Back to results

Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A

Primary Purpose

Urinary Bladder, Overactive, Incontinence, Urge, Incontinence, Urinary

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

OnabotulinumtoxinA 100 UNT

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring overactive bladder, urgency urinary incontinence, onabotulinumtoxin, bladder, botox

Eligibility Criteria

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

Inclusion Criteria:

Women >=18 years of age with diagnosis of urinary urgency, urinary frequency, urgency urinary incontinence, overactive bladder.
Procedure scheduled in either the outpatient clinic or the operating room to be performed without use of sedation, general, or neuraxial anesthesia.

Exclusion Criteria:

Male gender.
Women <18 years of age.
Non-English speaking.
Pregnancy (patient will self-report pregnancy).
Participant has symptoms of overactive bladder due to any known neurological reason (e.g. spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc.)
Participant uses clean intermittent catheterization or indwelling catheter to manage urinary incontinence.
Participant has a history or current diagnosis of bladder cancer or other urothelial malignancy.
Participant has a known allergy or sensitivity to any botulinum toxin preparation.
Participant has any medical condition that may put her at increased risk with exposure to onabotulinumtoxin A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis.
Participant is scheduled for administration of onabotulinumtoxin A with use of sedation, general, or neuraxial anesthesia.

Sites / Locations

MedStar Washington Hospital CenterRecruiting
University of South Florida Health South Tampa Center for Advanced HealthcareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

5 Injections

20 Injections

Arm Description

Participant's bladder is backfilled with 50 mL of 1% lidocaine for 15 minutes, then drained prior to procedure start. Dose of 100 units onabotulinumtoxin A with dilution to 100 Units/10 mL with preservative-free 0.9% Sodium Chloride Injection is prepared. Cystoscopy is performed. The 23 gauge Laborie InjeTAK needle is inserted 3 mm into the detrusor. 5 injections of 2 mL each (total volume of 10 mL) in a single procedure is performed 1 cm apart in the bladder body. For the final injection, approximately 1 mL of sterile normal saline should be injected such that the remaining onabotulinumtoxin A in the needle is delivered to the bladder.

Participant's bladder is backfilled with 50 mL of 1% lidocaine for 15 minutes, then drained prior to procedure start. Dose of 100 units onabotulinumtoxin A with dilution to 100 Units/10 mL with preservative-free 0.9% Sodium Chloride Injection is prepared. Cystoscopy is performed. The 23 gauge Laborie InjeTAK needle is inserted 3 mm into the detrusor. 20 injections of 0.5 mL each (total volume of 10 mL) in a single procedure is performed 1 cm apart in the bladder body. For the final injection, approximately 1 mL of sterile normal saline should be injected such that the remaining onabotulinumtoxin A in the needle is delivered to the bladder.

Outcomes

Primary Outcome Measures

Pain from procedure: score

Pain score as rated on a 10-point visual analog scale within 5 minutes of procedure completion

Secondary Outcome Measures

Duration of procedure

Total time of procedure defined as time cystoscope is introduced into the bladder to the time the cystoscope is removed from the bladder after completion of all injections

Positive treatment response

The percentage of patients with a positive treatment response based on answering a Global Response Assessment given 6 weeks after completion of procedure

Urinary tract infections

Percentage of patients with culture-proven post-procedure urinary tract infections within 12 weeks of procedure

Urinary retention

Percentage of patients with post-procedure urinary retention requiring clean intermittent catheterization within 12 weeks of procedure

Full Information

NCT ID

NCT04305743

First Posted

March 9, 2020

Last Updated

November 3, 2020

Sponsor

University of South Florida

Collaborators

Medstar Health Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT04305743

Brief Title

Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A

Official Title

Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A for Treatment of Overactive Bladder: a Multi-center Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Recruiting

Study Start Date

October 9, 2019 (Actual)

Primary Completion Date

January 1, 2021 (Anticipated)

Study Completion Date

June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of South Florida

Collaborators

Medstar Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Currently, in clinical practice there has been no standardization in the number of injections a single dose of intradetrusor onabotulinumtoxin A is administered in. Given the increasing use of this treatment modality, the aim of this study is to compare outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to 20 injections for the treatment of overactive bladder or urgency urinary incontinence refractory to medical treatment.

Detailed Description

The intradetrusor injection of onabotulinumtoxin A for treatment of idiopathic overactive bladder and urgency urinary incontinence refractory to anticholinergic or β-agonist treatment was approved by the United States Food and Drug Administration (FDA) in 2013. Since then, multiple randomized placebo-controlled trials have demonstrated the effectiveness of the treatment. Currently, Allergan, Inc. and the FDA recommend the intravesical administration of onabotulinumtoxin A with dilution to 100 units/10 mL with preservative-free 0.9% Sodium Chloride Injection, as 20 injections of 0.5 mL each. Currently, in clinical practice there has been no standardization in the number of intravesical injections, with a single dose of onabotulinumtoxin A being administered in as few as 1 injection to as many as 40 injections into the detrusor muscle. Given the increasing use of this treatment modality, the investigators aim to compare patient outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to the recommended 20 injections for the treatment of idiopathic overactive bladder or urgency urinary incontinence refractory to medical treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Bladder, Overactive, Incontinence, Urge, Incontinence, Urinary, Urinary Urge Incontinence, Urinary Frequency More Than Once at Night, Nocturia

Keywords

overactive bladder, urgency urinary incontinence, onabotulinumtoxin, bladder, botox

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Single-blinded randomized controlled trial

Masking

Participant

Masking Description

Participants are randomized into one of two treatment arms (receiving 5 versus 20 injections per treatment with intradetrusor onabotulinumtoxin A) and are not notified of which arm they are participating in.

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

5 Injections

Arm Type

Experimental

Arm Description

Arm Title

20 Injections

Arm Type

Active Comparator

Arm Description

Participant's bladder is backfilled with 50 mL of 1% lidocaine for 15 minutes, then drained prior to procedure start. Dose of 100 units onabotulinumtoxin A with dilution to 100 Units/10 mL with preservative-free 0.9% Sodium Chloride Injection is prepared. Cystoscopy is performed. The 23 gauge Laborie InjeTAK needle is inserted 3 mm into the detrusor. 20 injections of 0.5 mL each (total volume of 10 mL) in a single procedure is performed 1 cm apart in the bladder body. For the final injection, approximately 1 mL of sterile normal saline should be injected such that the remaining onabotulinumtoxin A in the needle is delivered to the bladder.

Intervention Type

Drug

Intervention Name(s)

OnabotulinumtoxinA 100 UNT

Other Intervention Name(s)

BOTOX

Intervention Description

Intradetrusor onabotulinumtoxin A is administered cystoscopically with 100 unit dose given as either 5 or 20 injections in a single procedure based on the arm the participant is randomized into.

Primary Outcome Measure Information:

Title

Pain from procedure: score

Description

Pain score as rated on a 10-point visual analog scale within 5 minutes of procedure completion

Time Frame

Within 5 minutes of procedure completion

Secondary Outcome Measure Information:

Title

Duration of procedure

Description

Total time of procedure defined as time cystoscope is introduced into the bladder to the time the cystoscope is removed from the bladder after completion of all injections

Time Frame

Procedure time

Title

Positive treatment response

Description

The percentage of patients with a positive treatment response based on answering a Global Response Assessment given 6 weeks after completion of procedure

Time Frame

6 weeks post-procedure

Title

Urinary tract infections

Description

Percentage of patients with culture-proven post-procedure urinary tract infections within 12 weeks of procedure

Time Frame

12 weeks post-procedure

Title

Urinary retention

Description

Percentage of patients with post-procedure urinary retention requiring clean intermittent catheterization within 12 weeks of procedure

Time Frame

12 weeks post-procedure

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women >=18 years of age with diagnosis of urinary urgency, urinary frequency, urgency urinary incontinence, overactive bladder. Procedure scheduled in either the outpatient clinic or the operating room to be performed without use of sedation, general, or neuraxial anesthesia. Exclusion Criteria: Male gender. Women <18 years of age. Non-English speaking. Pregnancy (patient will self-report pregnancy). Participant has symptoms of overactive bladder due to any known neurological reason (e.g. spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc.) Participant uses clean intermittent catheterization or indwelling catheter to manage urinary incontinence. Participant has a history or current diagnosis of bladder cancer or other urothelial malignancy. Participant has a known allergy or sensitivity to any botulinum toxin preparation. Participant has any medical condition that may put her at increased risk with exposure to onabotulinumtoxin A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis. Participant is scheduled for administration of onabotulinumtoxin A with use of sedation, general, or neuraxial anesthesia.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eric S Chang, MD

Phone

813-259-8500

ericchang@usf.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Allison Wyman, MD

Phone

813-259-8500

awyman@usf.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric S Chang, MD

Organizational Affiliation

University of South Florida

Official's Role

Principal Investigator

Facility Information:

Facility Name

MedStar Washington Hospital Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nancy Ringel, MD

nringel@gmail.com

First Name & Middle Initial & Last Name & Degree

Amy Park, MD

First Name & Middle Initial & Last Name & Degree

Cheryl Iglesia, MD

First Name & Middle Initial & Last Name & Degree

Nancy Ringel, MD

Facility Name

University of South Florida Health South Tampa Center for Advanced Healthcare

City

Tampa

State/Province

Florida

ZIP/Postal Code

33606

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eric S Chang, MD

Phone

813-259-8500

ericchang@usf.edu

First Name & Middle Initial & Last Name & Degree

Allison Wyman, MD

Phone

813-259-8500

awyman@usf.edu

First Name & Middle Initial & Last Name & Degree

Isabel Prieto, MD

First Name & Middle Initial & Last Name & Degree

Ryan Hidalgo, MD

First Name & Middle Initial & Last Name & Degree

Renee Bassaly, DO

First Name & Middle Initial & Last Name & Degree

Kristie Greene, MD

First Name & Middle Initial & Last Name & Degree

Allison Wyman, MD

First Name & Middle Initial & Last Name & Degree

Eric S Chang, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

All statistical analyses will be performed at the University of South Florida. The investigators performing review of data and statistical analyses will not require the use of, or have access to any personally identifying patient information from either the primary or secondary site of the study.

Citations:

PubMed Identifier

35543540

Citation

Chang ES, Ringel N, Woodburn KL, Tanner JP, Bassaly R, Greene K, Wyman A, Iglesia C. Postprocedural Pain Associated With 5 Versus 20 Intradetrusor Injections of onabotulinumtoxinA for Treatment of Overactive Bladder: A Multicenter Randomized Clinical Trial. Urogynecology (Phila). 2022 Aug 1;28(8):518-525. doi: 10.1097/SPV.0000000000001199. Epub 2022 May 12.

Results Reference

derived

Learn more about this trial

Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A

We'll reach out to this number within 24 hrs