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

NCT03543761 | Completed

• 1 other identifier: 1340/2018
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Prostatitis

Outcome Measures

Primary Outcomes (1)

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

  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 (10)

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

  baseline, 4 and 12 weeks after final treatment

• 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

  from baseline to 4 and 12 weeks after final treatment

• The difference between the LiST and sham group in 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

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

  from baseline to 4 weeks after final treatment.

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

  from baseline to 4 weeks after final treatment.

Study Arms (3)

A

SHAM COMPARATOR

Sham group

Device: Dornier Aries 2 device

B

ACTIVE COMPARATOR

LiST active treatment group

Device: Dornier Aries 2 device

C

ACTIVE COMPARATOR

LiST active treatment group

Device: Dornier Aries 2 device

Interventions

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.

A

Eligibility Criteria

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

You may qualify if:

• 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

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.
• 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.

Sponsors & Collaborators

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

Study Sites (1)

G.Gennimatas Hospital

Thessaloniki, 54621, Greece

Location

Related Publications (2)

• Zimmermann R, Cumpanas A, Miclea F, Janetschek G. Extracorporeal shock wave therapy for the treatment of chronic pelvic pain syndrome in males: a randomised, double-blind, placebo-controlled study. Eur Urol. 2009 Sep;56(3):418-24. doi: 10.1016/j.eururo.2009.03.043. Epub 2009 Mar 25.

  PMID: 19372000 BACKGROUND

• Al Edwan GM, Muheilan MM, Atta ON. Long term efficacy of extracorporeal shock wave therapy [ESWT] for treatment of refractory chronic abacterial prostatitis. Ann Med Surg (Lond). 2017 Jan 6;14:12-17. doi: 10.1016/j.amsu.2016.12.051. eCollection 2017 Feb.

  PMID: 28119778 BACKGROUND

Study Officials

• Dimitrios Hatzichristou, Prof.

  Institute for the Study of Urological Diseases, Thessaloniki, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President, Institute for the Study of Urological Diseases Theesaloniki, Greece

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: June 1, 2018
• Study Start: June 11, 2018
• Primary Completion: September 2, 2019
• Study Completion: December 20, 2019
• Last Updated: March 2, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)