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Trial record 89 of 158 for:    interstitial cystitis

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
Sponsor:
Information provided by (Responsible Party):
Olivia Cardenas-Trowers, M.D., University of Louisville

Brief Summary:
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.

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

Detailed Description:

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.[1] 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.[2] 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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)

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women 18 years and older
  • Women with IC/BPS who have a score of ≥ 6 on either index (problem or symptom index) of the O'Leary-Sant questionnaire who have selected bladder instillations as part of their IC/BPS treatment
  • Suitability for follow-up

Exclusion Criteria:

  • Contraindications and/or allergies to the ingredients used in the bladder instillations
  • Diagnosis of idiopathic thrombocytopenic purpura
  • Does not desire to undergo bladder instillation therapy or unwilling to undergo bladder instillation therapy on schedule mandated by study
  • Have a known alternative diagnosis explaining bladder pain symptoms that would preclude the diagnosis of IC/BPS (e.g. radiation cystitis, active urinary tract infection with bacteria or fungus treated within last 2 weeks or diagnosed at index visit, bladder injury or trauma within the last 30 days)
  • Inability to speak or read English
  • Bladder instillation within the past 4 weeks

Information from the National Library of Medicine

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


Contacts
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Contact: Alyce Goodman-Abraham, A.P.R.N. (502) 588-7660 contactus@ulp.org

Locations
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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    contactus@ulp.org   
Principal Investigator: Olivia Cardenas-Trowers, M.D.         
Principal Investigator: Kate V Meriwether, M.D.         
Sponsors and Collaborators
Olivia Cardenas-Trowers, M.D.
Investigators
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Principal Investigator: Olivia Cardenas-Trowers, M.D. University of Louisville
Principal Investigator: Kate Meriwether, M.D. University of Louisville

Publications:

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Responsible Party: Olivia Cardenas-Trowers, M.D., Sponsor-Investigator, University of Louisville
ClinicalTrials.gov Identifier: NCT03463915     History of Changes
Other Study ID Numbers: 18.0209
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified raw data and other supporting materials will be made available to approved investigators. Email requests to olivia.cardenas-trowers@louisville.edu.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available beginning 1 month and ending 24 months following article publication.
Access Criteria: 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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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Olivia Cardenas-Trowers, M.D., University of Louisville:
Interstitial cystitis
Bladder pain syndrome
IC/BPS
Women
Pelvic pain
Urologic pain
Bladder instillation
Kenalog
Steroid

Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Syndrome
Somatoform Disorders
Disease
Pathologic Processes
Mental Disorders
Urinary Bladder Diseases
Urologic Diseases
Bupivacaine
Lidocaine
Heparin
Calcium heparin
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents