Procedural Discomfort Related to Number of Intradetrusor Botox Injections

Overactive Bladder Clinical Trial

— BIND  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05652036
• Other study ID #: PRO00028592
• Status: Recruiting
• Phase: Phase 4
• Start date: July 7, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: December 2022
• Source: The Methodist Hospital Research Institute
• Contact: Lia Miceli, MD
• Phone: 724-809-0046
• Email: lmamiceli[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 131
• Est. completion date: July 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Biological:
• Intradetrusor Botox Injections
100 units of OnabotuliumtoxinA is injected into the detrusor muscle in 1 mL aliquots using a cystoscope.

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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