Bladder Pain Syndrome, Interstitial Cystitis
Conditions
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 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.
Interventions
Bladder instillation instilled via catheter and to dwell for minimum of 30 minutes prior to spontaneous void
Intradetrusor onabotulinumtoxinA injection (0.5mL x 20 sites)
Sponsors
Walter Reed National Military Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in O'Leary-Sant questionnaire scores from baseline between bladder instillation and intradetrusor onabotulinumtoxinA injection groups | Baseline, 8-10 weeks | Consists of O'Leary-Sant Symptom and Problem Index, total score 0-36. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain scores using the Defense and Veterans Pain Rating Scale (visual analog scale) between bladder instillation and intradetrusor onabotulinumtoxinA injection groups | Baseline, 4-6 weeks, 8-10 weeks, 6-9 months | Scale of 0-10 (0= no pain, 10 = worst pain) |
| Change in Female Sexual Function Index (FSFI) score between bladder instillation and intradetrusor onabotulinumtoxinA injection groups | 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. |
| Change in Female Sexual Distress Scale-Revised (FSDS-R) score between bladder instillation and intradetrusor onabotulinumtoxinA injection groups | Baseline, 4-6 weeks, 8-10 weeks | FSDS-R evaluates distress associated with inadequate/impaired sexual function. Total score 0-52. |
| Change in 12-item Short Form Survey (SF-12) score between bladder instillation and intradetrusor onabotulinumtoxinA injection groups | 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. |
| Change in O'Leary-Sant questionnaire scores from baseline between bladder instillation and intradetrusor onabotulinumtoxinA injection groups | Baseline, 4-6 weeks, 6-9 months | Consists of O'Leary-Sant Symptom and Problem Index. Total score 0-36 |
| Incidence of adverse outcomes between bladder instillation and intradetrusor onabotulinumtoxinA injection groups | 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) |
| Patient perceptions of treatment between bladder instillation and intradetrusor onabotulinumtoxinA injection groups | 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). |
| Incidence of re-treatment between bladder instillation and intradetrusor onabotulinumtoxinA injection groups | 6-9 months | Re-treatment defined as additional course or crossover treatment outside of assigned treatment group |
| Change in bladder capacity between bladder instillation and intradetrusor onabotulinumtoxinA injection groups | Baseline, 4-6 weeks, 8-10 weeks | Bladder capacity via 1-day bladder diary |
Countries
United States
Outcome results
None listed