NCT06059066: BOND

Optimization of OnabotulinumtoxinA (BTX-A) Injection for the Treatment of Neurogenic Lower Urinary Tract Dysfunction

Completed NA Results posted Last updated 9 May 2025

What this trial tests

NA trial testing Standard number of injection sites in Neurogenic Bladder in 78 participants. Completed in 30 April 2024.

Timeline

4 October 2023

Primary endpoint
30 April 2024

30 April 2024

Quick facts

Lead sponsor	The Methodist Hospital Research Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	78
Start date	4 October 2023
Primary completion	30 April 2024
Estimated completion	30 April 2024
Sites	1 location across United States

Drugs / interventions tested

• Standard number of injection sites
• Reduced number of injection sites

Conditions studied

• Neurogenic Bladder — all drugs for Neurogenic Bladder →
• Lower Urinary Tract Symptoms — all drugs for Lower Urinary Tract Symptoms →
• Overactive Bladder — all drugs for Overactive Bladder →
• Neuro: Neurogenic Bladder — all drugs for Neuro: Neurogenic Bladder →

Sponsor

The Methodist Hospital Research Institute

Who can join

18 and older, any sex, with Neurogenic Bladder or Lower Urinary Tract Symptoms. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Willingness to Repeat Procedure Primary · Immediately post-procedure and 6 weeks post-procedure

Participants were asked to rate their willingness to repeat the procedure using an 11-point visual analog scale (VAS). A score of 0 ("Never") indicates complete unwillingness, representing the least favorable outcome, while a score of 11 ("Definitely") reflects strong willingness, representing the most favorable outcome.

Post-injection willingness to repeat procedure rating (VAS score)

Group	Value	95% CI
Standard Injection Sites (20)	9.16	± 1.46
Reduced Injection Sites (5)	9.34	± 1.26

6-weeks post-procedure willingness to repeat procedure rating (VAS score)

Group	Value	95% CI
Standard Injection Sites (20)	9.73	± 1.12
Reduced Injection Sites (5)	9.67	± 0.99

Change in Neurogenic Bladder Symptoms After BTX-A Treatment - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) Secondary · Baseline and 6-weeks after BTX-A injections

The ICIQ-SF is a standardized survey that assesses the frequency, severity, and impact of urinary incontinence (UI) on quality of life (QoL). The total score, ranging from 0 to 21, is calculated from three questions, with higher scores indicating more severe symptoms. A score of 0 reflects no leakage and no impact on QoL. Question 1 measures how often leakage occurs (0-5), Question 2 assesses the amount of leakage (0-6), and Question 3 evaluates the impact on QoL (0-10), with higher scores indicating worse outcomes. We report the mean difference in total ICIQ and QoL scores from baseline to 6-

Mean difference in Total ICIQ score

Group	Value	95% CI
Standard Injection Sites (20)	-4.11	± 8.25
Reduced Injection Sites (5)	-5.23	± 6.55

Mean difference in ICIQ QoL score

Group	Value	95% CI
Standard Injection Sites (20)	-2.33	± 4.38
Reduced Injection Sites (5)	-3.54	± 3.70

Change in Neurogenic Bladder Symptoms After BTX-A Treatment - Neurogenic Bladder Symptom Score - Short Form (NBSS-SF) Secondary · Baseline and 6-weeks after BTX-A injections

The NBSS-SF is a validated survey with 10 questions that measure bladder symptoms across 3 different domains: incontinence (score range: 0-12), storage and voiding (score range: 0-9), and consequences (score range: 0-7); the highest score is associated with worse symptoms. It also includes one question to assess overall quality of life (QoL) scored from 0 (pleased) to 4 (unhappy). The total score, ranging from 0 to 28, is calculated from the three domains (Q3-Q10), with 0 being the best outcome and 28 the worst outcome. Here we report the mean difference in total NBSS-SF, each of the domains a

Mean difference in Total NBSS-SF

Group	Value	95% CI
Standard Injection Sites (20)	5.44	± 4.19
Reduced Injection Sites (5)	4.65	± 5.46

Mean difference in NBSS-SF QoL

Group	Value	95% CI
Standard Injection Sites (20)	-1.81	± 1.54
Reduced Injection Sites (5)	-2.15	± 1.46

Mean difference in NBSS-SF incontinence domain

Group	Value	95% CI
Standard Injection Sites (20)	-2.93	± 2.92
Reduced Injection Sites (5)	-2.15	± 1.46

Mean difference in NBSS-SF storage and voiding domain

Group	Value	95% CI
Standard Injection Sites (20)	-2.96	± 2.47
Reduced Injection Sites (5)	-3.04	± 3.39

Mean difference in NBSS-SF consequence domain

Group	Value	95% CI
Standard Injection Sites (20)	-2.63	± 2.41
Reduced Injection Sites (5)	-3.00	± 3.19

Patient Impression of Clinical Improvement After BTX-A - Patient Global Impression of Improvement (PGI-I) Scale Secondary · 6 weeks after BTX-A injection

The PGI-I is a validated tool for assessing patient satisfaction after therapy. It consists of a single question using a Likert scale to measure perceived improvement or worsening after BTX-A treatment, ranging from 1 ("Very much worse") to 7 ("Very much better"). Data reported here reflect average scores obtained at the six-week follow-up.

Group	Value	95% CI
Standard Injection Sites (20)	5.26	± 1.04
Reduced Injection Sites (5)	4.88	± 1.09

Patient Reported Procedural Discomfort - Numeric Pain Rating Scale (NPRS) Secondary · Prior to and immediately after BTX-A injections

Participants rated their pain using the NPRS to assess discomfort during the BTX-A procedure. The NPRS is an 11-point scale (0-10), where 0 represents no pain and 10 indicates the worst pain ever experienced. Higher scores reflect greater pain intensity. We report the change in NPRS scores from before to immediately after the procedure.

Group	Value	95% CI
Standard Injection Sites (20)	3.39	± 3.01
Reduced Injection Sites (5)	0.57	± 2.07

Adverse events — posted to ClinicalTrials.gov

Time frame: 6-8 weeks post-injection. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard Injection Sites (20)

Serious: 0/28 (0%)

Deaths: 0/28

Reduced Injection Sites (5)

Serious: 0/26 (0%)

Deaths: 0/26

Other adverse events (7 terms — click to expand)

Reaction	System	Standard Injection Sites (…	Reduced Injection Sites (5)
Urinary Tract Infection (UTI)	Renal and urinary disorders	—	—
Catheter Clogging	Renal and urinary disorders	—	—
New onset gross hematuria	Renal and urinary disorders	—	—
Increased bladder spasms	Renal and urinary disorders	—	—
Decreased cold tolerance	Endocrine disorders	—	—
Hyperglycemia requiring emergency evaluation	Endocrine disorders	—	—
Plasmapheresis for CIDP	Blood and lymphatic system disorders	—	—

Data from ClinicalTrials.gov NCT06059066 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate and standardize the way providers perform OnabotulinumtoxinA (BTX-A) injections into the bladder for the diagnosis of neurogenic lower urinary tract dysfunction (NLUTD)/overactive bladder (OAB). NLUTD/OAB is a syndrome that affects many people, and includes urinary frequency, urinary urgency, urgency incontinence, and nocturia. This syndrome can be challenging to treat and often requires procedural management - including BTX-A injections into the bladder.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Optimizing the Injection Schema for Higher Doses of OnabotulinumtoxinA (BTX-A) in the Office Setting: A Randomized Prospective Trial for Patients With Neurogenic Lower Urinary Tract Dysfunction and Idiopathic Overactive Bladder.
   Chen A, Stewart J, Gonzalez RR, Stampas A, et al · · 2025 · PMID 40836399 · DOI 10.1002/nau.70130