An interventional study of Low energy shock wave and Placebo in Interstitial Cystitis, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-02-01.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
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.
235 studies on the registry are indexed under Cystitis; 22 are open to participants now.
This study's enrollment of 49 is below the median of 60 across 170 interventional studies indexed under Cystitis.
Browse Cystitis studies →Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
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Exclusion Criteria:
Placebo treatment (shock wave probe w/o energy)
Device: Placebo
Low energy shock wave treatment (shock wave probe w/ energy)
Device: Low energy shock wave
Probe be 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
Probe be transcutaneous applied to the suprapubic bladder region with 2000 shocks, frequency of 3 pulses per second but no energy once a week for 4 weeks
Change of the O'Leary-Sant symptom score (OSS, including ICSI and ICPI)
Change of the O'Leary-Sant symptom score from baseline to 1 month after the treatment day. Subscales ICSI and ICPI are graded from 0 to 20 and 0 to 16, respectively. The items are summed to obtain OSS (range from 0 to 36, higher values represent a worse outcome).
Time frame: Baseline and 1 month
Net changes of the Visual Analog Scale (VAS)
Net changes of the Visual Analog Scale from baseline to 1 month after the treatment day (VAS range from 0 to 10, higher values represent a worse outcome)
Time frame: Baseline and 1 month
Net changes of the functional bladder capacity (FBC) as assessed by the maximum urine volume (milliliters) as recorded in 3-day voiding diary
Net changes of the functional bladder capacity (FBC) from baseline to 1 month after the treatment day (higher FBC volumes represent a better outcome)
Time frame: Baseline and 1 month
Net changes of the voiding frequency at daytime as recorded in 3-day voiding diary
Net changes of the voiding frequency at daytime as recorded in 3-day voiding diary from baseline to 1 month after the treatment day (higher voiding frequency at daytime represent a worse outcome)
Time frame: Baseline and 1 month
Net changes of the voiding frequency at night time as recorded in 3-day voiding diary
Net changes of the voiding frequency at night time as recorded in 3-day voiding diary from baseline to 1 month after the treatment day (higher voiding frequency at night time represent a worse outcome)
Time frame: Baseline and 1 month
Net changes of the Global response assessment (GRA)
Global response assessment (GRA) of therapeutic result by the patient (categorized from -3 to +3, indicating markedly worse to markedly improved) at 3 months after the last treatment day
Time frame: Baseline and 3 month
Net changes of the maximum flow rate
Net changes of the maximum flow rate from baseline to 1 month after the treatment day (higher maximum flow rate represent a better outcome)
Time frame: Baseline and 1 month
Net changes of the voided volume
Net changes of the voided volume from baseline to 1 month after the treatment day (higher voided volumes represent a better outcome)
Time frame: Baseline and 1 month
Net changes of the PVR
Net changes of the PVR from baseline to 1 month after the treatment day (higher PVR volumes represent a worse outcome)
Time frame: Baseline and 1 month
Net changes of the cytokines level
Net changes of the cytokines level from baseline to 1 month after the treatment day (e.g. NGF and IL-6, higher values represent a worse outcome)
Time frame: Baseline and 1 month
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Chang Gung Memorial Hospital