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Clinical Trial Comparing Two Bladder Instillations for IC/BPS

NCT03463915 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-09-01

Study results available
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Summary

Interstitial cystitis/bladder pain syndrome (IC/BPS) is a condition that results in long-term bladder and pelvic pain. IC/BPS affects women more often than men. How the disorder develops is not completely known. Bladder instillation is a commonly used treatment in which a mixture of different ingredients are passed into the bladder to help IC/BPS symptoms. There is room to learn more about bladder instillations and which ingredients in them work best. The purpose of this study is to compare the effectiveness of a bladder instillation that contains a steroid (triamcinolone acetonide) to a bladder instillation that does not contain a steroid to treat IC/BPS in women. The study hypothesis is that women with IC/BPS treated with bladder instillations that contain a steroid will have improved outcomes compared to women treated with bladder instillations that do not contain a steroid.

Conditions

  • Interstitial Cystitis
  • Bladder Pain Syndrome

Interventions

DRUG

Bladder instillation WITH triamcinolone acetonide

Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).

DRUG

Bladder instillation WITHOUT triamcinolone acetonide

Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).

Sponsors & Collaborators

  • Olivia Cardenas-Trowers, M.D.

    lead OTHER

Principal Investigators

  • Olivia Cardenas-Trowers, M.D. · University of Louisville

  • Sean Francis, M.D. · University of Louisville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-25
Primary Completion
2020-10-23
Completion
2020-10-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03463915 on ClinicalTrials.gov