Clinical trial NCT03543761: Low-intensity Shockwave Therapy for Non-bacterial Prostatitis/Pelvic Pain Syndrome
Official title: Evaluation of Low-intensity Shockwave Therapy for Non-bacterial Prostatitis/Pelvic Pain Syndrome: a Triple-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Prostatitis
Lead sponsor: Institute for the Study of Urological Diseases, Greece
Sponsor class: OTHER
First posted: 2018-06-01
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Participant must 18 to 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

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

Primary outcomes:
measure: The difference between the LiST and sham group in the change of the pain domain of NIH-CPSI score
timeFrame: from baseline to 12 weeks after final treatment.
Secondary outcomes:
measure: The difference between the LiST and sham group in the change of total NIH-CPSI score (Q1-9)
timeFrame: baseline, 4 and 12 weeks after final treatment
measure: 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
timeFrame: from baseline to 4 and 12 weeks after final treatment
measure: The difference between the LiST and sham group in the change of quality of life domains (Q 7-9) of the NIH-CPSI score
timeFrame: from baseline to 4 and 12 weeks after final treatment
measure: The difference between the LiST and sham group in the change of IIEF-ED score
timeFrame: from baseline to 4 weeks after final treatment.
measure: The difference between the LiST and sham group in the change of IPSS
timeFrame: from baseline to 4 weeks after final treatment.
measure: The difference between the LiST and sham group in the change of Maximum urinary flow rate (Qmax)/ Post Void Residual (PVR)
timeFrame: from baseline to 4 weeks after final treatment.
measure: The difference between the LiST and sham group in the change of UPPOINTS phenotype- number of positive domains
timeFrame: from baseline to 4 weeks after final treatment.
measure: The difference between the LiST and sham group in the the Pain Visual Analogue Scale (VAS)
timeFrame: at week 3, 4, 5, 6, 7 and 8
measure: Changes in mpMRI of the prostate
timeFrame: baseline and 12 weeks after treatment
measure: Adverse events rate in all patients
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: G.Gennimatas Hospital
Study officials:
affiliation: Institute for the Study of Urological Diseases, Thessaloniki, Greece
name: Dimitrios Hatzichristou, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.