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Low Energy Shock Wave for the Treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)

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ClinicalTrials.gov Identifier: NCT03619486
Recruitment Status : Completed
First Posted : August 8, 2018
Last Update Posted : February 1, 2021
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Study Description
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Brief Summary:
To investigate the efficacy and safety of LESW on participants with IC/BPS

Condition or disease Intervention/treatment Phase
Interstitial Cystitis Device: Low energy shock wave Device: Placebo Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind, placebo control study. Eligible participants will be assigned a randomization number in sequential order and each of the randomization will determine the allocation of one of the two treatment groups (LESW and Placebo) in 1: 1 ratio as shown below. The LESW and placebo will be controlled by a research assistance who will not evaluate the therapeutic outcome to ensure the double blind method.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Low Energy Shock Wave for the Treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) - a Randomized, Double-blind, Placebo-controlled, Prospective Study
Actual Study Start Date : July 4, 2018
Actual Primary Completion Date : February 26, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo treatment (shock wave probe w/o energy)
 Device: Placebo
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
Experimental: Low energy shock wave
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


Outcome Measures
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Primary Outcome Measures :
  1. Change of the O'Leary-Sant symptom score (OSS, including ICSI and ICPI) [ Time Frame: Baseline and 1 month ]

    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).



Secondary Outcome Measures :
  1. Net changes of the Visual Analog Scale (VAS) [ Time Frame: Baseline and 1 month ]
    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)

  2. Net changes of the functional bladder capacity (FBC) as assessed by the maximum urine volume (milliliters) as recorded in 3-day voiding diary [ Time Frame: Baseline and 1 month ]
    Net changes of the functional bladder capacity (FBC) from baseline to 1 month after the treatment day (higher FBC volumes represent a better outcome)

  3. Net changes of the voiding frequency at daytime as recorded in 3-day voiding diary [ Time Frame: Baseline and 1 month ]
    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)

  4. Net changes of the voiding frequency at night time as recorded in 3-day voiding diary [ Time Frame: Baseline and 1 month ]
    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)

  5. Net changes of the Global response assessment (GRA) [ Time Frame: Baseline and 3 month ]
    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

  6. Net changes of the maximum flow rate [ Time Frame: Baseline and 1 month ]
    Net changes of the maximum flow rate from baseline to 1 month after the treatment day (higher maximum flow rate represent a better outcome)

  7. Net changes of the voided volume [ Time Frame: Baseline and 1 month ]
    Net changes of the voided volume from baseline to 1 month after the treatment day (higher voided volumes represent a better outcome)

  8. Net changes of the PVR [ Time Frame: Baseline and 1 month ]
    Net changes of the PVR from baseline to 1 month after the treatment day (higher PVR volumes represent a worse outcome)

  9. Net changes of the cytokines level [ Time Frame: Baseline and 1 month ]
    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)


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619486


Locations
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Taiwan
Chang Gung Memorial Hospital, Chang Gung University College of Medicine
Kaohsiung, Taiwan, 833
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Chair: Tsang-Tang Hsieh, MD Institutional Review Board Chang Gung Medical Foundation
  Study Documents (Full-Text)

Documents provided by Chang Gung Memorial Hospital:
Study Protocol  [PDF] March 16, 2020
Statistical Analysis Plan  [PDF] March 16, 2020

More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03619486    
Other Study ID Numbers: 201800525A3
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: February 1, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
Low Energy Shock Wave (LESW)
Extracorporeal Shockwave Therapy
interstitial cystitis/bladder pain syndrome (IC/BPS)
Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases