← Back to Search

Procedure

BTX-A Injection Techniques for Overactive Bladder (BOND Trial)

N/A
Recruiting
Led By Rose Khavari, MD
Research Sponsored by The Methodist Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of neurogenic bladder indicated for treatment with BTX-A for OAB symptoms.
Be older than 18 years old
Must not have
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.
Women who are currently pregnant or breast feeding.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately after injection, 6 week follow-up after btx-a injection
Awards & highlights

Summary

This trial will evaluate how best to use BTX-A injections to treat NLUTD/OAB, a syndrome that affects many people and is challenging to treat.

Who is the study for?
This trial is for adults over 18 with neurogenic bladder due to conditions like MS, Parkinson's, stroke, or spinal injuries. They must need BTX-A injections for overactive bladder symptoms and be able to consent and follow the study plan. Pregnant women, those breastfeeding, with UTI symptoms or untreated bladder cancer can't join.
What is being tested?
The study aims to find the best way to give OnabotulinumtoxinA (BTX-A) injections in patients with neurogenic lower urinary tract dysfunction. It compares a reduced number of injection sites against the standard practice in managing overactive bladder symptoms.
What are the potential side effects?
Possible side effects include discomfort at injection sites, potential urinary retention requiring catheterization, urinary tract infections from the procedure itself, and general weakness which are common risks associated with BTX-A.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a bladder condition needing Botox for overactive symptoms.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a UTI with symptoms like pain, blood in urine, or needing to urinate often.
Select...
I am not currently pregnant or breastfeeding.
Select...
I cannot have Botox injections into my bladder.
Select...
I have been diagnosed with a chronic pain syndrome such as fibromyalgia or pelvic pain.
Select...
I have bladder cancer that has not been treated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately after injection, 6 week follow-up after btx-a injection
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately after injection, 6 week follow-up after btx-a injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Willingness to repeat procedure visual analog scale
Secondary study objectives
ICIQ-UI SF Questionnaire
NBSS-SF
Numeric Pain Rating Scale
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Reduced Injection SitesExperimental Treatment1 Intervention
Reduced number of injections
Group II: Standard Injection SitesActive Control1 Intervention
Standard number of injections

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor
281 Previous Clinical Trials
81,528 Total Patients Enrolled
3 Trials studying Lower Urinary Tract Symptoms
51 Patients Enrolled for Lower Urinary Tract Symptoms
Collaborating for the Advancement of Interdisciplinary Research in Benign UrologyUNKNOWN
Rose Khavari, MDPrincipal InvestigatorHouston Methodist Research Group
9 Previous Clinical Trials
448 Total Patients Enrolled
3 Trials studying Lower Urinary Tract Symptoms
51 Patients Enrolled for Lower Urinary Tract Symptoms
~0 spots leftby Oct 2024
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top