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Clinical Trial Comparing Two Bladder Instillations for IC/BPS

Primary Purpose

Interstitial Cystitis, Bladder Pain Syndrome

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bladder instillation WITH triamcinolone acetonide
Bladder instillation WITHOUT triamcinolone acetonide
Sponsored by
Olivia Cardenas-Trowers, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring Interstitial cystitis, Bladder pain syndrome, IC/BPS, Women, Pelvic pain, Urologic pain, Bladder instillation, Kenalog, Steroid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Louisville Urogynecology at Springs Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bladder instillation WITH triamcinolone acetonide

Bladder instillation WITHOUT triamcinolone acetonide

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Pelvic Pain and Urgency/Frequency (PUF) Questionnaire
Total scores range: 0-35 (0= no symptoms to 35= the most severe symptoms)
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)
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).
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).
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)
Number of Participants With at Least One Adverse Event
Adverse events will only be those determined to be related to the study drug

Full Information

First Posted
February 28, 2018
Last Updated
August 8, 2021
Sponsor
Olivia Cardenas-Trowers, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT03463915
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 25, 2019 (Actual)
Primary Completion Date
October 23, 2020 (Actual)
Study Completion Date
October 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Olivia Cardenas-Trowers, M.D.

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Cystitis, Bladder Pain Syndrome
Keywords
Interstitial cystitis, Bladder pain syndrome, IC/BPS, Women, Pelvic pain, Urologic pain, Bladder instillation, Kenalog, Steroid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bladder instillation WITH triamcinolone acetonide
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Bladder instillation WITHOUT triamcinolone acetonide
Arm Type
Placebo Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Bladder instillation WITH triamcinolone acetonide
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Bladder instillation WITHOUT triamcinolone acetonide
Intervention Description
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 Measure Information:
Title
Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire
Description
Total scores range: 0-36 (0= no symptoms to 36= the most severe symptoms)
Time Frame
Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Secondary Outcome Measure Information:
Title
Pelvic Pain and Urgency/Frequency (PUF) Questionnaire
Description
Total scores range: 0-35 (0= no symptoms to 35= the most severe symptoms)
Time Frame
Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Title
Overactive Bladder Questionnaire (OAB-q)
Description
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)
Time Frame
Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Title
Pelvic Floor Distress Inventory (PFDI)
Description
20 question self-administered questionnaire on the presence and absence of pelvic floor symptoms. Score ranges from 0 (least distress) to 300 (most distress).
Time Frame
Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Title
Sexual Function Measured by the Pelvic Organ Prolapse Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR) Questionnaire
Description
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).
Time Frame
Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Title
Change From Baseline in Treatment Response as Measured by the Visual Analogue Scale (VAS) for Pain
Description
VAS is measured on marking on a 10-centimeter (cm) ruler (measured in cm, 0= no pain and 10= most severe pain possible)
Time Frame
Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
Title
Number of Participants With at Least One Adverse Event
Description
Adverse events will only be those determined to be related to the study drug
Time Frame
End of study (6 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivia Cardenas-Trowers, M.D.
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sean Francis, M.D.
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville Urogynecology at Springs Medical Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data will be available beginning 1 month and ending 24 months following article publication.
IPD Sharing 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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Clinical Trial Comparing Two Bladder Instillations for IC/BPS

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