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| Name | Class |
|---|---|
| Collaborating for Advancement of Interdisciplinary Research in Benign Urology | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Injection Sites | Active Comparator | Standard number of injections |
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| Reduced Injection Sites | Experimental | Reduced number of injections |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard number of injection sites | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediately post-procedure and 6 weeks post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
follow-up procedures and completion of all questionnaires provided during the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rose Khavari, MD | Houston Methodist Research Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40836399 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Injection Sites | Standard number of injections Standard number of injection sites: 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. |
| FG001 | Reduced Injection Sites |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 10, 2024 |
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| Reduced number of injection sites | Procedure | 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. |
|
| 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) | 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. | 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. | Prior to and immediately after BTX-A injections |
Reduced number of injections Reduced number of injection sites: 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. |
| COMPLETED |
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| NOT COMPLETED |
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Initially, 78 patients met the inclusion criteria and provided consent. Two were later excluded: one due to urinary tract infection symptoms and a suspicious urinalysis, and the other due to severe autonomic dysreflexia, which was identified after consent but before the procedure. The physician deemed the procedure unsafe in the clinic setting, leading to exclusion.
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Injection Sites (20) | Standard number of injection sites: 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. |
| BG001 | Reduced Injection Sites (5) | Reduced number of injection sites: 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Medical comorbidities | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data at 6-weeks post-procedure were available for 54 participants. Loss to follow-up included 10 participants from the 20-injection group and 12 participants from the 5-injection group. | Posted | Mean | Standard Deviation | units on a scale | Immediately post-procedure and 6 weeks post-procedure |
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| Secondary | 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. | Data at 6-weeks post-procedure were available for 54 participants. Loss to follow-up included 10 participants from the 20-injection group and 12 participants from the 5-injection group. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6-weeks after BTX-A injections |
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| Secondary | 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) | Data at 6-weeks post-procedure were available for 54 participants. Loss to follow-up included 10 participants from the 20-injection group and 12 participants from the 5-injection group. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 6-weeks after BTX-A injections |
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| Secondary | 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. | Data at 6-weeks post-procedure were available for 54 participants. Loss to follow-up included 10 participants from the 20-injection group and 12 participants from the 5-injection group. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks after BTX-A injection |
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| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Prior to and immediately after BTX-A injections |
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6-8 weeks post-injection
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Injection Sites (20) | Standard number of injections (20 injections): 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. | 0 | 28 | 0 | 28 | 7 | 28 |
| EG001 | Reduced Injection Sites (5) | Reduced number of injections (5 injections): 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. | 0 | 26 | 0 | 26 | 8 | 26 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection (UTI) | Renal and urinary disorders | Systematic Assessment |
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| Catheter Clogging | Renal and urinary disorders | Systematic Assessment |
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| New onset gross hematuria | Renal and urinary disorders | Systematic Assessment |
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| Increased bladder spasms | Renal and urinary disorders | Systematic Assessment |
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| Decreased cold tolerance | Endocrine disorders | Systematic Assessment |
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| Hyperglycemia requiring emergency evaluation | Endocrine disorders | Systematic Assessment |
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| Plasmapheresis for CIDP | Blood and lymphatic system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julu Benoy | Houston Methodist Hospital | (713) 441-6455 | jbenoy@houstonmethodist.org |
| Mar 5, 2025 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 10, 2024 | Mar 5, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D001750 | Urinary Bladder, Neurogenic |
| D059411 | Lower Urinary Tract Symptoms |
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020924 | Urological Manifestations |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Sacral Agenesis |
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| Spina Bifida |
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| Spinal Cord Injury |
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| Cerebral Vascular Accident |
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| Parkinsons Disease |
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| Chronic Inflammatory Demyelinating Polyneuropathy |
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| Syringomyelia |
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| Transverse Myelitis |
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| 6-weeks post-procedure willingness to repeat procedure rating (VAS score) |
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| t-test, 2 sided |
| 0.83 |
Threshold for statistical significance used P-value <0.05 |
| Other |
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| Reduced Injection Sites (5) |
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. |
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| Participants |
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