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