Clinical Trial Comparing Two Bladder Instillations for IC/BPS
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|ClinicalTrials.gov Identifier: NCT03463915|
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : March 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Interstitial Cystitis Bladder Pain Syndrome||Drug: Bladder instillation WITH triamcinolone acetonide Drug: Bladder instillation WITHOUT triamcinolone acetonide||Phase 3|
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.[3-6] Although several options exist to treat IC/BPS, therapeutic effects are often transient.[7,8] Previous studies in chronic pain disorders have shown that multimodal treatment is more effective than single-agent treatment,[9,10] 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 are 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, is limited.[11,12] 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.[13,14] 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Randomized Controlled Trial Comparing Two Different Bladder Instillation Treatments for Interstitial Cystitis/Bladder Pain Syndrome|
|Actual Study Start Date :||January 25, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Active Comparator: 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).
Drug: 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).
Placebo Comparator: 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).
Drug: 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).
- Change from baseline in treatment response as measured by the total score on the O'Leary-Sant questionnaire [ Time Frame: Baseline, 3 weeks, and 6 weeks ]Total scores range: 0-36 (0= no symptoms to 36= the most severe symptoms)
- Pelvic pain and urgency/frequency (PUF) questionnaire [ Time Frame: Baseline, 3 weeks, and 6 weeks ]Total scores range: 0-35 (0= no symptoms to 35= the most severe symptoms)
- Overactive bladder questionnaire (OAB-q) [ Time Frame: Baseline, 3 weeks, and 6 weeks ]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)
- Pelvic floor distress inventory (PFDI) [ Time Frame: Baseline, 3 weeks, and 6 weeks ]20 question self-administered questionnaire on the presence and abscence of pelvic floor symptoms
- Sexual function measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) questionnaire [ Time Frame: Baseline, 3 weeks, and 6 weeks ]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
- Change from baseline in treatment response as measured by the Visual Analogue Scale (VAS) for pain [ Time Frame: Baseline, 3 weeks, and 6 weeks ]VAS is measured on marking on a 10-centimeter (cm) ruler (measured in cm, 0= no pain and 10= most severe pain possible)
- Number of participants with at least one adverse event [ Time Frame: End of study (6 weeks) ]Adverse events will only be those determined to be related to the study drug
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463915
|Contact: Alyce Goodman-Abraham, A.P.R.N.||(502) email@example.com|
|United States, Kentucky|
|University of Louisville Urogynecology at Springs Medical Center||Recruiting|
|Louisville, Kentucky, United States, 40205|
|Contact: Alyce Goodman-Abraham, A.P.R.N. 502-588-7660 firstname.lastname@example.org|
|Principal Investigator: Olivia Cardenas-Trowers, M.D.|
|Principal Investigator: Kate V Meriwether, M.D.|
|Principal Investigator:||Olivia Cardenas-Trowers, M.D.||University of Louisville|
|Principal Investigator:||Kate Meriwether, M.D.||University of Louisville|