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

Primary Purpose

Neurogenic Bladder, Lower Urinary Tract Symptoms, Overactive Bladder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard number of injection sites
Reduced number of injection sites
Sponsored by
The Methodist Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurogenic Bladder focused on measuring neurogenic bladder, Lower urinary tract symptoms, Neurogenic detrusor overactivity, Onabotulinum toxinA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Houston Methodist HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Injection Sites

Reduced Injection Sites

Arm Description

Standard number of injections

Reduced number of injections

Outcomes

Primary Outcome Measures

Willingness to repeat procedure visual analog scale
A likert scale to measure the patient's willingness to repeat procedure. 0=Never (worst outcome), 7=Definitely (best outcome)

Secondary Outcome Measures

ICIQ-UI SF Questionnaire
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form standardized survey to measure change in neurogenic bladder symptoms before and after BTX-A. 12=Worst, 0=Best.
NBSS-SF
Neurogenic bladder symptom score-short form standardized survey to measure change in neurogenic bladder symptoms before and after BTX-A. 21=worst score possible, 0=best score possible
PGI score
Patient global impression of improvement after adminstration of BTX-A. 1=Very much worse, 7=Very much better
Numeric Pain Rating Scale
Patient's rating of pain before and after BTX-A treatment. 0=no pain (best), 10=worst pain of my life (worst outcome)

Full Information

First Posted
September 22, 2023
Last Updated
October 20, 2023
Sponsor
The Methodist Hospital Research Institute
Collaborators
Collaborating for the Advancement of Interdisciplinary Research in Benign Urology
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1. Study Identification

Unique Protocol Identification Number
NCT06059066
Brief Title
Optimization of OnabotulinumtoxinA (BTX-A) Injection for the Treatment of Neurogenic Lower Urinary Tract Dysfunction
Acronym
BOND
Official Title
Optimization of OnabotulinumtoxinA (BTX-A) Injection for the Treatment of Neurogenic Lower Urinary Tract Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2023 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Methodist Hospital Research Institute
Collaborators
Collaborating for the Advancement of Interdisciplinary Research in Benign Urology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
78 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Injection Sites
Arm Type
Active Comparator
Arm Description
Standard number of injections
Arm Title
Reduced Injection Sites
Arm Type
Experimental
Arm Description
Reduced number of injections
Intervention Type
Procedure
Intervention Name(s)
Standard number of injection sites
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Reduced number of injection sites
Intervention Description
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.
Primary Outcome Measure Information:
Title
Willingness to repeat procedure visual analog scale
Description
A likert scale to measure the patient's willingness to repeat procedure. 0=Never (worst outcome), 7=Definitely (best outcome)
Time Frame
Immediately after injection, 6 week follow-up after BTX-A injection
Secondary Outcome Measure Information:
Title
ICIQ-UI SF Questionnaire
Description
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form standardized survey to measure change in neurogenic bladder symptoms before and after BTX-A. 12=Worst, 0=Best.
Time Frame
Immediately prior to injection, 6 week follow-up after BTX-A injection
Title
NBSS-SF
Description
Neurogenic bladder symptom score-short form standardized survey to measure change in neurogenic bladder symptoms before and after BTX-A. 21=worst score possible, 0=best score possible
Time Frame
Immediately prior to injection, 6 week follow-up after BTX-A injection
Title
PGI score
Description
Patient global impression of improvement after adminstration of BTX-A. 1=Very much worse, 7=Very much better
Time Frame
Immediately after injection, 6 week follow-up after BTX-A injection
Title
Numeric Pain Rating Scale
Description
Patient's rating of pain before and after BTX-A treatment. 0=no pain (best), 10=worst pain of my life (worst outcome)
Time Frame
Immediately prior to injection, immediately after BTX-A injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annie Chen, MD
Phone
(713) 441-6455
Email
achen@houstonmethodist.org
First Name & Middle Initial & Last Name or Official Title & Degree
Hamida Rajab
Phone
(713) 441-6455
Email
hrajab@houstonmethodist.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rose Khavari, MD
Organizational Affiliation
Houston Methodist Research Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamida Rajab
Phone
713-441-6455
Email
hrajab@houstonmethodist.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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