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

Phase 4

Completed

• Conditions: Interstitial Cystitis; Painful Bladder Syndrome
• Interventions: Drug: bupivacaine, triamcinolone, and heparin (BTH); Drug: dimethyl sulfoxide (DMSO)

• Registration Number: NCT05223244
• Lead Sponsor: NorthShore University HealthSystem

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-01
• Primary Completion: 2019-04-01
• Study Completion: 2020-03-30
• Status Verified: 2022-01
• Study First Submitted: 2022-01-24
• Study First Submitted QC: 2022-01-24
• Last Update Submitted: 2022-01-24
• Study First Posted: 2022-02-03
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 83

Inclusion Criteria

• newly diagnosed interstitial cystitis/painful bladder syndrome

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bupivacaine, triamcinolone, and heparin (BTH)	bupivacaine, triamcinolone, and heparin (BTH)	Six weekly bladder instillations with 30mL of 0.5% bupivacaine (5mg/mL), 2mL triamcinolone (10mg/mL), and 2mL Heparin (10,000units/mL)
dimethyl sulfoxide (DMSO)	dimethyl sulfoxide (DMSO)	Six weekly bladder instillations with 50mL of DMSO and 1mL of triamcinolone (10mg/mL)

Primary Outcome Measures

Name	Time	Method
Reduction of at least 29.5% in ICSI score	6 weeks	reduction of at least 29.5% in ICSI score

Secondary Outcome Measures

Name	Time	Method
Bladder capacity	6 weeks	measurement of bladder capacity as determined by retro fill volume