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

NCT05223244 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2022-02-03

No results posted yet for this study

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

Interventions

DRUG

bupivacaine, triamcinolone, and heparin (BTH)

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

DRUG

dimethyl sulfoxide (DMSO)

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

Sponsors & Collaborators

  • Endeavor Health

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-01
Primary Completion
2019-04-01
Completion
2020-03-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05223244 on ClinicalTrials.gov