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

NCT06059066 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-05-09

Study results available
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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.

Conditions

  • Neurogenic Bladder
  • Lower Urinary Tract Symptoms
  • Overactive Bladder
  • Neuro: Neurogenic Bladder
  • Neurogenic Detrusor Overactivity

Interventions

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.

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.

Sponsors & Collaborators

  • Collaborating for Advancement of Interdisciplinary Research in Benign Urology

    collaborator UNKNOWN

  • The Methodist Hospital Research Institute

    lead OTHER

Principal Investigators

  • Rose Khavari, MD · Houston Methodist Research Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-04
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06059066 on ClinicalTrials.gov