Low Energy Shock Wave for the Treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
Low Energy Shock Wave for the Treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
To investigate the efficacy and safety of LESW on participants with IC/BPS
Low energy shock wave (LESW) is known to facilitate tissue regeneration with analgesic and
 anti-inflammatory effects. LESW has been proved to have therapeutic effects in patients with
 nonbacterial prostatitis and chronic pelvic pain syndrome (CPPS). Investigator's previous
 study has demonstrated that LESW treatment inhibited nerve growth factor (NGF), interleukin-6
 (IL-6), and cyclooxygenase-2 (COX-2) expression, and blocked the bladder pain, inflammation
 and overactivity in a cyclophosphamide induced cystitis model in rats. These findings suggest
 that a potential clinical benefit of LESW treatment for patients with interstitial
 cystitis/bladder pain syndrome (IC/BPS).

 A total of 50 participants with IC/BPS will be enrolled to receive LESW (transcutaneous
 applied to the suprapubic bladder region with 2000 shocks, frequency of 3 pulses per second
 and maximum total energy flow density 0.25 millijoule/mm2) once a week for 4 weeks or placebo
 (same condition but with no energy) treatment.

 All participants should have IC symptoms for at least 6 months, and have received cystoscopy
 to rule out other bladder lesion. Participants should not have urinary tract infection (UTI)
 in recent 3 months, and no urinary tract stone. Participants should not receive intravesical
 hyaluronic acid treatment in recent 3 months, or intravesical Botox injection in recent 12
 months. Retreatment with LESW at 3 months if participants reports ineffective.

 Primary end-point is the change of the O'Leary-Sant symptom score (OSS), including
 Interstitial Cystitis Symptom Index (ICSI) and Interstitial Cystitis Problem Index (ICPI)
 from baseline to 1 month after treatment. Secondary endpoints include Visual Analogue Scale
 (VAS), daily frequency, nocturia and functional bladder capacity (FBC) as record in 3-day
 voiding diary, maximum flow rate (Qmax), voided volume, postvoiding residual (PVR) and global
 response assessment (GRA). Two visits are required at baseline screening (before first
 treatment), treatment (V1), 1 week (V2), 2 weeks (V3), 3 weeks (V4) and 1 week post V4
 treatment (V5), 1 month post V4 treatment (V6, primary end-point), and 3 months post V4
 treatment (V7) . Urine samples will be collected at each time-point for NGF and cytokines
 tests. Bladder biopsy will be performed at baseline and repeat cystoscopy at 3 months post
 treatment optional.
Inclusion Criteria:

 1. Adults with age of 20 years old or above

 2. Patients with symptoms of unpleasant sensation (pain, pressure, discomfort) perceived
 to be related to the urinary bladder, associated with lower urinary tract symptoms of
 more than six months duration, in the absence of infection or other identifiable
 causes

 3. Patients has received cystoscopy and ruled out other bladder lesion

 4. Free of active urinary tract infection

 5. Free of bladder outlet obstruction on enrollment

 6. Free of overt neurogenic bladder dysfunction and limitation of ambulation

 7. Patient or his/her legally acceptable representative has signed the written informed
 consent form

 Exclusion Criteria:

 1. Patients had received intravesical hyaluronic acid treatment in recent 3 months, or
 intravesical Botox injection in recent 12 months Patients with severe cardiopulmonary
 disease and such as congestive heart failure, arrhythmia, poorly controlled
 hypertension, not able to receive regular follow-up

 2. Patients with bladder outlet obstruction on enrollment

 3. Patients with PVR >100 ml

 4. Patients with uncontrolled confirmed diagnosis of acute urinary tract infection

 5. Patients have laboratory abnormalities at screening including: alanine
 aminotransferase (ALT)> 3 x upper limit of normal range, and aspartate
 aminotransferase (AST) > 3 x upper limit of normal range

 6. Patients have abnormal serum creatinine level > 2 x upper limit of normal range

 7. Female patients who is pregnant, lactating, or with child-bearing potential without
 contraception

 8. Patients with any other serious disease considered by the investigator not in the
 condition to enter the trial

 9. Patients had received intravesical treatment for IC within recent 1 month

 10. Patients had participated investigational drug trial within 1 month before entering
 this study

 11. Patients with coagulopathy