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

NCT06059066 | Completed Results DMC

• 1 other identifier: PRO00037721
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Willingness to Repeat Procedure

  Participants were asked to rate their willingness to repeat the procedure using an 11-point visual analog scale (VAS). A score of 0 ("Never") indicates complete unwillingness, representing the least favorable outcome, while a score of 11 ("Definitely") reflects strong willingness, representing the most favorable outcome.

  Immediately post-procedure and 6 weeks post-procedure

Secondary Outcomes (4)

• Change in Neurogenic Bladder Symptoms After BTX-A Treatment - International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)

  Baseline and 6-weeks after BTX-A injections

• Change in Neurogenic Bladder Symptoms After BTX-A Treatment - Neurogenic Bladder Symptom Score - Short Form (NBSS-SF)

  Baseline and 6-weeks after BTX-A injections

• Patient Impression of Clinical Improvement After BTX-A - Patient Global Impression of Improvement (PGI-I) Scale

  6 weeks after BTX-A injection

• Patient Reported Procedural Discomfort - Numeric Pain Rating Scale (NPRS)

  Prior to and immediately after BTX-A injections

Study Arms (2)

Standard Injection Sites

ACTIVE COMPARATOR

Standard number of injections

Procedure: Standard number of injection sites

Reduced Injection Sites

EXPERIMENTAL

Reduced number of injections

Procedure: Reduced number of injection sites

Interventions

Standard number of injection sites PROCEDURE

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.

Standard Injection Sites

Reduced number of injection sites PROCEDURE

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.

Reduced Injection Sites

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead
• Collaborating for Advancement of Interdisciplinary Research in Benign Urology: collaborator

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Chen A, Stewart J, Gonzalez RR, Stampas A, Kobashi K, Khavari R. Optimizing the Injection Schema for Higher Doses of OnabotulinumtoxinA (BTX-A) in the Office Setting: A Randomized Prospective Trial for Patients With Neurogenic Lower Urinary Tract Dysfunction and Idiopathic Overactive Bladder. Neurourol Urodyn. 2025 Nov;44(8):1537-1544. doi: 10.1002/nau.70130. Epub 2025 Aug 20.

  PMID: 40836399 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Lower Urinary Tract Symptoms; Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urological Manifestations

Results Point of Contact

• Title: Julu Benoy
• Organization: Houston Methodist Hospital

jbenoy@houstonmethodist.org

(713) 441-6455

Study Officials

• Rose Khavari, MD

  Houston Methodist Research Group

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2023
• First Posted: September 28, 2023
• Study Start: October 4, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)