Comparing Number of Injection Sites of In-office Intravesical Onabotulinumtoxin A Treatments for Overactive Bladder: A Randomized Controlled Trial

NCT05157295 | Unknown Phase 4 FDA Drug

• 1 other identifier: 1791493
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Overactive bladder (OAB) is a syndrome characterized by urinary urgency, with or without urinary incontinence, nocturia, and urinary frequency. Intravesical injection of onabotulinumtoxinA is approved by the US Food and Drug Administration for treatment of neurogenic and idiopathic OAB. Current standard of practice involves 100 U of onabotulinumtoxinA diluted in 10 ml saline cystoscopically injected into approximately 20 different detrusor muscle sites equally distributed along the posterior bladder wall and dome. This treatment was classically done in the operating room under general anesthesia, but now is typically performed in an office setting using local anesthesia (lidocaine) as this is more feasible and tolerable. Patients can experience discomfort and pain with each injection. Evidence has also shown that administering the same dose of onabotulinumtoxinA into fewer injection sites in the detrusor muscle (ranging from 3 to 10) results in equivalent efficacy compared to the current standard. However, it has yet to be determined if there is a significant difference in patient satisfaction and tolerability when the procedure is administered in an office setting using the same dosage with fewer injections. Our study aims to assess whether patient tolerance and satisfaction of intravesicular onabotulinumtoxinA increases with the use of 4 detrusor injections as opposed to 20 injections when performed in an office setting on women with OAB.

Conditions

Overactive Bladder Syndrome; Overactive Bladder

Outcome Measures

Primary Outcomes (1)

• Perceived pain of each participant before, during, and after the procedure on a scale of 0-10

  The Pain Survey is a self-reported instrument used to assess pain before, during, and after a procedure. Possible scores range from 0 (no pain) to 10 (worst pain possible).

  within the hour prior to initiating the intervention, and immediately at the conclusion of the 30-minute intervention

Secondary Outcomes (3)

• The Benefit, Satisfaction, and Willingness to Continue of each participant after the procedure

  2 weeks +/- 7 days after procedure and 3 +/- 7 days months after procedure

• Change in extent of Overactive Bladder Symptoms before and after receiving the procedure

  Pre procedure, 2 weeks +/- 7 days after procedure, and 3 +/- 7 days months after procedure

• The Prevalence of complications with botox after receiving the procedure

  2 weeks +/- 7 days after procedure, and 3 +/- 7 days months after procedure

Study Arms (2)

Experimental Group

EXPERIMENTAL

100 U of onabotulinumtoxinA toxin diluted in 10 mL of saline cystoscopically injected into approximately 4 different detrusor muscle sites along the posterior bladder wall and dome.

Drug: OnabotulinumtoxinA

Control Group

ACTIVE COMPARATOR

100 U of onabotulinumtoxinA toxin diluted in 10 mL of saline cystoscopically injected into approximately 20 different detrusor muscle sites along the posterior bladder wall and dome.

Drug: OnabotulinumtoxinA

Interventions

OnabotulinumtoxinA DRUG

100 U of Onabotulinumtoxin A diluted in 10 mL of saline injected into the wall of the detrusor muscle at various sites

Control Group; Experimental Group

Eligibility Criteria

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

You may qualify if:

• females, adults 18 years of age and older, diagnosed with OAB

You may not qualify if:

• bladder pathology including nephrolithiasis, active urinary tract infection, bladder trauma, neurogenic bladder, patients who have previously received intravesical onabotulinumtoxin A injections, pregnant patients, minor patients, male patients

Sponsors & Collaborators

• Augusta University: lead

MeSH Terms

Conditions

Urinary Bladder, Overactive

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

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

• Jennifer Lanzer, MD

  Augusta University

  PRINCIPAL INVESTIGATOR

• Emily Grandprey, DO

  Augusta University

  STUDY DIRECTOR

• Emily Lluch

  Augusta University

  STUDY DIRECTOR

• Ahana Gaurav

  Augusta University

  STUDY DIRECTOR

Central Study Contacts

Stacy Carrigan

CONTACT

7067214959; scarrigan@augusta.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group of participants will receive the "experimental" treatment, which is 4 injections, and the other group of participants will receive the "standard" treatment, which is 20 injections.

Study Record Dates

• First Submitted: November 23, 2021
• First Posted: December 15, 2021
• Study Start: January 1, 2022
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share