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

October 11, 2023 updated by: Walter Reed National Military Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 2

Contacts and Locations

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

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20889
        • Walter Reed National Military Medical Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
Drug: Heparin & Alkalinized Lidocaine Bladder Instillation
Bladder instillation instilled via catheter and to dwell for minimum of 30 minutes prior to spontaneous void
Active Comparator: 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.
Drug: Onabotulinum Toxin A
Intradetrusor onabotulinumtoxinA injection (0.5mL x 20 sites)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in O'Leary-Sant questionnaire scores from baseline between bladder instillation and intradetrusor onabotulinumtoxinA injection groups
Time Frame: Baseline, 8-10 weeks
Consists of O'Leary-Sant Symptom and Problem Index, total score 0-36.
Baseline, 8-10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in O'Leary-Sant questionnaire scores from baseline between bladder instillation and intradetrusor onabotulinumtoxinA injection groups
Time Frame: Baseline, 4-6 weeks, 6-9 months
Consists of O'Leary-Sant Symptom and Problem Index. Total score 0-36
Baseline, 4-6 weeks, 6-9 months
Change in pain scores using the Defense and Veterans Pain Rating Scale (visual analog scale) between bladder instillation and intradetrusor onabotulinumtoxinA injection groups
Time Frame: Baseline, 4-6 weeks, 8-10 weeks, 6-9 months
Scale of 0-10 (0= no pain, 10 = worst pain)
Baseline, 4-6 weeks, 8-10 weeks, 6-9 months
Change in Female Sexual Function Index (FSFI) score between bladder instillation and intradetrusor onabotulinumtoxinA injection groups
Time Frame: Baseline, 4-6 weeks, 8-10 weeks
FSFI evaluates 5 domains of female sexual function including desire, arousal, lubrication, orgasm, satisfaction, and pain. Total score 2-36.
Baseline, 4-6 weeks, 8-10 weeks
Change in Female Sexual Distress Scale-Revised (FSDS-R) score between bladder instillation and intradetrusor onabotulinumtoxinA injection groups
Time Frame: Baseline, 4-6 weeks, 8-10 weeks
FSDS-R evaluates distress associated with inadequate/impaired sexual function. Total score 0-52.
Baseline, 4-6 weeks, 8-10 weeks
Change in 12-item Short Form Survey (SF-12) score between bladder instillation and intradetrusor onabotulinumtoxinA injection groups
Time Frame: Baseline, 4-6 weeks, 8-10 weeks
SF-12 is a general health questionnaire that evaluates quality of life measures, divided into mental and physical component scores.
Baseline, 4-6 weeks, 8-10 weeks
Change in bladder capacity between bladder instillation and intradetrusor onabotulinumtoxinA injection groups
Time Frame: Baseline, 4-6 weeks, 8-10 weeks
Bladder capacity via 1-day bladder diary
Baseline, 4-6 weeks, 8-10 weeks
Incidence of adverse outcomes between bladder instillation and intradetrusor onabotulinumtoxinA injection groups
Time Frame: 8-10 weeks
Adverse outcomes to be defined specific to medication administered (urinary tract infection in both bladder instillation and onabotulinumtoxinA injection groups, urinary retention requiring catheterization, systemic effects related to onabotulinumtoxinA group only)
8-10 weeks
Patient perceptions of treatment between bladder instillation and intradetrusor onabotulinumtoxinA injection groups
Time Frame: 6-9 months
"How convenient or inconvenient was it to follow the treatment schedule as instructed?" (Scale 1-5 extremely inconvenient - extremely convenient) "How satisfied or dissatisfied are you in the ability of the treatment to treat your condition?" (Scale 1-5 extremely dissatisfied - extremely satisfied) "Taking all things into account, how satisfied or dissatisfied are you with this treatment?" (Scale 1-5 extremely dissatisfied - extremely satisfied) "How willing would you be to undergo this treatment again?" (Scale 1-5 extremely unwilling - extremely willing).
6-9 months
Incidence of re-treatment between bladder instillation and intradetrusor onabotulinumtoxinA injection groups
Time Frame: 6-9 months
Re-treatment defined as additional course or crossover treatment outside of assigned treatment group
6-9 months

Collaborators and Investigators

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

Sponsor

Walter Reed National Military Medical Center

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 (Actual)

September 15, 2020

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

May 19, 2020

First Submitted That Met QC Criteria

May 19, 2020

First Posted (Actual)

May 26, 2020

Study Record Updates

Last Update Posted (Actual)

October 12, 2023

Last Update Submitted That Met QC Criteria

October 11, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKW_01-2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

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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