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Bladder Capacity as Objective Measure of Intravesical Treatment of Newly Diagnosed IC

Primary Purpose

Interstitial Cystitis, Painful Bladder Syndrome

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
bupivacaine, triamcinolone, and heparin (BTH)
dimethyl sulfoxide (DMSO)
Sponsored by
NorthShore University HealthSystem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring dimethyl sulfoxide (DMSO), Intravesical instillations, bupivacaine, triamcinolone, and heparin (BTH), Bladder instillations

Eligibility Criteria

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

Inclusion Criteria:

  • newly diagnosed interstitial cystitis/painful bladder syndrome

Exclusion Criteria:

  • History of pelvic radiation, a history of bladder cancer, or a history of bladder resection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    dimethyl sulfoxide (DMSO)

    bupivacaine, triamcinolone, and heparin (BTH)

    Arm Description

    Six weekly bladder instillations with 50mL of DMSO and 1mL of triamcinolone (10mg/mL)

    Six weekly bladder instillations with 30mL of 0.5% bupivacaine (5mg/mL), 2mL triamcinolone (10mg/mL), and 2mL Heparin (10,000units/mL)

    Outcomes

    Primary Outcome Measures

    Reduction of at least 29.5% in ICSI score
    reduction of at least 29.5% in ICSI score

    Secondary Outcome Measures

    Bladder capacity
    measurement of bladder capacity as determined by retro fill volume

    Full Information

    First Posted
    January 24, 2022
    Last Updated
    January 24, 2022
    Sponsor
    NorthShore University HealthSystem
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05223244
    Brief Title
    Bladder Capacity as Objective Measure of Intravesical Treatment of Newly Diagnosed IC
    Official Title
    Bladder Capacity as an Objective Measure of Response to Intravesical Treatment of Newly Diagnosed Interstitial Cystitis: a Prospective, Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1, 2011 (Actual)
    Primary Completion Date
    April 1, 2019 (Actual)
    Study Completion Date
    March 30, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    NorthShore University HealthSystem

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    A comparative study of subjective outcomes following intravesical treatment of interstitial cystitis (IC) is lacking in the literature. Furthermore, an objective measure to determine the efficacy of intravesical treatment for interstitial cystitis has yet to be defined. Change in bladder capacity following therapy has been investigated; however, a formal statistical analysis of its utility in determining efficacy has yet to be performed. The primary objective of this prospective, randomized study is to determine whether there is a significant difference in subjective improvement in IC symptoms in women with newly diagnosed IC when treated with either dimethyl sulfoxide (DMSO) or bupivacaine, triamcinolone, and heparin (BTH) instillations. The secondary objective is to determine whether change in bladder capacity can be used as an objective measure of response to intravesical therapy for newly diagnosed interstitial cystitis. Our long-term goals are to improve the scientific understanding of therapy for interstitial cystitis, to improve patient counseling prior to initiation of treatment, and to better identify patients likely to receive inadequate relief of symptoms following intravesical treatment so that an alternative treatment can be pursued.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Interstitial Cystitis, Painful Bladder Syndrome
    Keywords
    dimethyl sulfoxide (DMSO), Intravesical instillations, bupivacaine, triamcinolone, and heparin (BTH), Bladder instillations

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    At each of the six weekly treatment visits, bladder capacity was determined, followed by the intravesical treatment of either DMSO or BTH.
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Masking Description
    Patients, investigators, and outcomes assessors were blinded to treatment patients received
    Allocation
    Randomized
    Enrollment
    83 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    dimethyl sulfoxide (DMSO)
    Arm Type
    Active Comparator
    Arm Description
    Six weekly bladder instillations with 50mL of DMSO and 1mL of triamcinolone (10mg/mL)
    Arm Title
    bupivacaine, triamcinolone, and heparin (BTH)
    Arm Type
    Experimental
    Arm Description
    Six weekly bladder instillations with 30mL of 0.5% bupivacaine (5mg/mL), 2mL triamcinolone (10mg/mL), and 2mL Heparin (10,000units/mL)
    Intervention Type
    Drug
    Intervention Name(s)
    bupivacaine, triamcinolone, and heparin (BTH)
    Intervention Description
    30mL of 0.5% bupivacaine (5mg/mL), 2mL triamcinolone (10mg/mL), and 2mL Heparin (10,000units/mL)
    Intervention Type
    Drug
    Intervention Name(s)
    dimethyl sulfoxide (DMSO)
    Intervention Description
    50mL of DMSO and 1mL of triamcinolone (10mg/mL)
    Primary Outcome Measure Information:
    Title
    Reduction of at least 29.5% in ICSI score
    Description
    reduction of at least 29.5% in ICSI score
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Bladder capacity
    Description
    measurement of bladder capacity as determined by retro fill volume
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: newly diagnosed interstitial cystitis/painful bladder syndrome Exclusion Criteria: History of pelvic radiation, a history of bladder cancer, or a history of bladder resection

    12. IPD Sharing Statement

    Learn more about this trial

    Bladder Capacity as Objective Measure of Intravesical Treatment of Newly Diagnosed IC

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