Procedural Discomfort Related to Number of Intradetrusor Botox Injections

Phase 4

Recruiting

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
10 mL Group	Intradetrusor Botox Injections	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
5 mL Group	Intradetrusor Botox Injections	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.

Primary Outcome Measures

Name	Time	Method
Patient discomfort related to BTX-A injection	Immediately post-procedure	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.

Secondary Outcome Measures

Name	Time	Method
Procedural outcomes	30 days post-procedure	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.
Procedural Efficacy	Prior to the procedure and at 30 days post-procedure	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.
Overall Treatment Satisfaction	30 days post-procedure	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
Impression of clinical improvement	30 days post-procedure	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.