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

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

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.

Study Overview

• Status: Completed
• Conditions: Interstitial Cystitis; Painful Bladder Syndrome
• Intervention / Treatment: Drug: dimethyl sulfoxide (DMSO); Drug: bupivacaine, triamcinolone, and heparin (BTH)

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: dimethyl sulfoxide (DMSO); Six weekly bladder instillations with 50mL of DMSO and 1mL of triamcinolone (10mg/mL)	Drug: dimethyl sulfoxide (DMSO); 50mL of DMSO and 1mL of triamcinolone (10mg/mL)
EXPERIMENTAL: 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)	Drug: bupivacaine, triamcinolone, and heparin (BTH); 30mL of 0.5% bupivacaine (5mg/mL), 2mL triamcinolone (10mg/mL), and 2mL Heparin (10,000units/mL)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NorthShore University HealthSystem

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2011
• Primary Completion (ACTUAL): April 1, 2019
• Study Completion (ACTUAL): March 30, 2020

Study Registration Dates

• First Submitted: January 24, 2022
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (ACTUAL): February 3, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 3, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: dimethyl sulfoxide (DMSO); Intravesical instillations; bupivacaine, triamcinolone, and heparin (BTH); Bladder instillations
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Cystitis; Cystitis, Interstitial; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protective Agents; Anesthetics, Local; Anticoagulants; Antioxidants; Free Radical Scavengers; Cryoprotective Agents; Heparin; Triamcinolone; Bupivacaine; Dimethyl Sulfoxide
• Other Study ID Numbers: EH11-081

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No