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

NCT04305743 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: PRO00039851
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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; Nocturia

Keywords

overactive bladder; urgency urinary incontinence; onabotulinumtoxin; bladder; botox

Outcome Measures

Primary Outcomes (1)

• Pain from procedure: score

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

  Within 5 minutes of procedure completion

Secondary Outcomes (4)

• Duration of procedure

  Procedure time

• Positive treatment response

  6 weeks post-procedure

• Urinary tract infections

  12 weeks post-procedure

• Urinary retention

  12 weeks post-procedure

Study Arms (2)

5 Injections

EXPERIMENTAL

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.

Drug: OnabotulinumtoxinA 100 UNT

20 Injections

ACTIVE COMPARATOR

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.

Drug: OnabotulinumtoxinA 100 UNT

Interventions

OnabotulinumtoxinA 100 UNT DRUG

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.

Also known as: BOTOX

20 Injections; 5 Injections

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead
• Medstar Health Research Institute: collaborator

Study Sites (2)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

RECRUITING

University of South Florida Health South Tampa Center for Advanced Healthcare

Tampa, Florida, 33606, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 35543540 DERIVED

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge; Urinary Incontinence; Nocturia

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Eric S Chang, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric S Chang, MD

CONTACT

813-259-8500; ericchang@usf.edu

Allison Wyman, MD

CONTACT

813-259-8500; awyman@usf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow Physician

Model Details: Single-blinded randomized controlled trial

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 12, 2020
• Study Start: October 9, 2019
• Primary Completion: January 1, 2021
• Study Completion: June 1, 2021
• Last Updated: November 5, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)