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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heparin & Alkalinized Lidocaine Bladder Instillation | Active Comparator | 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). |
|
| Intradetrusor Onabotulinumtoxin A Injection | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin & Alkalinized Lidocaine Bladder Instillation | Drug | Bladder instillation instilled via catheter and to dwell for minimum of 30 minutes prior to spontaneous void |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in O'Leary-Sant questionnaire scores from baseline between bladder instillation and intradetrusor onabotulinumtoxinA injection groups | Consists of O'Leary-Sant Symptom and Problem Index, total score 0-36. | Baseline, 8-10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in O'Leary-Sant questionnaire scores from baseline between bladder instillation and intradetrusor onabotulinumtoxinA injection groups | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19260081 | Background | Hanno P, Dmochowski R. Status of international consensus on interstitial cystitis/bladder pain syndrome/painful bladder syndrome: 2008 snapshot. Neurourol Urodyn. 2009;28(4):274-86. doi: 10.1002/nau.20687. | |
| 21683389 | Background | Berry SH, Elliott MN, Suttorp M, Bogart LM, Stoto MA, Eggers P, Nyberg L, Clemens JQ. Prevalence of symptoms of bladder pain syndrome/interstitial cystitis among adult females in the United States. J Urol. 2011 Aug;186(2):540-4. doi: 10.1016/j.juro.2011.03.132. Epub 2011 Jun 16. |
| Label | URL |
|---|---|
| American Urological Association Interstitial Cystitis Guidelines | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 23, 2020 | May 19, 2022 |
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| Onabotulinum Toxin A | Drug | Intradetrusor onabotulinumtoxinA injection (0.5mL x 20 sites) |
|
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 | 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 | 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 | 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 | 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 | 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 | "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 | Re-treatment defined as additional course or crossover treatment outside of assigned treatment group | 6-9 months |
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| 38768800 | Derived | Welch EK, Dengler KL, DiCarlo-Meacham AM, Wheat JE, Pekny CJ, Aden JK, Vaccaro CM. Bladder instillations vs onabotulinumtoxinA injection for interstitial cystitis/bladder pain syndrome: a randomized clinical trial. Am J Obstet Gynecol. 2024 Nov;231(5):528.e1-528.e11. doi: 10.1016/j.ajog.2024.05.027. Epub 2024 May 18. |
| ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 13, 2026 | Apr 30, 2026 | 6 |
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| C000629279 | onabotulinum toxin A |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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