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Interstitial cystitis/bladder pain syndrome (IC/BPS) is a condition that results in long-term bladder and pelvic pain. IC/BPS affects women more often than men. How the disorder develops is not completely known. Bladder instillation is a commonly used treatment in which a mixture of different ingredients are passed into the bladder to help IC/BPS symptoms. There is room to learn more about bladder instillations and which ingredients in them work best. The purpose of this study is to compare the effectiveness of a bladder instillation that contains a steroid (triamcinolone acetonide) to a bladder instillation that does not contain a steroid to treat IC/BPS in women. The study hypothesis is that women with IC/BPS treated with bladder instillations that contain a steroid will have improved outcomes compared to women treated with bladder instillations that do not contain a steroid.
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a chronic pain disorder involving the genitourinary tract. IC/BPS disproportionately affects women with over 80% of patients with IC/BPS as female. Like other chronic pain conditions, IC/BPS is physically and emotionally taxing on patients. IC/BPS costs the United States over $100 million annually due to direct healthcare costs and loss of worker productivity. The exact pathophysiology of the disease is unknown, leading to a limitation in our ability to treat the disorder effectively. The current leading etiologic theory is that IC/BPS is a neurologically-derived chronic systemic pain syndrome due to its association with musculoskeletal pelvic pain, irritable bowel syndrome, chronic fatigue syndrome, fibromyalgia, and vulvodynia. Although several options exist to treat IC/BPS, therapeutic effects are often transient. Previous studies in chronic pain disorders have shown that multimodal treatment is more effective than single-agent treatment, so future therapy should aim to augment rather than replace current treatments. Bladder instillation is a commonly used treatment in which a mixture of different agents is instilled into the bladder to improve IC/BPS symptoms. The data on the efficacy of bladder instillations, as well as which ingredients in the mixture are effective, are limited. Small studies have shown the potential of steroids in decreasing IC/BPS; the mechanism of action is hypothesized to be due to decrease inflammation in the bladders of these patients. The knowledge gap that exists is the necessity of a steroid in the bladder instillation treatment for IC/BPS symptoms especially since this tends to be the most expensive ingredient.
To evaluate the utility of a steroid in the bladder instillation treatment of IC/BPS, we propose a randomized, double-blind, controlled trial that will compare the efficacy of bladder instillations with and without triamcinolone acetonide on IC/BPS symptoms in women. We hypothesize that the addition of triamcinolone acetonide in bladder instillation therapy will result in a more robust treatment response than bladder instillations without triamcinolone acetonide. Our rationale is based on 1) the results of small studies that showed improvement of IC/BPS symptoms with use of a steroid and 2) the hypothesized mechanism of action of steroids decreasing inflammation in the bladder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bladder instillation WITH triamcinolone acetonide | Active Comparator | Six weekly bladder instillations of standard cocktail plus triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL). |
|
| Bladder instillation WITHOUT triamcinolone acetonide | Placebo Comparator | Six weekly bladder instillations of standard cocktail without triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bladder instillation WITH triamcinolone acetonide | Drug | Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL). |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire | Total scores range: 0-36 (0= no symptoms to 36= the most severe symptoms) | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported |
| Measure | Description | Time Frame |
|---|---|---|
| Pelvic Pain and Urgency/Frequency (PUF) Questionnaire | Total scores range: 0-35 (0= no symptoms to 35= the most severe symptoms) | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported |
| Overactive Bladder Questionnaire (OAB-q) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivia Cardenas-Trowers, M.D. | University of Louisville | Principal Investigator |
| Sean Francis, M.D. | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville Urogynecology at Springs Medical Center | Louisville | Kentucky | 40205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15592041 | Background | Clemens JQ, Meenan RT, Rosetti MC, Gao SY, Calhoun EA. Prevalence and incidence of interstitial cystitis in a managed care population. J Urol. 2005 Jan;173(1):98-102; discussion 102. doi: 10.1097/01.ju.0000146114.53828.82. | |
| 15049588 | Background | Nickel JC. Interstitial cystitis: a chronic pelvic pain syndrome. Med Clin North Am. 2004 Mar;88(2):467-81, xii. doi: 10.1016/S0025-7125(03)00151-2. |
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De-identified raw data and other supporting materials will be made available to approved investigators. Email requests to olivia.cardenas-trowers@louisville.edu.
Data will be available beginning 1 month and ending 24 months following article publication.
Available to investigators whose proposed use of the data is for individual participant data meta-analysis and has been approved by an independent review committee for this purpose. To gain access, data requestors will need to sign a data access agreement.
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Participants were women with IC/BPS who were recruited from January 2019 to October 2020 from the University of Louisville Female Pelvic Medicine & Reconstructive Surgery clinic in Louisville, KY.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bladder Instillation WITH Triamcinolone Acetonide | Six weekly bladder instillations WITH triamcinolone acetonide: mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 mg)/1 mL. |
| FG001 | Bladder Instillation WITHOUT Triamcinolone Acetonide | Six weekly bladder instillations WITHOUT triamcinolone acetonide: mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bladder Instillation WITH Triamcinolone Acetonide | Six weekly bladder instillations WITH triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 mg/1 mL). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire | Total scores range: 0-36 (0= no symptoms to 36= the most severe symptoms) | Posted | Mean | Standard Deviation | scores on a scale | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported |
|
Through study completion, an average of 6 weeks.
The risk for these severe events is low because the risk of the intervention is known to be low.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bladder Instillation WITH Triamcinolone Acetonide | Six weekly bladder instillations of standard cocktail plus triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL). Bladder instillation WITH triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urethral pain | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sean Francis | University of Louisville | 502-561-7260 | Sean.francis@louisville.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 23, 2019 | Jun 25, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000283 | Administration, Intravesical |
| D014222 | Triamcinolone Acetonide |
| ID | Term |
|---|---|
| D000287 | Administration, Topical |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| Bladder instillation WITHOUT triamcinolone acetonide | Drug | Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL). |
|
Total scores range: 0-100 (higher scores on the symptom-severity scale suggestive of greater severity of symptoms and higher scores on the quality-of-life scale suggestive of better quality of life)
| Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported |
| Pelvic Floor Distress Inventory (PFDI) | 20 question self-administered questionnaire on the presence and absence of pelvic floor symptoms. Score ranges from 0 (least distress) to 300 (most distress). | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported |
| Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire | Measures sexual function in women with pelvic floor disorders. Queries about arousal, orgasm, partner-related issues, sexual quality, and desire. The tool also takes into account those who are not sexually active. The questionnaire was used in the study solely to determine if patients had improved dyspareunia (as a categorical variable). | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported |
| Change From Baseline in Treatment Response as Measured by the Visual Analogue Scale (VAS) for Pain | VAS is measured on marking on a 10-centimeter (cm) ruler (measured in cm, 0= no pain and 10= most severe pain possible) | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported |
| Number of Participants With at Least One Adverse Event | Adverse events will only be those determined to be related to the study drug | End of study (6 weeks) |
| 11346323 | Background | Aaron LA, Buchwald D. A review of the evidence for overlap among unexplained clinical conditions. Ann Intern Med. 2001 May 1;134(9 Pt 2):868-81. doi: 10.7326/0003-4819-134-9_part_2-200105011-00011. |
| 9146002 | Background | Alagiri M, Chottiner S, Ratner V, Slade D, Hanno PM. Interstitial cystitis: unexplained associations with other chronic disease and pain syndromes. Urology. 1997 May;49(5A Suppl):52-7. doi: 10.1016/s0090-4295(99)80332-x. |
| 23234637 | Background | Bullones Rodriguez MA, Afari N, Buchwald DS; National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Urological Chronic Pelvic Pain. Evidence for overlap between urological and nonurological unexplained clinical conditions. J Urol. 2013 Jan;189(1 Suppl):S66-74. doi: 10.1016/j.juro.2012.11.019. |
| 9201654 | Background | Clauw DJ, Schmidt M, Radulovic D, Singer A, Katz P, Bresette J. The relationship between fibromyalgia and interstitial cystitis. J Psychiatr Res. 1997 Jan-Feb;31(1):125-31. doi: 10.1016/s0022-3956(96)00051-9. |
| 17943887 | Background | Dawson TE, Jamison J. Intravesical treatments for painful bladder syndrome/ interstitial cystitis. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD006113. doi: 10.1002/14651858.CD006113.pub2. |
| 26272202 | Background | Pazin C, de Souza Mitidieri AM, Silva AP, Gurian MB, Poli-Neto OB, Rosa-E-Silva JC. Treatment of bladder pain syndrome and interstitial cystitis: a systematic review. Int Urogynecol J. 2016 May;27(5):697-708. doi: 10.1007/s00192-015-2815-5. Epub 2015 Aug 14. |
| 22786518 | Background | Chaparro LE, Wiffen PJ, Moore RA, Gilron I. Combination pharmacotherapy for the treatment of neuropathic pain in adults. Cochrane Database Syst Rev. 2012 Jul 11;2012(7):CD008943. doi: 10.1002/14651858.CD008943.pub2. |
| 26816864 | Background | Cvach K, Rosamilia A. Review of intravesical therapies for bladder pain syndrome/interstitial cystitis. Transl Androl Urol. 2015 Dec;4(6):629-37. doi: 10.3978/j.issn.2223-4683.2015.10.07. |
| 26590137 | Background | Barua JM, Arance I, Angulo JC, Riedl CR. A systematic review and meta-analysis on the efficacy of intravesical therapy for bladder pain syndrome/interstitial cystitis. Int Urogynecol J. 2016 Aug;27(8):1137-47. doi: 10.1007/s00192-015-2890-7. Epub 2015 Nov 20. |
| 15711286 | Background | Soucy F, Gregoire M. Efficacy of prednisone for severe refractory ulcerative interstitial cystitis. J Urol. 2005 Mar;173(3):841-3; discussion 843. doi: 10.1097/01.ju.0000153612.14639.19. |
| 19364425 | Background | Cox M, Klutke JJ, Klutke CG. Assessment of patient outcomes following submucosal injection of triamcinolone for treatment of Hunner's ulcer subtype interstitial cystitis. Can J Urol. 2009 Apr;16(2):4536-40. |
| 33831942 | Derived | Cardenas-Trowers OO, Abraham AG, Dotson TK, Houlette BA, Gaskins JT, Francis SL. Bladder Instillations With Triamcinolone Acetonide for Interstitial Cystitis-Bladder Pain Syndrome: A Randomized Controlled Trial. Obstet Gynecol. 2021 May 1;137(5):810-819. doi: 10.1097/AOG.0000000000004348. |
| 32734597 | Derived | Imamura M, Scott NW, Wallace SA, Ogah JA, Ford AA, Dubos YA, Brazzelli M. Interventions for treating people with symptoms of bladder pain syndrome: a network meta-analysis. Cochrane Database Syst Rev. 2020 Jul 30;7(7):CD013325. doi: 10.1002/14651858.CD013325.pub2. |
| Bladder Instillation WITHOUT Triamcinolone Acetonide |
Six weekly bladder instillations WITHOUT triamcinolone acetonide: mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Bladder Instillation WITHOUT Triamcinolone Acetonide | Six weekly bladder instillations of standard cocktail without triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL). Bladder instillation WITHOUT triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL). |
|
|
| Secondary | Pelvic Pain and Urgency/Frequency (PUF) Questionnaire | Total scores range: 0-35 (0= no symptoms to 35= the most severe symptoms) | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported |
|
|
|
| Secondary | Overactive Bladder Questionnaire (OAB-q) | Total scores range: 0-100 (higher scores on the symptom-severity scale suggestive of greater severity of symptoms and higher scores on the quality-of-life scale suggestive of better quality of life) | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported |
|
|
|
| Secondary | Pelvic Floor Distress Inventory (PFDI) | 20 question self-administered questionnaire on the presence and absence of pelvic floor symptoms. Score ranges from 0 (least distress) to 300 (most distress). | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported |
|
|
|
| Secondary | Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire | Measures sexual function in women with pelvic floor disorders. Queries about arousal, orgasm, partner-related issues, sexual quality, and desire. The tool also takes into account those who are not sexually active. The questionnaire was used in the study solely to determine if patients had improved dyspareunia (as a categorical variable). | Posted | Number | participants | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported |
|
|
|
| Secondary | Change From Baseline in Treatment Response as Measured by the Visual Analogue Scale (VAS) for Pain | VAS is measured on marking on a 10-centimeter (cm) ruler (measured in cm, 0= no pain and 10= most severe pain possible) | Posted | Mean | Standard Deviation | score on a scale | Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported |
|
|
|
| Secondary | Number of Participants With at Least One Adverse Event | Adverse events will only be those determined to be related to the study drug | Posted | Count of Participants | Participants | End of study (6 weeks) |
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 5 |
| 45 |
| EG001 | Bladder Instillation WITHOUT Triamcinolone Acetonide | Six weekly bladder instillations of standard cocktail without triamcinolone acetonide. Standard cocktail= heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL). Bladder instillation WITHOUT triamcinolone acetonide: Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL). | 0 | 45 | 0 | 45 | 1 | 45 |
| Urinary tract infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Anxiety attack | Psychiatric disorders | Systematic Assessment |
|
| Strong bladder spasms | Renal and urinary disorders | Systematic Assessment |
|
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014221 |
| Triamcinolone |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |