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

NCT04014036 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-07-10

No results posted yet for this study

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

Interventions

DEVICE

low energy extracorporeal shockwave therapy

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

Sponsors & Collaborators

  • National Taiwan University

    lead OTHER

Principal Investigators

  • Fu-Shun Hsu, MD · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2020-03-30
Completion
2020-05-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04014036 on ClinicalTrials.gov