Neurogenic BladderBONDNCT06059066
Optimization of OnabotulinumtoxinA (BTX-A) Injection for the Treatment of Neurogenic Lower Urinary Tract Dysfunction
A study testing Standard number of injection sites and Reduced number of injection sites in people with Neurogenic Bladder and Lower Urinary Tract Symptoms, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurogenic Bladder, Lower Urinary Tract Symptoms, Overactive Bladder
- What is being tested?
- Standard number of injection sites and Reduced number of injection sites
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women (>18 years of age) with a diagnosis of neurological conditions such as MS, PD, CVA, myelomeningocele, SCI, or traumatic brain injury longer than 6 months prior to treatment.
- Diagnosis of neurogenic bladder indicated for treatment with BTX-A for OAB symptoms.
- Participants must be able to provide informed consent, as well as understand and be willing to undergo.
- follow-up procedures and completion of all questionnaires provided during the study.
Who cannot join
- Symptomatic UTI at the time of procedure, defined as positive nitrites or high-volume leukocyte esterase on urine dip in addition to at least one of the following symptoms: dysuria, gross hematuria, suprapubic pain, frequency/urgency above baseline.
- Diagnosis of bladder pain syndrome or other chronic pain syndrome including fibromyalgia, chronic pelvic pain, pelvic floor dysfunction, levator myalgia.
- Untreated bladder malignancy.
- Women who are currently pregnant or breast feeding.
- Contraindications to intradetrusor BTX-A injections.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Neurological disorders such as Multiple Sclerosis (MS), Spinal Cord Injury (SCI), Parkinson's Disease (PD), Spina Bifida (SB), and stroke disrupt neural control of voiding and lead to the development of neurogenic lower urinary tract dysfunction (NLUTD), which develops when either the detrusor muscle fails to maintain effective contractions (voiding phase) or fails to relax appropriately with low pressures (storage phase), if the urethral sphincter (internal or external) fails to lower its tonicity and resistance, or if there is an asynchrony in events eventually leading to detrusor sphincter dyssynergia (DSD). Different patterns of NLUTD (including both storage and voiding) can arise depending on the level of injury or type of neurological disease. It can be characterized by urinary urgency, frequency and incontinence or urinary hesitancy and retention that leads to urinary tract infections (UTIs). Some patients develop neurogenic overactive bladder (NOAB).
Management of NOAB symptoms is complex. Treatment with BTX-A has been shown to decrease episodes of urinary incontinence and improve quality of life in this population. It has also been shown to ameliorate a multitude of devastating complications, such as upper tract deterioration, recurrent urinary tract infections, sepsis, and death. According to the current manufacturer's recommendation, a standard 200-unit vial of Botox® should be diluted in 30cc of 0.9% saline and injected across 30 different sites in the detrusor muscle (Figure 2). Despite these guidelines, there are wide variations in administration techniques, raising the question what is the best depth and location for injection, and optimal concentration and volume of toxin per injection site. The objective of this study is to determine the optimal injection schema for 200 units or more of intradetrusor BTX-A in patients with NOAB in the office setting.
The investigators hypothesize that patients with NOAB symptoms undergoing intradetrusor injection of 200 units (or more) of BTX-A will be more willing to pursue additional sessions of BTX-A injections with a protocol utilizing less injection sites, while still maintaining effectiveness of the procedure.
- Conditions
- Neurogenic Bladder, Lower Urinary Tract Symptoms, Overactive Bladder, Neuro: Neurogenic Bladder, Neurogenic Detrusor Overactivity
- Being tested
- Standard number of injection sites, Reduced number of injection sites
- Keywords
- neurogenic bladder, Lower urinary tract symptoms, Neurogenic detrusor overactivity, Onabotulinum toxinA
- Medical subject headings
- Urinary Bladder, Neurogenic, Lower Urinary Tract Symptoms, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard number of injection sitesProcedure or surgery
200 units or 300 units BTX-A reconstituted in 20 mL normal saline, injected into the bladder detrusor in 20 separate injections of 1 mL including the trigone.
Reduced number of injection sitesProcedure or surgery
200 units or 300 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder detrusor in 5 separate injections of 1 mL including the trigone.
| Study group | Role | What they receive |
|---|---|---|
| Standard Injection Sites | Active comparator | Standard number of injections Receives: Procedure: Standard number of injection sites |
| Reduced Injection Sites | Experimental | Reduced number of injections Receives: Procedure: Reduced number of injection sites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Willingness to Repeat 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.
Measured: Immediately post-procedure and 6 weeks post-procedure
Secondary outcomes (4)
Change in Neurogenic Bladder Symptoms After BTX-A Treatment - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
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-weeks post-treatment.
Measured: Baseline and 6-weeks after BTX-A injections
Change in Neurogenic Bladder Symptoms After BTX-A Treatment - Neurogenic Bladder Symptom Score - Short Form (NBSS-SF)
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 and QoL scores from baseline to 6-weeks post-treatment.
The NBSS-SF is a validated 10-question survey that assesses bladder symptoms across three domains: incontinence (score range: 0-12), storage and voiding (score range: 0-9), and consequences (score range: 0-7), with higher scores indicating worse symptoms. It also includes a quality of life (QoL) question (Q2) scored from 0 (pleased)
Measured: Baseline and 6-weeks after BTX-A injections
Patient Impression of Clinical Improvement After BTX-A - Patient Global Impression of Improvement (PGI-I) Scale
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.
Measured: 6 weeks after BTX-A injection
Patient Reported Procedural Discomfort - Numeric Pain Rating Scale (NPRS)
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.
Measured: Prior to and immediately after BTX-A injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start4 Oct 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurogenic BladderStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Collaborating for Advancement of Interdisciplinary Research in Benign Urology
- Responsible party
- Sponsor
- Investigators
- Rose Khavari, MD, Principal investigator, Houston Methodist Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06059066
- Sponsor's protocol ID
- PRO00037721
- Acronym
- BOND
- Status last verified
- Mar 2025
- First submitted
- 22 Sep 2023
- Last updated
- 9 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen A, Stewart J, Gonzalez RR, Stampas A, Kobashi K, Khavari R. 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. Neurourol Urodyn. 2025 Nov;44(8):1537-1544. doi: 10.1002/nau.70130. Epub 2025 Aug 20.
PubMed 40836399
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of OnabotulinumtoxinA (BTX-A) Injection for the Treatment of Neurogenic Lower Urinary Tract Dysfunction
- ClinicalTrials.gov ID
- NCT06059066
- Acronym / sponsor ID
- BOND / PRO00037721
- Conditions
- Neurogenic Bladder, Lower Urinary Tract Symptoms, Overactive Bladder, Neuro: Neurogenic Bladder, Neurogenic Detrusor Overactivity
- Keywords
- neurogenic bladder, Lower urinary tract symptoms, Neurogenic detrusor overactivity, Onabotulinum toxinA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Collaborating for Advancement of Interdisciplinary Research in Benign Urology
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 28 Sep 2023 (actual)
- Results
- Posted 9 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Neurological disorders such as Multiple Sclerosis (MS), Spinal Cord Injury (SCI), Parkinson's Disease (PD), Spina Bifida (SB), and stroke disrupt neural control of voiding and lead to the development of neurogenic lower urinary tract dysfunction (NLUTD), which develops when either the detrusor muscle fails to maintain effective contractions (voiding phase) or fails to relax appropriately with low pressures (storage phase), if the urethral sphincter (internal or external) fails to lower its tonicity and resistance, or if there is an asynchrony in events eventually leading to detrusor sphincter dyssynergia (DSD). Different patterns of NLUTD (including both storage and voiding) can arise depending on the level of injury or type of neurological disease. It can be characterized by urinary urgency, frequency and incontinence or urinary hesitancy and retention that leads to urinary tract infections (UTIs). Some patients develop neurogenic overactive bladder (NOAB).
Management of NOAB symptoms is complex. Treatment with BTX-A has been shown to decrease episodes of urinary incontinence and improve quality of life in this population. It has also been shown to ameliorate a multitude of devastating complications, such as upper tract deterioration, recurrent urinary tract infections, sepsis, and death. According to the current manufacturer's recommendation, a standard 200-unit vial of Botox® should be diluted in 30cc of 0.9% saline and injected across 30 different sites in the detrusor muscle (Figure 2). Despite these guidelines, there are wide variations in administration techniques, raising the question what is the best depth and location for injection, and optimal concentration and volume of toxin per injection site. The objective of this study is to determine the optimal injection schema for 200 units or more of intradetrusor BTX-A in patients with NOAB in the office setting.
The investigators hypothesize that patients with NOAB symptoms undergoing intradetrusor injection of 200 units (or more) of BTX-A will be more willing to pursue additional sessions of BTX-A injections with a protocol utilizing less injection sites, while still maintaining effectiveness of the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Injection Sites | Active comparator | Procedure: Standard number of injection sitesStandard number of injections |
| Reduced Injection Sites | Experimental | Procedure: Reduced number of injection sitesReduced number of injections |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult men and women (>18 years of age) with a diagnosis of neurological conditions such as MS, PD, CVA, myelomeningocele, SCI, or traumatic brain injury longer than 6 months prior to treatment.
- Diagnosis of neurogenic bladder indicated for treatment with BTX-A for OAB symptoms.
- Participants must be able to provide informed consent, as well as understand and be willing to undergo.
- follow-up procedures and completion of all questionnaires provided during the study.
Key exclusion criteria (5 listed)
- Symptomatic UTI at the time of procedure, defined as positive nitrites or high-volume leukocyte esterase on urine dip in addition to at least one of the following symptoms: dysuria, gross hematuria, suprapubic pain, frequency/urgency above baseline.
- Diagnosis of bladder pain syndrome or other chronic pain syndrome including fibromyalgia, chronic pelvic pain, pelvic floor dysfunction, levator myalgia.
- Untreated bladder malignancy.
- Women who are currently pregnant or breast feeding.
- Contraindications to intradetrusor BTX-A injections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard number of injection sites200 units or 300 units BTX-A reconstituted in 20 mL normal saline, injected into the bladder detrusor in 20 separate injections of 1 mL including the trigone. | Procedure or surgery | Standard Injection Sites |
| Reduced number of injection sites200 units or 300 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder detrusor in 5 separate injections of 1 mL including the trigone. | Procedure or surgery | Reduced Injection Sites |
Primary outcome
Willingness to Repeat Procedure
Time frame: 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.
4 secondary outcomes
Change in Neurogenic Bladder Symptoms After BTX-A Treatment - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Time frame: Baseline and 6-weeks after BTX-A injections
Change in Neurogenic Bladder Symptoms After BTX-A Treatment - Neurogenic Bladder Symptom Score - Short Form (NBSS-SF)
Time frame: Baseline and 6-weeks after BTX-A injections
Patient Impression of Clinical Improvement After BTX-A - Patient Global Impression of Improvement (PGI-I) Scale
Time frame: 6 weeks after BTX-A injection
Patient Reported Procedural Discomfort - Numeric Pain Rating Scale (NPRS)
Time frame: Prior to and immediately after BTX-A injections
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40836399Chen A, Stewart J, Gonzalez RR, Stampas A, Kobashi K, Khavari R. 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. Neurourol Urodyn. 2025 Nov;44(8):1537-1544. doi: 10.1002/nau.70130. Epub 2025 Aug 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rose Khavari, MD principal investigator
Houston Methodist Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard number of injection sites and Reduced number of injection sites in people with Neurogenic Bladder and Lower Urinary Tract Symptoms, run by The Methodist Hospital Research Institute 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 9 May 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Willingness to Repeat Procedure (time frame: Immediately post-procedure and 6 weeks post-procedure). 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 NCT06059066, which also lists 1 linked publication.
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 May 2025.