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

Primary Purpose

Overactive Bladder

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Intradetrusor Botox Injections
Sponsored by
The Methodist Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive bladder, Urinary urgency, Urgency incontinence, Botox

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Houston Methodist HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

5 mL Group

10 mL Group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.
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.

Full Information

First Posted
December 7, 2022
Last Updated
December 14, 2022
Sponsor
The Methodist Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05652036
Brief Title
Procedural Discomfort Related to Number of Intradetrusor Botox Injections
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Methodist Hospital Research Institute

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Overactive bladder, Urinary urgency, Urgency incontinence, Botox

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
131 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5 mL Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
10 mL Group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Intradetrusor Botox Injections
Intervention Description
100 units of OnabotuliumtoxinA is injected into the detrusor muscle in 1 mL aliquots using a cystoscope.
Primary Outcome Measure Information:
Title
Patient discomfort related to BTX-A injection
Description
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.
Time Frame
Immediately post-procedure
Secondary Outcome Measure Information:
Title
Procedural Efficacy
Description
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.
Time Frame
Prior to the procedure and at 30 days post-procedure
Title
Overall Treatment Satisfaction
Description
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
Time Frame
30 days post-procedure
Title
Impression of clinical improvement
Description
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.
Time Frame
30 days post-procedure
Title
Procedural outcomes
Description
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.
Time Frame
30 days post-procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lia Miceli, MD
Phone
724-809-0046
Email
lmamiceli@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hamida Rajab
Phone
713-363-9154
Email
hrajab@houstonmethodist.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rose Khavari, MD
Organizational Affiliation
The Methodist Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lia Miceli, MD
Phone
724-809-0046
Email
lmmiceli@houstonmethodist.org
First Name & Middle Initial & Last Name & Degree
Lia M Miceli, MD
First Name & Middle Initial & Last Name & Degree
Julie M Stewart, MD
First Name & Middle Initial & Last Name & Degree
Daniele D Antosh, MD
First Name & Middle Initial & Last Name & Degree
Katheryn Williams, MD
First Name & Middle Initial & Last Name & Degree
Emily Rutledge, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Procedural Discomfort Related to Number of Intradetrusor Botox Injections

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