Clinical Trial Comparing Two Bladder Instillations for IC/BPS

August 8, 2021 updated by: Olivia Cardenas-Trowers, M.D.

Randomized Controlled Trial Comparing Two Different Bladder Instillation Treatments for Interstitial Cystitis/Bladder Pain Syndrome

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • University of Louisville Urogynecology at Springs Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Treatment Response as Measured by the Total Score on the O'Leary-Sant Questionnaire
Time Frame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pelvic Pain and Urgency/Frequency (PUF) Questionnaire
Time Frame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
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)
Time Frame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
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)
Time Frame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
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
Time Frame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
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
Time Frame: Assessed at baseline, 3 and 6 weeks; change from baseline to week 6 reported
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
Time Frame: End of study (6 weeks)
Adverse events will only be those determined to be related to the study drug
End of study (6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Olivia Cardenas-Trowers, M.D.

Investigators

  • Principal Investigator: Olivia Cardenas-Trowers, M.D., University Of Louisville
  • Principal Investigator: Sean Francis, M.D., University Of Louisville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2019

Primary Completion (Actual)

October 23, 2020

Study Completion (Actual)

October 23, 2020

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

March 6, 2018

First Posted (Actual)

March 13, 2018

Study Record Updates

Last Update Posted (Actual)

September 1, 2021

Last Update Submitted That Met QC Criteria

August 8, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18.0209

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Interstitial Cystitis

Clinical Trials on Bladder instillation WITH triamcinolone acetonide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe