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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

BOND Trial 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.Check my eligibility

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.See study design

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.

BOND Trial 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.

BOND Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately prior to injection, immediately after btx-a injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately prior to injection, immediately after btx-a injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately prior to injection, immediately after btx-a injection for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Willingness to repeat procedure visual analog scale

Secondary outcome measures

ICIQ-UI SF Questionnaire

NBSS-SF

Numeric Pain Rating Scale

+1 more

BOND 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Methodist Hospital Research InstituteLead Sponsor

274 Previous Clinical Trials

80,457 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies remaining in this clinical trial?

"Confirmed. According to the information collected on clinicaltrials.gov, this medical study is now actively looking for participants with an initial post date of October 4th 2023 and a last update made on October 20th 2023. The trial needs 78 patients from 1 site in order to move forward."

Answered by AI

How many study participants have been enrolled in the ongoing clinical trial?

"Affirmative. According to clinicaltrials.gov, the posted trial is still recruiting and was initially announced on October 4th 2023 before being last modified October 20th of this same year. 78 patients are required from one medical site for participation in this research effort."

Answered by AI