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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)

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

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

Studies a U.S. FDA-regulated Device Product

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

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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