Recruiting

Onabotulinumtoxin A vs. Onabotulinumtoxin A

Sponsor:

University of South Florida

Code:

NCT04305743

Conditions

Urinary Bladder, Overactive

Incontinence, Urge

Incontinence, Urinary

Urinary Urge Incontinence

Urinary Frequency More Than Once at Night

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

OnabotulinumtoxinA 100 UNT

Study Details

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.

Conditions

Urinary Bladder, Overactive

Incontinence, Urge

Incontinence, Urinary

Urinary Urge Incontinence

Urinary Frequency More Than Once at Night

Study ID

NCT04305743

Start date

Oct 9, 2019

Status verified date

Nov, 2020

Completion date

Jun 1, 2021

Anticipated

Primary completion date

Jan 1, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 5 Injections

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.

active comparator: 20 Injections

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.

Interventions

OnabotulinumtoxinA 100 UNT

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

  • Pain from procedure: score [ Time Frame: Within 5 minutes of procedure completion ]

Central Contacts and Locations

Central contacts

Eric S Chang, MD

813-259-8500ericchang@usf.edu

Allison Wyman, MD

813-259-8500awyman@usf.edu

Locations

MedStar Washington Hospital Center

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

Nancy Ringel, MD

nringel@gmail.com

Principal Investigator:

Nancy Ringel, MD

University of South Florida Health South Tampa Center for Advanced Healthcare

Recruiting

Tampa, Florida, United States, 33606

Contacts

Eric S Chang, MD

813-259-8500ericchang@usf.edu

Allison Wyman, MD

813-259-8500awyman@usf.edu

Principal Investigator:

Eric S Chang, MD

More Information

Sponsor

University of South Florida

Last update posted

Nov 5, 2020

Last verified

Nov, 2020

Keywords

  • overactive bladder
  • urgency urinary incontinence
  • onabotulinumtoxin
  • bladder
  • botox

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2020-11-05.