Extracoporeal Shock Wave Therapy (ESWT) for the Treatment of Detrusor Underactivity/ Underactive Bladder (DU/UAB)

NCT04161183 | Completed

• 1 other identifier: 201900500A0
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of ESWT for the treatment of patients with DU/UAB

Conditions

Detrusor, Underactive; Detrusor Underactivity

Keywords

shock wave; detrusor underactivity; underactive bladder

Outcome Measures

Primary Outcomes (1)

• Net changes of the mean post void residual (PVR) volume (mL) from baseline to 1 month after the last treatment day

  Net changes of the PVR from baseline to 1 month after the last treatment day (higher PVR volumes represent a worse outcome)

  Baseline and 1 month

Secondary Outcomes (8)

• 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 Global response assessment (GRA)

  Baseline and 1 month

• Net changes of the maximum flow rate

  Baseline and 1 month

• Net changes of the voided volume

  Baseline and 1 month

• Net changes of the Pdet@Qmax

  Baseline and 1 month

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo treatment (shock wave probe w/o energy)

Device: Placebo

Extracoporeal shock wave therapy

EXPERIMENTAL

Extracoporeal shock wave therapy (shock wave probe w/ energy)

Device: Extracoporeal shock wave therapy

Interventions

Extracoporeal shock wave therapy DEVICE

Probe be transcutaneous applied to the region of bladder dome, right upper lateral wall, right lower lateral wall, left upper lateral wall, and left lower lateral wall with 2500 shocks, frequency of 4 pulses per second and maximum total energy flow density 0.25 millijoule/mm2 once a week for 6 weeks

Extracoporeal shock wave therapy

Placebo DEVICE

Probe be transcutaneous applied to the region of bladder dome, right upper lateral wall, right lower lateral wall, left upper lateral wall, and left lower lateral wall with 2500 shocks, frequency of 4 pulses per second but no energy once a week for 6 weeks

Placebo

Eligibility Criteria

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

You may qualify if:

• Adult male or female, at least 20 years of age.
• History of UAB (defined as bothersome chronic incomplete bladder emptying) for at least 3 months documented in the medical record with recurring UAB symptoms.
• No UAB symptom relief (unresponsiveness) with previous used medications and/or other treatments.
• Voiding difficulty (complains of difficulty emptying the bladder).
• UAB consistent with diabetes, MS, Parkinson's disease, or aging idiopathic.
• Post void residual ≥ 100 mL.
• Bladder capacity \> 200 mL and \< 800 mL.
• Pressure flow Urodynamic testing demonstrating impaired detrusor contractility or areflexia without evidence of BOO, with maximum detrusor pressure Pdet at Qmax (Pdet@Qmax) of \< 20 cmH2O and Maximum flow rate (Qmax) \< 15 mL/sec for female, and BCI \< 100 and BOOI \< 40 for male.
• Total UAB Questionnaire Score ≥ 3.
• Females of child-bearing potential agree to use reliable birth control for the entire study duration.
• Willing and capable of understanding and complying with all requirements of the protocol, including proper completion of the voiding diaries and self-administered questionnaires.
• Free of active urinary tract infection.
• Free of bladder outlet obstruction on enrollment.
• Patient or his/her legally acceptable representative has signed the written informed consent form.
• Subject on clean intermittent catheterization (CIC) should have been on CIC for at least 1 month and should be able to void spontaneously and not be completely dependent on CIC.

You may not qualify if:

• Female patients who is pregnant, lactating, plans to become pregnant, or with child-bearing potential without contraception.
• Simultaneously participating in another investigational drug or device study or use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment
• Has been treated with an investigational device, drug, or procedure for UAB within the last 3 months.
• History of cancer in pelvic organs, ureters, or kidneys or any cancer that has undergone treatment within the past 12 months.
• Medical condition or disorder that may limit life expectancy or that may cause protocol deviations (e.g. unable to perform self-evaluations/accurately report medical history, and/or urinary symptoms).
• History of spinal cord injury affecting urinary function.
• Patients with uncontrolled acute urinary tract infection. An active urinary tract infection as evidenced by positive urine culture at the time of baseline assessment. If a UTI is confirmed in the baseline sample (e.g., positive urine culture containing \> 100,000 cfu/mL in midstream urine), the run-in period should be stopped. After successful treatment of the UTI, the patient can be rescreened and if eligible enroll in the study. If the patient has asymptomatic bacteriuria (i.e., a positive urine culture without clinical signs and symptoms of a UTI), the patient should not be excluded.
• Currently taking medication(s) that may affect urination, including prescription drugs (i.e. anticholinergics, tricyclic antidepressants, bethanechol), over the counter drugs, dietary and/or herbal supplements, adrenergic antagonists. Alpha adrenergic blockers are allowed to use in a stable condition (longer than 1 month and keeping use during the study period).
• Pelvic organ prolapses beyond the introitus (e.g., cystocele, rectocele).
• Prior mesh surgery for stress urinary incontinence or pelvic prolapse.
• Any other condition which per investigators' judgement, may affect the patient's safety (e.g. significant cardiovascular disease, asthma or other breathing disorders).
• Patients with bladder outlet obstruction on enrollment.
• Patients with any contraindication to be urethral catheterization during diagnostic test or treatment or follow-up period.
• Patients have laboratory abnormalities at screening including:
• ALT \> 3 x upper limit of normal range AST \> 3 x upper limit of normal range Serum creatinine level \> 2 x upper limit of normal range.

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 (18)

• Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.

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• Miyazato M, Yoshimura N, Chancellor MB. The other bladder syndrome: underactive bladder. Rev Urol. 2013;15(1):11-22.

  PMID: 23671401 BACKGROUND

• Chuang YC, Plata M, Lamb LE, Chancellor MB. Underactive Bladder in Older Adults. Clin Geriatr Med. 2015 Nov;31(4):523-33. doi: 10.1016/j.cger.2015.06.002. Epub 2015 Jul 26.

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• Osman NI, Chapple CR, Abrams P, Dmochowski R, Haab F, Nitti V, Koelbl H, van Kerrebroeck P, Wein AJ. Detrusor underactivity and the underactive bladder: a new clinical entity? A review of current terminology, definitions, epidemiology, aetiology, and diagnosis. Eur Urol. 2014 Feb;65(2):389-98. doi: 10.1016/j.eururo.2013.10.015. Epub 2013 Oct 26.

  PMID: 24184024 BACKGROUND

• Brierly RD, Hindley RG, McLarty E, Harding DM, Thomas PJ. A prospective controlled quantitative study of ultrastructural changes in the underactive detrusor. J Urol. 2003 Apr;169(4):1374-8. doi: 10.1097/01.ju.0000055781.07630.aa.

  PMID: 12629365 BACKGROUND

• Elbadawi A, Yalla SV, Resnick NM. Structural basis of geriatric voiding dysfunction. II. Aging detrusor: normal versus impaired contractility. J Urol. 1993 Nov;150(5 Pt 2):1657-67. doi: 10.1016/s0022-5347(17)35867-6.

  PMID: 8411454 BACKGROUND

• Jiang YH, Kuo HC. Urothelial Barrier Deficits, Suburothelial Inflammation and Altered Sensory Protein Expression in Detrusor Underactivity. J Urol. 2017 Jan;197(1):197-203. doi: 10.1016/j.juro.2016.07.071. Epub 2016 Jul 17.

  PMID: 27436428 BACKGROUND

• Cho KJ, Koh JS, Choi J, Kim JC. Changes in Adenosine Triphosphate and Nitric Oxide in the Urothelium of Patients with Benign Prostatic Hyperplasia and Detrusor Underactivity. J Urol. 2017 Dec;198(6):1392-1396. doi: 10.1016/j.juro.2017.06.080. Epub 2017 Jun 24.

  PMID: 28655527 BACKGROUND

• Andersson KE. Detrusor underactivity/underactive bladder: new research initiatives needed. J Urol. 2010 Nov;184(5):1829-30. doi: 10.1016/j.juro.2010.08.048. Epub 2010 Sep 17. No abstract available.

  PMID: 20846686 BACKGROUND

• Osman NI, Esperto F, Chapple CR. Detrusor Underactivity and the Underactive Bladder: A Systematic Review of Preclinical and Clinical Studies. Eur Urol. 2018 Nov;74(5):633-643. doi: 10.1016/j.eururo.2018.07.037. Epub 2018 Aug 20.

  PMID: 30139634 BACKGROUND

• Wang HJ, Cheng JH, Chuang YC. Potential applications of low-energy shock waves in functional urology. Int J Urol. 2017 Aug;24(8):573-581. doi: 10.1111/iju.13403. Epub 2017 Jul 11.

  PMID: 28697536 BACKGROUND

• Chuang YC, Tyagi P, Wang HJ, Huang CC, Lin CC, Chancellor MB. Urodynamic and molecular characteristics of detrusor underactivity in a rat cryoinjury model and effects of low energy shock wave therapy. Neurourol Urodyn. 2018 Feb;37(2):708-715. doi: 10.1002/nau.23381. Epub 2017 Aug 2.

  PMID: 28767169 BACKGROUND

• Chuang YC, Tyagi P, Luo HL, Lee WC, Wang HJ, Huang CC, Chancellor MB. Long-term functional change of cryoinjury-induced detrusor underactivity and effects of extracorporeal shock wave therapy in a rat model. Int Urol Nephrol. 2019 Apr;51(4):617-626. doi: 10.1007/s11255-019-02095-4. Epub 2019 Feb 22.

  PMID: 30796726 BACKGROUND

• Wang HS, Oh BS, Wang B, Ruan Y, Zhou J, Banie L, Lee YC, Tamaddon A, Zhou T, Wang G, Lin G, Lue TF. Low-intensity extracorporeal shockwave therapy ameliorates diabetic underactive bladder in streptozotocin-induced diabetic rats. BJU Int. 2018 Sep;122(3):490-500. doi: 10.1111/bju.14216. Epub 2018 Apr 20.

  PMID: 29603534 BACKGROUND

• Zissler A, Steinbacher P, Zimmermann R, Pittner S, Stoiber W, Bathke AC, Sanger AM. Extracorporeal Shock Wave Therapy Accelerates Regeneration After Acute Skeletal Muscle Injury. Am J Sports Med. 2017 Mar;45(3):676-684. doi: 10.1177/0363546516668622. Epub 2016 Oct 13.

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• Wang B, Zhou J, Banie L, Reed-Maldonado AB, Ning H, Lu Z, Ruan Y, Zhou T, Wang HS, Oh BS, Wang G, Qi SL, Lin G, Lue TF. Low-intensity extracorporeal shock wave therapy promotes myogenesis through PERK/ATF4 pathway. Neurourol Urodyn. 2018 Feb;37(2):699-707. doi: 10.1002/nau.23380. Epub 2017 Aug 1.

  PMID: 28763567 BACKGROUND

• Uren AD, Cotterill N, Harding C, Hillary C, Chapple C, Klaver M, Bongaerts D, Hakimi Z, Abrams P. Qualitative Exploration of the Patient Experience of Underactive Bladder. Eur Urol. 2017 Sep;72(3):402-407. doi: 10.1016/j.eururo.2017.03.045. Epub 2017 Apr 8.

  PMID: 28400168 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

Related Links

• Astellas Pharma Inc (Astellas Pharma Europe B.V.). A Study of ASP8302 in Participants With Underactive Bladder. ClinicalTrials.gov Identifier: NCT03702777

MeSH Terms

Conditions

Urinary Bladder, Underactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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 patients 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 (ESWT and Placebo) in 1: 1 ratio as shown below. The ESWT 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: November 10, 2019
• First Posted: November 13, 2019
• Study Start: October 15, 2019
• Primary Completion: December 1, 2021
• Study Completion: August 10, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-03

Locations

TW (1)