sham group in the change of the pain domain of NIH-CPSI score

    Time frame: 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.

Secondary outcomes

  1. The difference between the LiST and sham group in the change of total NIH-CPSI score (Q1-9)

    Time frame: baseline, 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).

  2. The difference between the LiST and sham group in the change of urinary symptoms (Q 5-6) and quality of life domains (Q 7-9) of the NIH-CPSI score

    Time frame: 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.

  3. The difference between the LiST and sham group in the change of quality of life domains (Q 7-9) of the NIH-CPSI score

    Time frame: 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 quality of life domain (items 7-9) and the score for this domain ranges from 0 to 12.

  4. The difference between the LiST and sham group in the change of IIEF-ED score

    Time frame: from baseline to 4 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

  5. The difference between the LiST and sham group in the change of IPSS

    Time frame: from baseline to 4 weeks after final treatment.

    They will be assessed by the International Prostate Symptom Score (IPSS). A questionnaire designed to provide information on lower urinary tract symptoms and their impact on quality of life. Scores range from 0 to 35. The severity categories are: 1-7 mild, 8-19 moderate, 20-35 severe

  6. The difference between the LiST and sham group in the change of Maximum urinary flow rate (Qmax)/ Post Void Residual (PVR)

    Time frame: from baseline to 4 weeks after final treatment.

    Qmax will be measured by uroflowmetry/ PVR will be measured by ultrasound

  7. The difference between the LiST and sham group in the change of UPPOINTS phenotype- number of positive domains

    Time frame: from baseline to 4 weeks after final treatment.

  8. The difference between the LiST and sham group in the the Pain Visual Analogue Scale (VAS)

    Time frame: at week 3, 4, 5, 6, 7 and 8

    It will be assessed by the pain VAS, right after each LIST session. Pain VAS is a unidimensional measure of pain intensity . It is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]. To avoid clustering of scores around a preferred numeric value, numbers or verbal descriptors at intermediate points are not recommended. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm)

  9. Changes in mpMRI of the prostate

    Time frame: baseline and 12 weeks after treatment

  10. Adverse events rate in all patients

    Time frame: 18 weeks

    Potential treatment related adverse events after the first LIST session and during the 3 month follow up period will be reported

Sponsors and collaborators

Lead sponsor

Institute for the Study of Urological Diseases, Greece

Other

Registry information

Official study title

Evaluation of Low-intensity Shockwave Therapy for Non-bacterial Prostatitis/Pelvic Pain Syndrome: a Triple-blind Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 1, 2018
Registry last updated
Mar 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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