Bladder Instillations Versus Onabotulinumtoxin A for Treatment of Interstitial Cystitis/Bladder Pain Syndrome
NCT ID: NCT04401176
Last Updated: 2023-10-12
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2
Total Enrollment
58 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-09-15
Study Completion Date
2023-06-01
Brief Summary
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Recognition of interstitial cystitis (IC)/bladder pain syndrome (BPS) is increasing. There is a dire need to develop effective treatment options for these patients as it manifests as more than a physical disease, affecting general and psychological health as well. Existing trials comparing varying bladder instillation formulations have not identified an optimal bladder instillation therapy, however existing studies support combined heparin and alkalinized lidocaine bladder instillation as an affordable and effective treatment for IC/BPS. Additionally, intradetrusor onabotulinumtoxinA injection has been well established for the treatment of overactive bladder (OAB), a constellation of symptoms similar to that of IC/BPS. OnabotulinumtoxinA has now come into the forefront for treatment of OAB due to its efficacy, safety profile, and absence of cognitive effects related to the previous mainstay anticholinergic treatment. While both bladder instillation and onabotulinumtoxinA therapy have been shown to be effective for treatment of IC/BPS, a direct comparison of these treatments has not been performed. We therefore designed a randomized controlled trial to compare the efficacy of heparin with alkalized local anesthetic bladder instillation versus intradetrusor onabotulinumtoxinA injection in treating IC/BPS symptoms.
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Detailed Description
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Conditions
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Interstitial Cystitis
Bladder Pain Syndrome
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Heparin & Alkalinized Lidocaine Bladder Instillation
Six weekly bladder instillations, each instillation consisting of 40,000 IU Heparin, 200mg lidocaine, 2ml 8.4% sodium bicarbonate, sterile water for a total volume 50 milliliters (mL).
Group Type
ACTIVE_COMPARATOR
Heparin & Alkalinized Lidocaine Bladder Instillation
Intervention Type
DRUG
Bladder instillation instilled via catheter and to dwell for minimum of 30 minutes prior to spontaneous void
Intradetrusor Onabotulinumtoxin A Injection
100 units onabotulinumtoxinA reconstituted in 10mL of injectable saline, injected in 20 sites with 0.5mL per injection along the posterior wall of the bladder above the trigone.
Group Type
ACTIVE_COMPARATOR
Onabotulinum Toxin A
Intervention Type
DRUG
Intradetrusor onabotulinumtoxinA injection (0.5mL x 20 sites)
Interventions
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Heparin & Alkalinized Lidocaine Bladder Instillation
Bladder instillation instilled via catheter and to dwell for minimum of 30 minutes prior to spontaneous void
Intervention Type
DRUG
Onabotulinum Toxin A
Intradetrusor onabotulinumtoxinA injection (0.5mL x 20 sites)
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Females ≥ 18 years of age
* O'Leary-Sant questionnaire score ≥ 6
* Ability to follow study instructions and complete all required follow-up
* O'Leary-Sant questionnaire score ≥ 6
* Ability to follow study instructions and complete all required follow-up
Exclusion Criteria
* Contraindications and/or allergies to medications used
* Known alternative diagnosis explaining bladder pain symptoms
* Bladder instillation within the past 3 months
* Intradetrusor onabotulinumtoxinA injection within the past 6 months
* Use of ≥ 400 units of onabotulinumtoxinA in the last 3 months
* Inability or unwillingness to self-catheterize
* Post-void residual \> 200mL
* Concurrent procedural treatment (including hydrodistension, sacral neuromodulation)
* Current use of vaginal pessary/devices
* Untreated symptomatic prolapse \> pelvic organ prolapse quantification system (POP-Q) stage 2
* Females who are pregnant or planning a pregnancy during the study or who think that they may be pregnant at the start of the study and who are unwilling or unable to use a reliable form of contraception during the study
* Inability to speak/read English
* Known alternative diagnosis explaining bladder pain symptoms
* Bladder instillation within the past 3 months
* Intradetrusor onabotulinumtoxinA injection within the past 6 months
* Use of ≥ 400 units of onabotulinumtoxinA in the last 3 months
* Inability or unwillingness to self-catheterize
* Post-void residual \> 200mL
* Concurrent procedural treatment (including hydrodistension, sacral neuromodulation)
* Current use of vaginal pessary/devices
* Untreated symptomatic prolapse \> pelvic organ prolapse quantification system (POP-Q) stage 2
* Females who are pregnant or planning a pregnancy during the study or who think that they may be pregnant at the start of the study and who are unwilling or unable to use a reliable form of contraception during the study
* Inability to speak/read English
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Walter Reed National Military Medical Center
FED
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Walter Reed National Military Medical Center
Bethesda, Maryland, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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https://www.auanet.org/guidelines/interstitial-cystitis-(ic/bps)-guideline
American Urological Association Interstitial Cystitis Guidelines
Other Identifiers
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EKW_01-2020
Identifier Type: -
Identifier Source: org_study_id
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