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NCT Number: NCT04401176

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.

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Key information

Conditions

Interstitial Cystitis Bladder Pain Syndrome Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heparin & Alkalinized Lidocaine Bladder Instillation

Drug

Bladder instillation instilled via catheter and to dwell for minimum of 30 minutes prior to spontaneous void

Onabotulinum toxin A

Drug

Intradetrusor onabotulinumtoxinA injection (0.5mL x 20 sites)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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)

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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. 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).

  9. 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

Sponsors and collaborators

Lead sponsor

Walter Reed National Military Medical Center

Fed

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 26, 2020
Registry last updated
Oct 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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