Procedural Discomfort Related to Number of Intradetrusor Botox Injections (BIND)

Procedural Discomfort Related to Number of Intradetrusor Injections of OnabotulinumtoxinA for Idiopathic Overactive Bladder: A Randomized Control Trial of an Alternate Reconstitution Volume and Injection Template Protocol

Injection of intradetrusor OnabotulinumtoxinA (BTX-A) is a highly efficacious therapy with a reliable safety profile and demonstrable improvements in subjective and objective measures for overactive bladder (OAB) symptom control. This procedure can be performed in the office with an evidence-based standard dosing of 100 units for idiopathic OAB. This is a single-blinded, randomized control trial is to evaluate and optimize the technique for performing intradetrusor injections of BTX-A for idiopathic OAB. This trial proposes two different reconstitution and injection schema to study patient-centered outcomes related to procedural discomfort and symptom relief.

Study Overview

• Status: Completed
• Conditions: Overactive Bladder
• Intervention / Treatment: Biological: Intradetrusor Botox Injections

Detailed Description

This will be a single-blinded, parallel randomized control trial (RCT) utilizing two study arms. This trial will be designed and reported as outlined in the CONSORT guidelines

The primary aim of this study is to evaluate perceived discomfort using the Numeric Pain Scale (NPS) during office injection of intradetrusor BTX-A via two different injection techniques and reconstitution volumes.

The secondary aims of this study are to evaluate treatment effectiveness and patient satisfaction of treatment with BTX-A using validated questionnaires. Investigators will also compare procedure time and post-procedure complication rates between the two study groups.

Study Groups: The patients will be randomized in a 1:1 fashion to one of two groups:

• 100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone
• 100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone

The primary outcome will be measured on the day of the procedure using the NPS scale. Investigators will follow up with patients at 30 days post-procedure to assess treatment effectiveness, overall satisfaction, and post-procedure outcomes using validated questionnaires.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women scheduled to undergo 100 units intradetrusor BTX-A injections in the office for the diagnosis of idiopathic overactive bladder within the departments of Urology and Urogynecology
• 18 years of age or older
• Able to give informed consent in English or Spanish
• Understand and are willing to undergo follow-up and complete all questionnaires as described in this protocol

Exclusion Criteria:

• Neurogenic bladder related to prior diagnosis of neurological conditions such as cerebral vascular accident within 6 months prior to treatment, Parkinson's Disease, Multiple Sclerosis, myelomeningocele, traumatic neurologic or spinal injury, or idiopathic diagnosis of neurogenic bladder.
• 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 a bladder pain syndrome or other chronic pain syndromes including fibromyalgia, chronic pelvic pain, pelvic floor dysfunction, levator myalgia
• Known bladder malignancy
• Previous history of bladder augmentation or reconstructive surgery not related to prolapse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 5 mL Group; 100 units BTX-A reconstituted in 5 mL normal saline, injected into the bladder in 5 separate injections of 1 mL. One injection will be at the trigone.	Biological: Intradetrusor Botox Injections; 100 units of OnabotuliumtoxinA is injected into the detrusor muscle in 1 mL aliquots using a cystoscope.
Active Comparator: 10 mL Group; 100 units BTX-A reconstituted in 10 mL normal saline, injected into the bladder in 10 separate injections of 1 mL. One injection will be at the trigone	Biological: Intradetrusor Botox Injections; 100 units of OnabotuliumtoxinA is injected into the detrusor muscle in 1 mL aliquots using a cystoscope.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant Discomfort Related to BTX-A Injection	Participants will assess their discomfort using the Numeric Pain Scale (NPS), a validated 11-point scale (0-10) where higher scores indicate greater pain, before and immediately after the procedure. Procedural discomfort will be evaluated by comparing the change in NPS scores from pre- to post-procedure between study groups.	Immediately post-procedure (up to 45min after intradetrusor BTX-A injections)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Treatment Satisfaction	Overall treatment satisfaction will be assessed at 30-days post-procedure via a "yes or no" response to inquiry about overall satisfaction with the procedure and results of their BTX-A treatment	30 days post-procedure
Procedural Efficacy - Overactive Bladder Questionnaire Short-Form (OAB-q SF)	Efficacy will be evaluated using the Overactive Bladder Questionnaire Short-Form (OAB-q SF), a validated instrument designed to measure symptom bother (SB) and the impact of OAB on health-related quality of life (HRQL). This questionnaire is administered on the day of the procedure (baseline) and again 30 days post-procedure. Changes in SB and HRQL scores assess improvement in OAB symptoms following BTX-A treatment. The OAB-q SF includes 19 items divided into two subscales: a 6-item SB scale (Questions 1-6) and a 13-item HRQL scale (Questions 7-19). SB items are scored from 1 ("not at all") to 6 ("a very great deal"), yielding a total SB score range of 6 to 36, with higher scores indicating greater symptom bother. HRQL items are scored from 1 ("none of the time") to 6 ("all of the time"), with total scores ranging from 13 to 78, where higher scores reflect better quality of life. We report here the mean change in SB and HRQL scores from baseline to 30 days post-treatment.	Prior to BTX-A injections and 30 days post-procedure
Impression of Clinical Improvement	Patients impression of clinical improvement after treatment will be assessed at 30-day post-procedure via the Clinical Global Impression - Improvement Scale (CGI-I). The CGI-I is a seven point verbal scale with higher values indicating higher impression of symptomatic improvement related to the treatment. Scale reports values as: Very much improved, Much improved, Minimally improved, No difference.	30 days post-procedure
Procedural Outcomes	We will review the electronic medical record to evaluate instances of symptomatic urinary tract infection, bothersome incomplete bladder emptying requiring catheterization, and instances of bleeding requiring evaluation after the procedure.	30 days post-procedure

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute
• Investigators: Principal Investigator: Rose Khavari, MD, The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Actual): April 6, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: March 28, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Botox; Overactive bladder; Urinary urgency; Urgency incontinence
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Urinary Bladder, Overactive
• Other Study ID Numbers: PRO00028592

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes