Low Energy Shock Wave for the Treatment of Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS)
NCT ID: NCT03619486
Last Updated: 2021-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
49 participants
INTERVENTIONAL
2018-07-04
2020-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo treatment (shock wave probe w/o energy)
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
Low energy shock wave
Low energy shock wave treatment (shock wave probe w/ energy)
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
ALL
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Principal Investigators
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Tsang-Tang Hsieh, MD
Role: STUDY_CHAIR
Institutional Review Board Chang Gung Medical Foundation
Locations
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Chang Gung Memorial Hospital, Chang Gung University College of Medicine
Kaohsiung City, , Taiwan
Countries
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References
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Hanno PM, Burks DA, Clemens JQ, Dmochowski RR, Erickson D, Fitzgerald MP, Forrest JB, Gordon B, Gray M, Mayer RD, Newman D, Nyberg L Jr, Payne CK, Wesselmann U, Faraday MM; Interstitial Cystitis Guidelines Panel of the American Urological Association Education and Research, Inc. AUA guideline for the diagnosis and treatment of interstitial cystitis/bladder pain syndrome. J Urol. 2011 Jun;185(6):2162-70. doi: 10.1016/j.juro.2011.03.064. Epub 2011 Apr 16.
Hanno PM, Sant GR. Clinical highlights of the National Institute of Diabetes and Digestive and Kidney Diseases/Interstitial Cystitis Association scientific conference on interstitial cystitis. Urology. 2001 Jun;57(6 Suppl 1):2-6. doi: 10.1016/s0090-4295(01)01112-8.
Nickel JC, Barkin J, Forrest J, Mosbaugh PG, Hernandez-Graulau J, Kaufman D, Lloyd K, Evans RJ, Parsons CL, Atkinson LE; Elmiron Study Group. Randomized, double-blind, dose-ranging study of pentosan polysulfate sodium for interstitial cystitis. Urology. 2005 Apr;65(4):654-8. doi: 10.1016/j.urology.2004.10.071.
Hanno PM, Buehler J, Wein AJ. Use of amitriptyline in the treatment of interstitial cystitis. J Urol. 1989 Apr;141(4):846-8. doi: 10.1016/s0022-5347(17)41029-9.
Sairanen J, Forsell T, Ruutu M. Long-term outcome of patients with interstitial cystitis treated with low dose cyclosporine A. J Urol. 2004 Jun;171(6 Pt 1):2138-41. doi: 10.1097/01.ju.0000125139.91203.7a.
Hanno PM, Erickson D, Moldwin R, Faraday MM; American Urological Association. Diagnosis and treatment of interstitial cystitis/bladder pain syndrome: AUA guideline amendment. J Urol. 2015 May;193(5):1545-53. doi: 10.1016/j.juro.2015.01.086. Epub 2015 Jan 23.
Chancellor MB, Yoshimura N. Treatment of interstitial cystitis. Urology. 2004 Mar;63(3 Suppl 1):85-92. doi: 10.1016/j.urology.2003.10.034.
Shie JH, Liu HT, Kuo HC. Increased cell apoptosis of urothelium mediated by inflammation in interstitial cystitis/painful bladder syndrome. Urology. 2012 Feb;79(2):484.e7-13. doi: 10.1016/j.urology.2011.09.049.
Lee JD, Lee MH. Increased expression of hypoxia-inducible factor-1alpha and vascular endothelial growth factor associated with glomerulation formation in patients with interstitial cystitis. Urology. 2011 Oct;78(4):971.e11-5. doi: 10.1016/j.urology.2011.05.050. Epub 2011 Aug 2.
Chaussy C, Schmiedt E, Jocham D, Brendel W, Forssmann B, Walther V. First clinical experience with extracorporeally induced destruction of kidney stones by shock waves. J Urol. 1982 Mar;127(3):417-20. doi: 10.1016/s0022-5347(17)53841-0.
Wang CJ. An overview of shock wave therapy in musculoskeletal disorders. Chang Gung Med J. 2003 Apr;26(4):220-32.
Di Meglio F, Nurzynska D, Castaldo C, Miraglia R, Romano V, De Angelis A, Piegari E, Russo S, Montagnani S. Cardiac shock wave therapy: assessment of safety and new insights into mechanisms of tissue regeneration. J Cell Mol Med. 2012 Apr;16(4):936-42. doi: 10.1111/j.1582-4934.2011.01393.x.
Vardi Y, Appel B, Kilchevsky A, Gruenwald I. Does low intensity extracorporeal shock wave therapy have a physiological effect on erectile function? Short-term results of a randomized, double-blind, sham controlled study. J Urol. 2012 May;187(5):1769-75. doi: 10.1016/j.juro.2011.12.117. Epub 2012 Mar 15.
Mariotto S, de Prati AC, Cavalieri E, Amelio E, Marlinghaus E, Suzuki H. Extracorporeal shock wave therapy in inflammatory diseases: molecular mechanism that triggers anti-inflammatory action. Curr Med Chem. 2009;16(19):2366-72. doi: 10.2174/092986709788682119.
Wang HJ, Lee WC, Tyagi P, Huang CC, Chuang YC. Effects of low energy shock wave therapy on inflammatory moleculars, bladder pain, and bladder function in a rat cystitis model. Neurourol Urodyn. 2017 Aug;36(6):1440-1447. doi: 10.1002/nau.23141. Epub 2016 Dec 30.
Zimmermann R, Cumpanas A, Miclea F, Janetschek G. Extracorporeal shock wave therapy for the treatment of chronic pelvic pain syndrome in males: a randomised, double-blind, placebo-controlled study. Eur Urol. 2009 Sep;56(3):418-24. doi: 10.1016/j.eururo.2009.03.043. Epub 2009 Mar 25.
Al Edwan GM, Muheilan MM, Atta ON. Long term efficacy of extracorporeal shock wave therapy [ESWT] for treatment of refractory chronic abacterial prostatitis. Ann Med Surg (Lond). 2017 Jan 6;14:12-17. doi: 10.1016/j.amsu.2016.12.051. eCollection 2017 Feb.
Chuang YC, Meng E, Chancellor M, Kuo HC. Pain reduction realized with extracorporeal shock wave therapy for the treatment of symptoms associated with interstitial cystitis/bladder pain syndrome-A prospective, multicenter, randomized, double-blind, placebo-controlled study. Neurourol Urodyn. 2020 Jun;39(5):1505-1514. doi: 10.1002/nau.24382. Epub 2020 May 11.
Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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201800525A3
Identifier Type: -
Identifier Source: org_study_id
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