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

NCT ID: NCT05223244

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-01
• Study Completion Date: 2020-03-30

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.

Conditions

Interstitial Cystitis; Painful Bladder Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

dimethyl sulfoxide (DMSO)

Six weekly bladder instillations with 50mL of DMSO and 1mL of triamcinolone (10mg/mL)

Group Type: ACTIVE_COMPARATOR

dimethyl sulfoxide (DMSO)

Intervention Type: DRUG

50mL of DMSO and 1mL of triamcinolone (10mg/mL)

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)

Group Type: EXPERIMENTAL

bupivacaine, triamcinolone, and heparin (BTH)

Intervention Type: DRUG

30mL of 0.5% bupivacaine (5mg/mL), 2mL triamcinolone (10mg/mL), and 2mL Heparin (10,000units/mL)

Interventions

bupivacaine, triamcinolone, and heparin (BTH)

30mL of 0.5% bupivacaine (5mg/mL), 2mL triamcinolone (10mg/mL), and 2mL Heparin (10,000units/mL)

Intervention Type: DRUG

dimethyl sulfoxide (DMSO)

50mL of DMSO and 1mL of triamcinolone (10mg/mL)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Endeavor Health

OTHER

Sponsor Role: lead

Responsible Party

Adam Gafni-Kane

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

EH11-081

Identifier Type: -

Identifier Source: org_study_id