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
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
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
NCT ID
NCT05223244
First Posted
January 24, 2022
Last Updated
January 24, 2022
Sponsor
NorthShore University HealthSystem
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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