Status:
COMPLETED
Bladder Instillations Versus Onabotulinumtoxin A for Treatment of Interstitial Cystitis/Bladder Pain Syndrome
Lead Sponsor:
Walter Reed National Military Medical Center
Conditions:
Interstitial Cystitis
Bladder Pain Syndrome
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 physi...
Eligibility Criteria
Inclusion
- Females ≥ 18 years of age
- O'Leary-Sant questionnaire score ≥ 6
- Ability to follow study instructions and complete all required follow-up
Exclusion
- 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
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT04401176
Start Date
September 15 2020
End Date
June 1 2023
Last Update
October 12 2023
Active Locations (1)
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1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889