Optimal Injection Interval for Intra-Detrusor Botulinum Toxin

July 15, 2024 updated by: Zachary S Selzler, MD, Louisiana State University Health Sciences Center in New Orleans

Optimal Injection Interval for Intra-Detrusor Botulinum Toxin: A Randomized Controlled Trial Utilizing a Patient-Centered Approach

The goal of this clinical trial is to see if patients deciding their own follow up times can increase the effectiveness of botulinum toxin (BTX or "Botox") injection for overactive bladder (OAB). The main questions it aims to answer are:

  • Does the time between repeat injections differ from the 6-month standard when it is based on patient symptoms alone?
  • Does symptom control or patient satisfaction change when patients control their own follow up times?

Participants will undergo standard botulinum toxin injection into the bladder for OAB treatment and will then be randomly assigned to follow up either at a standard 6-month interval or whenever they feel their symptoms return.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Overactive bladder (OAB) is defined by symptoms of urinary urgency, frequency, or nocturia with or without incontinence in the absence of urinary tract infection or other attributable pathology. This disease affects up to 40% of women in the United States and can have a significant impact on quality of life. It is expected to increase in prevalence with the aging US population. There are a wide variety of treatment options for OAB which range from fluid management and lifestyle modifications (first line therapy), pelvic floor physical therapy and oral medications (second line therapy), and procedural interventions such as neuromodulation or intravesical botulinum toxin (BTX-A) injections (third line therapy).

BTX-A is a potent neurotoxin derived from the anaerobic bacterium Clostridium botulinum that inhibits presynaptic release of acetylcholine from motor neurons at the neuromuscular junction to induce flaccid paralysis of musculature. It has also been found to affect sensory responses of nerve afferent nerve fibers and likely has a complex multifactorial effect on the release of excitatory neurotransmitters. Because of this, injection of BTX-A into the detrusor muscle of the bladder has become a highly effective treatment option for OAB, first approved by the FDA in January 2013. Prior studies have demonstrated superior efficacy of intravesical BTX-A injections compared to anticholinergic medication and a greater reduction in urge urinary incontinence episodes than sacral neuromodulation.

The effect of intravesical BTX-A is temporary due to turnover of presynaptic molecules. Typical chemodenervation of muscular tissue lasts 3 to 6 months based on histologic evidence, however this does not translate directly to duration of OAB symptom control given the gradual nature of neurotransmitter repletion. The largest prior trial of intravesical BTX-A demonstrated a median interval of 350 days between first and second injection, but other studies have shown a wide range of duration from 5 to 15 months. The current FDA recommendation for repeat injection is to be "considered when the clinical effect from the previous injection has diminished" with a median interval in their double-blinded placebo-controlled studies of 169 days.

Despite this recommendation, there is a wide variety in practice patterns for repeat injections, including the use of a "one size fits all" approach with standardized repeat injections at 6-month intervals. Combined with varying rates of tolerability and treatment failure, this has resulted in inconsistent data on continuation and dropout rates for repeat injections, with reported continuation rates of 20-60% in different studies. Additionally, no prior studies have reported whether repeat injection intervals have been provider- or patient-determined, nor with data on patient satisfaction ratings. Further studies are needed to better delineate optimal injection interval as well as incorporate data on what methods lead to the highest patient satisfaction and symptom control.

The purpose of this study is to ascertain the optimal time interval to repeat injection will be when it is purely patient directed based on symptomatology. Investigators will also evaluate patient satisfaction with this approach compared to standardized repeat injection interval of six months. This has the potential to change the way OAB is managed by allowing patients to control the interval to repeat injection in a safe and controlled manner. Investigators hypothesize that a patient-centered approach to repeating BTX-A injections will be similar to the standard FDA 6-month interval while leading to higher patient satisfaction and continuation rates without compromising safety or efficacy.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University Health Science Center
        • Contact:
        • Sub-Investigator:
          • Zachary Selzler, MD
        • Principal Investigator:
          • Lisa Peacock, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • diagnosis of overactive bladder, detrusor overactivity, urinary urgency, urinary frequency, nocturnal polyuria, or urge urinary incontinence
  • pursuing treatment with intravesical botulinum toxin injections

Exclusion Criteria:

- non-OAB diagnosis such as pelvic pain or interstitial cystitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of care
Standard 6 month post-operative follow up interval for repeat injection
Experimental: Patient-directed follow up
Post-operative follow up interval for repeat injection decided by patient based on OAB symptomatology (3-12 months)
Behavioral: Patient-directed follow up
Patients will be instructed to follow up for repeat injection based on bladder symptomatology at their own self-determined time interval.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Injection interval
Time Frame: Days from initial injection to repeat injection, up to 365 days
time to repeat injection (days)
Days from initial injection to repeat injection, up to 365 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction
Time Frame: 1-2 weeks post-injection
Scores from the Surgical Satisfaction Questionnaire (SSQ-8), which contains 8 questions on satisfaction with a likert scale rating of 1-5. Higher scores indicate higher patient satisfaction.
1-2 weeks post-injection
Symptom Control
Time Frame: baseline scores immediately pre-injection, post-treatment scores 1-2 weeks post-injection
Scores from the Overactive Bladder Assessment Tool (OAB-Q), which contains 5 questions on symptoms and 5 questions on quality of life with a likert scale rating of 0-5. Higher scores on the symptom section indicate WORSE overactive bladder symptoms and higher scores on the quality of life section indicate higher levels of bother/WORSE quality of life.
baseline scores immediately pre-injection, post-treatment scores 1-2 weeks post-injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Investigators

  • Principal Investigator: Lisa Peacock, MD, Louisiana State University Health Science Center - New Orleans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

June 25, 2024

First Submitted That Met QC Criteria

June 28, 2024

First Posted (Actual)

July 3, 2024

Study Record Updates

Last Update Posted (Actual)

July 17, 2024

Last Update Submitted That Met QC Criteria

July 15, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #7564

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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