Clinical trial NCT03463915: Clinical Trial Comparing Two Bladder Instillations for IC/BPS
Official title: Randomized Controlled Trial Comparing Two Different Bladder Instillation Treatments for Interstitial Cystitis/Bladder Pain Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Interstitial Cystitis
Bladder Pain Syndrome
Keywords: Interstitial cystitis
Bladder pain syndrome
IC/BPS
Women
Pelvic pain
Urologic pain
Bladder instillation
Kenalog
Steroid
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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. 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.

Eligibility 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

Primary outcomes:
measure: Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire
timeFrame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Secondary outcomes:
measure: Pelvic Pain and Urgency/Frequency (PUF) Questionnaire
timeFrame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
measure: Overactive Bladder Questionnaire (OAB-q)
timeFrame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
measure: Pelvic Floor Distress Inventory (PFDI)
timeFrame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
measure: Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire
timeFrame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
measure: Change From Baseline in Treatment Response as Measured by the Visual Analogue Scale (VAS) for Pain
timeFrame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
measure: Number of Participants With at Least One Adverse Event
timeFrame: End of study (6 weeks)
Other outcomes:
Locations:
city: Louisville
country: United States
facility: University of Louisville Urogynecology at Springs Medical Center
state: Kentucky
Study officials:
affiliation: University of Louisville
name: Olivia Cardenas-Trowers, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Louisville
name: Sean Francis, M.D.
role: PRINCIPAL_INVESTIGATOR
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