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Is 10 Injections of Bladder Botox Less Painful Than 20 Injections?

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
OnabotulinumtoxinA 100 Units
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Overactive Bladder, Botox/OnabotulinumtoxinA, Pain, OAB, Non-neurogenic Overactive bladder

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 1. Female gender
  • 2. At least 18 years of age
  • 3. Have already decided to undergo intradetrusor Botox® injections for treatment of refractory overactive bladder.
  • 4. Able and willing to learn clean intermittent catheterization (or care provider is willing and able to perform intermittent catheterization).
  • 5. Understands and is willing to undergo follow up and complete questionnaires as described in this protocol
  • 6. Able to give informed consent

Exclusion Criteria:

  • 1. Male gender
  • 2. Neurological conditions (Examples: Cerebral vascular accident within 6 months prior to treatment, Parkinson's disease, Multiple Sclerosis, and Spina Bifida).
  • 3. Acute urinary tract infection
  • 4. Treatment with Botox® toxin for other conditions
  • 5. Allergy to Botox® toxin
  • 6. Hematuria that has not been worked up
  • 7. Known bladder malignancy
  • 8. Previous history of bladder augmentation
  • 9. Currently pregnant (with no plans to become pregnant within 6 months of enrollment) or breastfeeding
  • 10. Currently taking aminoglycoside antibiotics
  • 11. PVR >150 cc (measured by bladder scan or by catheterization) prior to enrollment
  • 12. History of chronic pain or pain syndromes

Sites / Locations

  • Urology clinic locations at Wake Forest Baptist Medical Center
  • Urology clinic locations at Wake Forest Baptist Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

10 Botox Injections

20 Botox Injections

Arm Description

100 units of Botox® (onabotulinumtoxinA) will be combined with 10 cc of sterile saline for the purpose of 10 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone.

100 units of Botox® (onabotulinumtoxinA) will be combined with 20 cc of sterile saline for the purpose of 20 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone.

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale (NPRS)
The patients will rate their level of pain from 0 as no pain to 10 as a severe pain immediately following the completion of bladder injections by selecting a whole number from 0 to 10 that represents their level of pain during the procedure.

Secondary Outcome Measures

Difference in Mean Urge Incontinence Episodes
The mean urge incontinence episodes which will be calculated by averaging the amount of urge urinary incontinence episodes over 3 days as recorded in a bladder diary at week 12 after the procedure
Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms
Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life
Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms
Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life
Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms
Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life
Over Active Bladder (OAB) Questionnaire Short Form Scores - Health Related Quality of Life
Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO.
Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life
Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO.
Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life
Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO.
Post-Void Residual (PVR)
PVR using bladder scanner evaluates the post void residual in the bladder.
Post-Void Residual (PVR)
PVR using bladder scanner evaluates the post void residual in the bladder.

Full Information

First Posted
October 10, 2019
Last Updated
October 11, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04124939
Brief Title
Is 10 Injections of Bladder Botox Less Painful Than 20 Injections?
Official Title
A Randomized Clinical Trial of 100 Units of Intradetrusor Onabotulinum Toxin A for Refractory Overactive Bladder - Is 10 Injections Less Painful Than 20 Injections?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
November 10, 2019 (Actual)
Primary Completion Date
November 9, 2022 (Actual)
Study Completion Date
February 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

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.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this research study is to help determine if 10 injections of Botox ® 100 units is less painful than 20 injections of Botox ® 100 units based on effectiveness in reducing urge incontinence episodes. Study will also be assessed for the pain of procedure and adverse outcomes of 20 injections versus 10 injections.
Detailed Description
This study is a randomized clinical trial to assess whether or not 10 injections of 100 units of intradetrusor Botox® toxin is perceived as less painful compared to 20 injections of 100 units of intradetrusor Botox® toxin for the treatment of refractory overactive bladder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder
Keywords
Overactive Bladder, Botox/OnabotulinumtoxinA, Pain, OAB, Non-neurogenic Overactive bladder

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
10 Botox Injections
Arm Type
Active Comparator
Arm Description
100 units of Botox® (onabotulinumtoxinA) will be combined with 10 cc of sterile saline for the purpose of 10 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone.
Arm Title
20 Botox Injections
Arm Type
Active Comparator
Arm Description
100 units of Botox® (onabotulinumtoxinA) will be combined with 20 cc of sterile saline for the purpose of 20 injections. The bladder will be instilled with 2% lidocaine solution through a catheter for at least 5 minutes prior to the procedure. Cystoscopy with either a rigid or flexible cystoscope (per surgeon preference) will be performed using sterile technique. The Botox® will be injected in a grid like pattern avoiding the trigone.
Intervention Type
Drug
Intervention Name(s)
OnabotulinumtoxinA 100 Units
Other Intervention Name(s)
BOTOX
Intervention Description
BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for: • Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
The patients will rate their level of pain from 0 as no pain to 10 as a severe pain immediately following the completion of bladder injections by selecting a whole number from 0 to 10 that represents their level of pain during the procedure.
Time Frame
Post Procedure Day 1
Secondary Outcome Measure Information:
Title
Difference in Mean Urge Incontinence Episodes
Description
The mean urge incontinence episodes which will be calculated by averaging the amount of urge urinary incontinence episodes over 3 days as recorded in a bladder diary at week 12 after the procedure
Time Frame
Week 12 after procedure
Title
Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms
Description
Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life
Time Frame
Baseline
Title
Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms
Description
Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life
Time Frame
2 weeks post procedure
Title
Over Active Bladder (OAB) Questionnaire Short Form Scores - Symptoms
Description
Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 0 - to 100-point scale, with lower scores indicating greater effect, i.e., worse Quality of Life
Time Frame
12 weeks post procedure
Title
Over Active Bladder (OAB) Questionnaire Short Form Scores - Health Related Quality of Life
Description
Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO.
Time Frame
Baseline
Title
Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life
Description
Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO.
Time Frame
2 weeks post procedure
Title
Over Active Bladder (OAB) Questionnaire Short Form - Health Related Quality of Life
Description
Secondary endpoints to be assessed as OAB symptoms using Overactive Bladder Questionnaire Short Form (OABq-SF) at baseline, 2 weeks and 12 week post-procedure. 13 items to assess health Related Quality of Life (HRQOL). Total range 0 to 100. A higher score on the HRQOL scale indicates a better HRQO.
Time Frame
12 weeks post procedure
Title
Post-Void Residual (PVR)
Description
PVR using bladder scanner evaluates the post void residual in the bladder.
Time Frame
2 weeks post procedure
Title
Post-Void Residual (PVR)
Description
PVR using bladder scanner evaluates the post void residual in the bladder.
Time Frame
12 weeks post procedure

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female gender At least 18 years of age Have already decided to undergo intradetrusor Botox® injections for treatment of refractory overactive bladder. Able and willing to learn clean intermittent catheterization (or care provider is willing and able to perform intermittent catheterization). Understands and is willing to undergo follow up and complete questionnaires as described in this protocol Able to give informed consent Exclusion Criteria: Male gender Neurological conditions (Examples: Cerebral vascular accident within 6 months prior to treatment, Parkinson's disease, Multiple Sclerosis, and Spina Bifida). Acute urinary tract infection Treatment with Botox® toxin for other conditions Allergy to Botox® toxin Hematuria that has not been worked up Known bladder malignancy Previous history of bladder augmentation Currently pregnant (with no plans to become pregnant within 6 months of enrollment) or breastfeeding Currently taking aminoglycoside antibiotics Post-void residual (PVR) >150 cc (measured by bladder scan or by catheterization) prior to enrollment History of chronic pain or pain syndromes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Matthews, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology clinic locations at Wake Forest Baptist Medical Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27455
Country
United States
Facility Name
Urology clinic locations at Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Is 10 Injections of Bladder Botox Less Painful Than 20 Injections?

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