Procedural Discomfort Related to Number of Intradetrusor Botox Injections

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Overactive Bladder

Intervention / Treatment
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* Biological: Intradetrusor Botox Injections


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 5 mL Group<br>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<br>* 100 units of OnabotuliumtoxinA is injected into the detrusor muscle in 1 mL aliquots using a cystoscope.<br>|
| Active Comparator: 10 mL Group<br>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<br>* 100 units of OnabotuliumtoxinA is injected into the detrusor muscle in 1 mL aliquots using a cystoscope.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient discomfort related to BTX-A injection | We will assess the difference in the Numeric Rating Scale (NRS) scores related to bladder discomfort prior to and during the BTX-A procedure. The NRS scale is an 11 point scale (0-10) with higher numbers indicating higher pain scores. | Immediately post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural Efficacy | Efficacy will be evaluated using the Overactive Bladder Symptom and Health-Related Quality of Life Short-Form (OAB-q SF) validated questionnaire. The OAB-q SF is a condition-specific questionnaire developed to assess the symptom bother and health related quality of life (HRQL) impact of OAB in the last 4 weeks. Patients will fill this out on the day of the procedure and then again at 30-days post-procedure and the total scores will be compared. | Prior to the procedure and at 30 days post-procedure | 
| 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 | 
| Impression of clinical improvement | Patients impression of clinical improvement after treatmentment 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive bladder, Urinary urgency, Urgency incontinence, Botox