Treatment of Chronic Prostatitis/ Pelvic Pain Syndrome With Low-intensity Extracorporeal Shockwave Therapy

NCT04014036 | Unknown

• 1 other identifier: NTUH-57401-19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, randomized, single-blinded, cross-over trial to investigate the efficacy of low-intensity extracorporeal shockwave therapy in the treatment of chronic pelvic pain syndrome (CPPS). We will enroll 60 subjects with Chronic Prostatitis Symptom Index (CPSI) \> 15. 30 subjects receive ESWT (LM-IASO, Litemed Co., Taiwan) for 6 courses in 3 weeks (0.05mJ/mm2, 3000 pulses) and 30 subjects receive Sham therapy for 3 weeks (the machine turning on but the energy is zero). After 3 weeks, the two groups are cross over, for additional 6 courses. The primary outcome is the the 4th week change from baseline for CPSI score. Secondary outcomes are the 8th week change from baseline for CPSI score, IIEF, QoL; AEs. The between-group relationships of baseline and 4-week data were evaluated by using the Student's t-test or Mann-Whitney U-test where appropriate. Multiple linear regression was carried out to test the variables associated with treatment outcome. P-values \< 0.05 were considered statistically significant.

Conditions

Chronic Prostatitis/ Pelvic Pain Syndrome

Keywords

chronic prostatitis/ pelvic pain syndrome; low-intensity extracorporeal shockwave therapy

Outcome Measures

Primary Outcomes (1)

• CPSI score

  the 4th and the 8th week change from baseline for CPSI score. 1. In the last week, have you experienced any pain / discomfort? 1. perineum 2. Testicles 3. Tip of the penis 4. pubic area 2. In the last week, have you: 1. Pain or burning during urination? 2. discomfort after sexual climax? 3. How often have you had pain over the last week? 0 Never \~ 5 Always 4. Which number describes your AVERAGE pain / discomfort over the last week? 0 \~10 5. How often have you had a sensation of not emptying your bladder completely after you finished urinating? 0 Not at all \~ 5 Almost always 6. How often have you had to urinate again \<2 hours you finished urinating? 0 Not at all \~ 5 Almost always 7. Your symptoms kept you over the last week? 0 None \~ 3 A lot 8. How much did you think about your symptoms, over the last week? 0 None \~ 3 A lot 9. If your symptoms persists during the rest of your life, how would how would you feel? 0-6

  the 4th week and the 8th week

Secondary Outcomes (1)

• IIEF-5 score

  the 4th week and the 8th week

Study Arms (2)

1

EXPERIMENTAL

30 subjects receive ESWT (LM-IASO, Litemed Co., Taiwan) for 6 courses in 3 weeks (0.05mJ/mm2, 3000 pulses). Thereafter, the two groups are cross over.

Device: low energy extracorporeal shockwave therapy

2

SHAM COMPARATOR

30 subjects receive Sham therapy for 3 weeks (the machine turning on but the energy is zero). Thereafter, the two groups are cross over.

Device: low energy extracorporeal shockwave therapy

Interventions

low energy extracorporeal shockwave therapy DEVICE

Low-intensity extracorporeal shockwave therapy (LI-ESWT) was proved to be useful in various medical conditions; for example, neovascularization in myocardial ischemia, nonhealing wounds, ED and chronic pelvic pain syndrome

1; 2

Eligibility Criteria

• Age: 20 Years - 70 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suffering from CPPS over 3 months CPSI \>15

You may not qualify if:

• Patient with prior radical prostatectomy, rectal surgery, radiation therapy to the pelvic area, spinal cord injury, prostate cancer, bladder cancer, or known interstitial cystitis.
• Have major depression or any major psychogenic disorders.
• Patients with penile implant.

Sponsors & Collaborators

• National Taiwan University: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Related Publications (3)

• Sokolakis I, Hatzichristodoulou G. Clinical studies on low intensity extracorporeal shockwave therapy for erectile dysfunction: a systematic review and meta-analysis of randomised controlled trials. Int J Impot Res. 2019 May;31(3):177-194. doi: 10.1038/s41443-019-0117-z. Epub 2019 Jan 21.

  PMID: 30664671 BACKGROUND

• Campbell JD, Trock BJ, Oppenheim AR, Anusionwu I, Gor RA, Burnett AL. Meta-analysis of randomized controlled trials that assess the efficacy of low-intensity shockwave therapy for the treatment of erectile dysfunction. Ther Adv Urol. 2019 Mar 29;11:1756287219838364. doi: 10.1177/1756287219838364. eCollection 2019 Jan-Dec.

  PMID: 30956690 BACKGROUND

• Dong L, Chang D, Zhang X, Li J, Yang F, Tan K, Yang Y, Yong S, Yu X. Effect of Low-Intensity Extracorporeal Shock Wave on the Treatment of Erectile Dysfunction: A Systematic Review and Meta-Analysis. Am J Mens Health. 2019 Mar-Apr;13(2):1557988319846749. doi: 10.1177/1557988319846749.

  PMID: 31027441 BACKGROUND

Study Officials

• Fu-Shun Hsu, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: While subjects receive Sham therapy, the machine turning on but the energy is zero.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: We prospectively assessed the clinical outcome of LI-ESWT for the treatment of CPPS. This study was approved by the institutional review board at National Taiwan University Hospital (NTUH, No. T-NTUH-57401).

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 10, 2019
• Study Start: October 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: May 30, 2020
• Last Updated: July 10, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)