Bladder Instillations Versus Onabotulinumtoxin A for Treatment of Interstitial Cystitis/Bladder Pain Syndrome

Walter Reed National Military Medical Center

Status and phase: Completed; Phase 2

Conditions: Interstitial Cystitis; Bladder Pain Syndrome

Treatments: Drug: Onabotulinum Toxin A; Drug: Heparin & Alkalinized Lidocaine Bladder Instillation

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04401176

EKW_01-2020

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Females ≥ 18 years of age
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

58 participants in 2 patient groups

Heparin & Alkalinized Lidocaine Bladder Instillation

Active Comparator group

Description:

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).

Treatment:

Drug: Heparin & Alkalinized Lidocaine Bladder Instillation

Intradetrusor Onabotulinumtoxin A Injection

Active Comparator group

Description:

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.

Treatment:

Drug: Onabotulinum Toxin A