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

NCT03619486 | Completed

• 1 other identifier: 201800525A3
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the efficacy and safety of LESW on participants with IC/BPS

Conditions

Interstitial Cystitis

Keywords

Low Energy Shock Wave (LESW); Extracorporeal Shockwave Therapy; interstitial cystitis/bladder pain syndrome (IC/BPS)

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline and 1 month

Secondary Outcomes (9)

• Net changes of the Visual Analog Scale (VAS)

  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

  Baseline and 1 month

• Net changes of the voiding frequency at daytime as recorded in 3-day voiding diary

  Baseline and 1 month

• Net changes of the voiding frequency at night time as recorded in 3-day voiding diary

  Baseline and 1 month

• Net changes of the Global response assessment (GRA)

  Baseline and 3 month

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo treatment (shock wave probe w/o energy)

Device: Placebo

Low energy shock wave

EXPERIMENTAL

Low energy shock wave treatment (shock wave probe w/ energy)

Device: Low energy shock wave

Interventions

Low energy shock wave DEVICE

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

Low energy shock wave

Placebo DEVICE

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

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with age of 20 years old or above
• 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
• Patients has received cystoscopy and ruled out other bladder lesion
• Free of active urinary tract infection
• Free of bladder outlet obstruction on enrollment
• Free of overt neurogenic bladder dysfunction and limitation of ambulation
• Patient or his/her legally acceptable representative has signed the written informed consent form

You may not qualify if:

• 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
• Patients with bladder outlet obstruction on enrollment
• Patients with PVR \>100 ml
• Patients with uncontrolled confirmed diagnosis of acute urinary tract infection
• 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
• Patients have abnormal serum creatinine level \> 2 x upper limit of normal range
• Female patients who is pregnant, lactating, or with child-bearing potential without contraception
• Patients with any other serious disease considered by the investigator not in the condition to enter the trial
• Patients had received intravesical treatment for IC within recent 1 month
• Patients had participated investigational drug trial within 1 month before entering this study
• Patients with coagulopathy

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital, Chang Gung University College of Medicine

Kaohsiung City, 833, Taiwan

Location

Related Publications (19)

• 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.

  PMID: 21497847 BACKGROUND

• 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.

  PMID: 11378041 BACKGROUND

• 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.

  PMID: 15833501 BACKGROUND

• 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.

  PMID: 2926877 BACKGROUND

• 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.

  PMID: 15126772 BACKGROUND

• 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.

  PMID: 25623737 BACKGROUND

• 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.

  PMID: 15013658 BACKGROUND

• 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.

  PMID: 22310775 BACKGROUND

• 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.

  PMID: 21813166 BACKGROUND

• 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.

  PMID: 6977650 BACKGROUND

• Wang CJ. An overview of shock wave therapy in musculoskeletal disorders. Chang Gung Med J. 2003 Apr;26(4):220-32.

  PMID: 12846521 BACKGROUND

• 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.

  PMID: 21790971 BACKGROUND

• 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.

  PMID: 22425129 BACKGROUND

• 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.

  PMID: 19601786 BACKGROUND

• 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.

  PMID: 28035695 BACKGROUND

• 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.

  PMID: 19372000 BACKGROUND

• 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.

  PMID: 28119778 BACKGROUND

• 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.

  PMID: 32394478 RESULT

• 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.

  PMID: 32734597 DERIVED

MeSH Terms

Conditions

Cystitis, Interstitial

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Tsang-Tang Hsieh, MD

  Institutional Review Board Chang Gung Medical Foundation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 19, 2018
• First Posted: August 8, 2018
• Study Start: July 4, 2018
• Primary Completion: February 26, 2020
• Study Completion: June 30, 2020
• Last Updated: February 1, 2021

Record last verified: 2021-01

Locations

TW (1)