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

Study Overview
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Brief Summary
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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.

Official Title
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Bladder Capacity as an Objective Measure of Response to Intravesical Treatment of Newly Diagnosed Interstitial Cystitis: a Prospective, Randomized Trial

Conditions
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Interstitial Cystitis, Painful Bladder Syndrome

Intervention / Treatment
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* Drug: bupivacaine, triamcinolone, and heparin (BTH)
* Drug: dimethyl sulfoxide (DMSO)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dimethyl sulfoxide (DMSO)<br>Six weekly bladder instillations with 50mL of DMSO and 1mL of triamcinolone (10mg/mL) | Drug: dimethyl sulfoxide (DMSO)<br>* 50mL of DMSO and 1mL of triamcinolone (10mg/mL)<br>|
| Experimental: bupivacaine, triamcinolone, and heparin (BTH)<br>Six weekly bladder instillations with 30mL of 0.5% bupivacaine (5mg/mL), 2mL triamcinolone (10mg/mL), and 2mL Heparin (10,000units/mL) | Drug: bupivacaine, triamcinolone, and heparin (BTH)<br>* 30mL of 0.5% bupivacaine (5mg/mL), 2mL triamcinolone (10mg/mL), and 2mL Heparin (10,000units/mL)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of at least 29.5% in ICSI score | reduction of at least 29.5% in ICSI score | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bladder capacity | measurement of bladder capacity as determined by retro fill volume | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dimethyl sulfoxide (DMSO), Intravesical instillations, bupivacaine, triamcinolone, and heparin (BTH), Bladder instillations