An Early Phase 1 interventional study of Bladder chemodenervation (Botox) and Bladder Sham (Saline) Injection Procedure in Spinal Cord Injuries, sponsored by University of Washington. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by University of Washington · Early Phase 1, Interventional, and Prevention
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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 10 is below the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BoNT-A (Botox) 200 U, will be injected into the detrusor (bladder wall muscle).
Drug: Bladder chemodenervation (Botox)
Saline will be injected into the detrusor (bladder wall muscle).
Procedure: Bladder Sham (Saline) Injection Procedure
BoNT-A (Botox) 200 U will be injected into the detrusor (bladder wall muscle).
20mL placebo (saline only), will be injected into the detrusor (bladder wall muscle).
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.
Time frame: Each participant will be evaluated for a period of up to 12 months after the time of enrollment.
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
Time frame: 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.
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.
Time frame: Variances of all measurements and data, for each subject, will be analyzed at the conclusion of their study participation, 12 months post enrollment.
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).
Time frame: Variances of all measurements and data will be analyzed at the conclusion of the study (expected in 2028).
Plan to share: No
Started Jul 2024 (actual). Primary completion is estimated for Apr 2028, 45 months after the start.
Of 40 non-industry phase 1 interventional studies under Spinal Cord Injuries, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 55. This study's planned 45 months is above that.
Counting every sponsor, half of 51 studies reached it within 36 months; a quarter within 24 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Botulinum toxin type A