NCT04014036

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

Treatment of Chronic Prostatitis/ Pelvic Pain Syndrome With Low-intensity Extracorporeal Shockwave Therapy: A Prospective, Randomized, Single-blind, Cross-over Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: National Taiwan University · Academic / Other
• Sex: Male
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The use of LI-ESWT has been increasingly proposed as a treatment for CPPS over the last decade. Overall, most of these studies reported encouraging results, regardless of variation in LI-ESWT set-up parameters or treatment protocols. As a whole these studies suggest that LI-ESWT could significantly improve the CPSI score and pain symptoms of CPPS patients. However, no randomized control trial with cross-over designed studies so far. This is a prospective, randomized, single-blind, cross-over clinical study. This study will be performed in outpatient setting of NTUH. Written informed consent will be given by all participants before entering the study. The subjects are treated at the therapy room of the department of urology, NTUH. All subjects would not pay any cost for this treatment/study. This study was approved by the institutional review board at National Taiwan University Hospital (NTUH, No. T-NTUH-57401). Inclusion criteria: were patient age 20 \~ 70 year-old man, suffering from CPPS for over 3 months, and CPSI \>15. The written informed consent forms from all subjects who met the inclusion criteria were obtained. Exclusion criteria: Patients with penile implant, prior radical prostatectomy, rectal surgery, radiation therapy to the pelvic area, spinal cord injury, prostate cancer, bladder cancer, interstitial cystitis, or major depression were excluded. Measurement of outcomes Primary outcome: the 4th week and the 8th week change from baseline for CPSI score. Secondary outcomes: International Index of Erectile Function Questionnaires (IIEF) at 4th and 8th week, QoL; AEs Methodology: All patients diagnosed of CPPS will be treated at out-patient clinic. 30 subjects receive LI-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). LI-ESWT is delivered by a probe that was attached to a electrohydraulic unit with a wide-focused shockwave source. The shockwaves are delivered at perineum area. The duration of each ESWT session is about 20 minutes, and comprised 3000 pulses (0.05mJ/mm2), and a frequency of 100/min. After 3 weeks, the two groups are cross over. Safety Considerations The peri- and post-treatment adverse events (AEs), including local pain, edema or hematoma were recorded and compared. With consideration of safety issue, any moderate/severe local pain or hematoma would be immediately reported and well inspected. Follow-up The following parameters are assessed before treatment and weekly during the treatment: CPSI score, IIEF, QoL; AEs.

Conditions

• Chronic Prostatitis/ Pelvic Pain Syndrome

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-03-30
• Completion: 2020-05-30
• First posted: 2019-07-10
• Last updated: 2019-07-10

Locations

1 site across 1 country: Taiwan