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

No Placebo-Only Group

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

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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:

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I have a UTI with symptoms like pain, blood in urine, or needing to urinate often.

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I am not currently pregnant or breastfeeding.

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I cannot have Botox injections into my bladder.

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I have been diagnosed with a chronic pain syndrome such as fibromyalgia or pelvic pain.

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I have bladder cancer that has not been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately after injection, 6 week follow-up after btx-a injection

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.