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

Sponsor

The Methodist Hospital Research Institute (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06059066

Collaborator

Collaborating for the Advancement of Interdisciplinary Research in Benign Urology (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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). 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.

Condition or Disease	Intervention/Treatment	Phase
Neurogenic Bladder Lower Urinary Tract Symptoms Overactive Bladder Neuro: Neurogenic Bladder Neurogenic Detrusor Overactivity	Procedure: Standard number of injection sites Procedure: Reduced number of injection sites	N/A

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.

We 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

Study Type:

Interventional

Anticipated Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Injection Sites Standard number of injections	Procedure: 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.
Experimental: Reduced Injection Sites Reduced number of injections	Procedure: 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.

Arm

Intervention/Treatment

Active Comparator: Standard Injection Sites

Standard number of injections

Procedure: 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.

Experimental: Reduced Injection Sites

Reduced number of injections

Procedure: 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.

Outcome Measures

Primary Outcome Measures

Willingness to repeat procedure scale [Immediately after injection, 6 week follow-up after BTX-A injection]
A likert scale to measure the patient's willingness to repeat procedure

Secondary Outcome Measures

ICIQ-UI SF Questionnaire [Immediately prior to injection, 6 week follow-up after BTX-A injection]
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form standardized survey to measure change in neurogenic bladder symptoms before and after BTX-A
NBSS-SF [Immediately prior to injection, 6 week follow-up after BTX-A injection]
Neurogenic bladder symptom score-short form standardized survey to measure change in neurogenic bladder symptoms before and after BTX-A
PGI score [Immediately after injection, 6 week follow-up after BTX-A injection]
Patient global impression of improvement after adminstration of BTX-A
Numeric Pain Rating Scale [Immediately prior to injection, immediately after BTX-A injection]
Patient's rating of pain before and after BTX-A treatment

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.