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Hyperbaric Oxygen Therapy for Inflammatory Conditions of the Urinary Bladder

NCT03143920 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2022-07-11

No results posted yet for this study

Summary

Pilot study to determine feasibility for treating patients with two chronic inflammatory conditions of the urinary bladder: chronic interstitial cystitis and recurrent urinary tract infections using a standardized hyperbaric oxygen treatment plan. Presently there are no good treatments for these conditions and hyperbaric oxygen may be a safe and readily accessible therapy as it has proven successful an another type of chronic inflammatory condition of the urinary bladder known as "radiation cystitis". The study will determine if patients will consider this an acceptable treatment for their conditions and that it is well tolerated.

Conditions

  • Chronic Interstitial Cystitis
  • Painful Bladder Syndrome
  • Recurrent Urinary Tract Infection

Interventions

COMBINATION_PRODUCT

Hyperbaric Oxygen Therapy-

Hyperbaric oxygen therapy provides 100% medical grade oxygen at 2.4 atmospheres of absolute pressure with a Class A multiple person chamber or Class B single person chamber. Hyperbaric chambers are classified as a Class II medical device and have been FDA cleared.

Sponsors & Collaborators

Principal Investigators

  • Ian R Grover, MD · University of California, San Diego

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2022-07-07
Completion
2022-07-07
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03143920 on ClinicalTrials.gov