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Spinal Cord InjuriesEarly Phase 1NCT06793683

Early BOTOX After Spinal Cord Injury

A Early Phase 1 study testing Bladder chemodenervation (Botox) in people with Spinal Cord Injuries, run by University of Washington at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The investigators would like to improve our understanding of how early intervention with the use of bladder chemodenervation can preserve bladder function in those with a new SCI. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Spinal Cord Injuries
What is being tested?
Bladder chemodenervation (Botox)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
1 siteUnited States
Study dates
27 Jul 2024to 30 Sep 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female 18-65 years of age at time of SCI.
  • 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.

Who cannot join

  • Inability to return to research site (Harborview Medical Center) for follow-up studies after initial hospitalization.
  • 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.
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Harborview Medical Center

    Seattle, Washington, 98104

Other trials in United States

About this study

Official title: Early Detrusor Chemodenervation to Preserve Bladder Compliance and Longevity After Spinal Cord Injury

The investigators would like to improve our understanding of how early intervention with the use of bladder chemodenervation can preserve bladder function in those with a new SCI. Although detrimental cystometric and tissue changes are known to occur, often within 3 months after SCI, the investigators seek to document the time course of these changes and the range of severity of those changes in both those participants that receive prophylactic treatment and those who do not.

Being tested
Bladder chemodenervation (Botox), Bladder Sham (Saline) Injection Procedure
Keywords
SCI, Neurogenic Bladder, Chemodenervation with BoNT-A, Botox, Autonomic Dysreflexia
Medical subject headings
Spinal Cord Injuries, Urinary Bladder, Neurogenic, Autonomic Dysreflexia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bladder chemodenervation (Botox)Drug

    BoNT-A (Botox) 200 U will be injected into the detrusor (bladder wall muscle).

  • Bladder Sham (Saline) Injection ProcedureProcedure or surgery

    20mL placebo (saline only), will be injected into the detrusor (bladder wall muscle).

Study groups in NCT06793683
Study groupRoleWhat they receive
Bladder Chemodenervation (Botox) Injection ProcedureActive comparatorBoNT-A (Botox) 200 U, will be injected into the detrusor (bladder wall muscle).
Receives: Drug: Bladder chemodenervation (Botox)
Bladder Sham (saline) Injection ProcedureSham comparatorSaline will be injected into the detrusor (bladder wall muscle).
Receives: Procedure: Bladder Sham (Saline) Injection Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of Enrollment goals

    Outcomes of this pilot trial will provide human data on the feasibility of recruiting 10 participants into a randomized study of early chemodenervation.

    The enrollment goal is 10 participants who will complete the 12-month study protocol.

    If ≥ 8 participants complete the protocol, it will be considered feasible. If ≤ 5 participants complete the protocol, it will be considered unfeasible. If 6-7 participants complete the study, it will be considered indeterminate.

    Measured: Each participant will be evaluated for a period of up to 12 months after the time of enrollment.

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Patients will be monitored for adverse events as a result of the procedures.

    • Evidence of Urinary Tract Infections
    • Hematuria
    • Anesthesia Complications

    Any adverse events (AE) will be graded 1 through 5, with unique clinical descriptions of severity for each AE, based upon the AE guidelines as published in the CAE v4.0

    Measured: For each participant any AE's will be documented, at time of AE, beginning at study enrollment and throughout each participants 12 month enrollment period.

Secondary outcomes (2)

  1. Variance of measurements for functional data

    Determination of variance of measurements for functional data, including:

    Cystometric values will be analyzed as a continuous variable and compared between early detrusor oBoNT-A injected cases and controls at the 6- and 12-month time points. Standard clinical care characterizes bladder compliance as poor for values <10 mL/cm H2O, indeterminate for values between 10 mL/cm H2O and 20 mL/cm H2O, and good for values >20 mL/cm H2O. To interpret our data, we will use these existing clinical guidelines in concert with statistical differences that arise.

    Measured: Variances of all measurements and data, for each subject, will be analyzed at the conclusion of their study participation, 12 months post enrollment.

  2. Variance of measurements for histological data

    Determination of variance of measurements for histological data, including:

    Histological analyses of the bladder biopsy samples will include standard histological staining to evaluate hypertrophy and fibrosis, and how these parameters change with time (baseline, 6 months and 12 months post SCI).

    Measured: Variances of all measurements and data will be analyzed at the conclusion of the study (expected in 2028).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2025
  2. Study start27 Jul 2024
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
The investigators hope to recruit 10 participants randomly assigned to 7 cases (those that will receive Botox bladder injections) and 3 controls (those that will receive placebo bladder injections).
Masking
Single blind
Who is masked
Participant
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06793683
Sponsor's protocol ID
STUDY00018758
Other IDs
CDMRP- SC220183
Status last verified
May 2026
First submitted
6 Dec 2024
Last updated
9 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 16517054

  • 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.

    PubMed 22503020

  • 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.

    PubMed 16317536

  • 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.

    PubMed 9776015

  • 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.

    PubMed 29352989

  • 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.

    PubMed 37096828

  • 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.

    PubMed 24518764

  • 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.

    PubMed 24708598

  • 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.

    PubMed 36356027

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Bladder chemodenervation (Botox) in people with Spinal Cord Injuries, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Enrollment goals (time frame: Each participant will be evaluated for a period of up to 12 months after the time of enrollment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06793683, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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