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

NorthShore University HealthSystem

Status and phase: Completed; Phase 4

Conditions: Interstitial Cystitis; Painful Bladder Syndrome

Treatments: Drug: bupivacaine, triamcinolone, and heparin (BTH); Drug: dimethyl sulfoxide (DMSO)

Study type: Interventional

Funder types: Other

Identifiers

NCT05223244

EH11-081

Details and patient eligibility

About

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.

Enrollment: 83 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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83 participants in 2 patient groups

dimethyl sulfoxide (DMSO)

Active Comparator group

Description:

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

Treatment:

Drug: dimethyl sulfoxide (DMSO)

bupivacaine, triamcinolone, and heparin (BTH)

Experimental group

Description:

Six weekly bladder instillations with 30mL of 0.5% bupivacaine (5mg/mL), 2mL triamcinolone (10mg/mL), and 2mL Heparin (10,000units/mL)

Treatment:

Drug: bupivacaine, triamcinolone, and heparin (BTH)