Study Results
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Basic Information
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ENROLLING_BY_INVITATION
EARLY_PHASE1
10 participants
INTERVENTIONAL
2024-07-27
2028-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Bladder Chemodenervation (Botox) Injection Procedure
BoNT-A (Botox) 200 U, will be injected into the detrusor (bladder wall muscle).
Bladder chemodenervation (Botox)
BoNT-A (Botox) 200 U will be injected into the detrusor (bladder wall muscle).
Bladder Sham (saline) Injection Procedure
Saline will be injected into the detrusor (bladder wall muscle).
Bladder Sham (Saline) Injection Procedure
20mL placebo (saline only), will be injected into the detrusor (bladder wall muscle).
Interventions
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Bladder chemodenervation (Botox)
BoNT-A (Botox) 200 U will be injected into the detrusor (bladder wall muscle).
Bladder Sham (Saline) Injection Procedure
20mL placebo (saline only), will be injected into the detrusor (bladder wall muscle).
Eligibility Criteria
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Inclusion Criteria
* English speaking
* Recent SCI (within 20 weeks of injury).
* Documentation of a spinal cord injury at T6 or higher, American Spinal Injury Association Impairment Scale (AIS) level A or B as designated on initial (72 hour) AIS exam.
* Ability for subject to comply with the requirements of the study.
* Written informed consent obtained from subject.
Exclusion Criteria
* Acute (as part of concurrent hospitalization) or history of bladder surgery (urethral or prostate surgery acceptable) or injury.
* Inability to provide informed consent.
* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
* Incarcerated in a detention facility or in police custody.
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* Active medical problems precluding the safe conduct of urodynamics, bladder chemodenervation, bladder biopsy (e.g., evidence of active bladder infection, ruled out by urine culture prior to procedures)
* Known hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation
* Cardiovascular instability
18 Years
65 Years
ALL
No
Sponsors
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University of Washington
OTHER
Responsible Party
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Claire Yang, MD
Professor: Department of Urology
Principal Investigators
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Claire C Yang, MD
Role: PRINCIPAL_INVESTIGATOR
University of Washington
Locations
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Harborview Medical Center
Seattle, Washington, United States
Countries
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References
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Comperat E, Reitz A, Delcourt A, Capron F, Denys P, Chartier-Kastler E. Histologic features in the urinary bladder wall affected from neurogenic overactivity--a comparison of inflammation, oedema and fibrosis with and without injection of botulinum toxin type A. Eur Urol. 2006 Nov;50(5):1058-64. doi: 10.1016/j.eururo.2006.01.025. Epub 2006 Feb 6.
Ginsberg D, Gousse A, Keppenne V, Sievert KD, Thompson C, Lam W, Brin MF, Jenkins B, Haag-Molkenteller C. Phase 3 efficacy and tolerability study of onabotulinumtoxinA for urinary incontinence from neurogenic detrusor overactivity. J Urol. 2012 Jun;187(6):2131-9. doi: 10.1016/j.juro.2012.01.125. Epub 2012 Apr 12.
Ku JH, Choi WJ, Lee KY, Jung TY, Lee JK, Park WH, Shim HB. Complications of the upper urinary tract in patients with spinal cord injury: a long-term follow-up study. Urol Res. 2005 Dec;33(6):435-9. doi: 10.1007/s00240-005-0504-4. Epub 2005 Nov 30.
Janzen J, Vuong PN, Bersch U, Michel D, Zaech GA. Bladder tissue biopsies in spinal cord injured patients: histopathologic aspects of 61 cases. Neurourol Urodyn. 1998;17(5):525-30. doi: 10.1002/(sici)1520-6777(1998)17:53.0.co;2-f.
Bywater M, Tornic J, Mehnert U, Kessler TM. Detrusor Acontractility after Acute Spinal Cord Injury-Myth or Reality? J Urol. 2018 Jun;199(6):1565-1570. doi: 10.1016/j.juro.2018.01.046. Epub 2018 Jan 17.
Rosier PFWM, Valdevenito JP, Smith P, Sinha S, Speich J, Gammie A; Members of the ICS Working Group PFS23. ICS-SUFU standard: Theory, terms, and recommendations for pressure-flow studies performance, analysis, and reporting. Part 1: Background theory and practice. Neurourol Urodyn. 2023 Nov;42(8):1590-1602. doi: 10.1002/nau.25192. Epub 2023 Apr 25.
Welk B, Morrow S, Madarasz W, Baverstock R, Macnab J, Sequeira K. The validity and reliability of the neurogenic bladder symptom score. J Urol. 2014 Aug;192(2):452-7. doi: 10.1016/j.juro.2014.01.027. Epub 2014 Feb 8.
Tang DH, Colayco D, Piercy J, Patel V, Globe D, Chancellor MB. Impact of urinary incontinence on health-related quality of life, daily activities, and healthcare resource utilization in patients with neurogenic detrusor overactivity. BMC Neurol. 2014 Apr 4;14:74. doi: 10.1186/1471-2377-14-74.
Bushnell JY, Cates LN, Hyde JE, Hofstetter CP, Yang CC, Khaing ZZ. Early Detrusor Application of Botulinum Toxin A Results in Reduced Bladder Hypertrophy and Fibrosis after Spinal Cord Injury in a Rodent Model. Toxins (Basel). 2022 Nov 10;14(11):777. doi: 10.3390/toxins14110777.
Other Identifiers
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STUDY00018758
Identifier Type: -
Identifier Source: org_study_id
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