Prospective Trial Comparing Response to Hyperbaric Oxygen Treatment in Patients With Interstitial Cystitis

Kenneth Peters, MD8 enrolled

Overview

To review the results of Hyperbaric Oxygen therapy (HBOT) on the symptoms of interstitial cystitis (IC). To determine if there is greater symptom improvement in the ulcerative vs the non-ulcerative patients with interstitial cystitis.

There are multiple published studies outside of the United States on HBOT for treatment of interstitial cystitis. None of these studies compares ulcerative IC and non-ulcerative IC.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Interstitial Cystitis

Interventions

HBOTPROCEDURE

HBOT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Interstitial cystitis. * Urinary frequency of at least 8 times per 24 hours period. * Patients with ulcerative IC must have undergone previous biopsy negative for cancer. * Patients must agree to not begin any additional treatment for IC until study completion. Exclusion Criteria: * Absolute or relative contraindication to hyperbaric oxygen treatment. * Patients dependent on intermittent catheterization or indwelling catheter to empty bladder. * Any imminent change in residence, which could compromise compliance. * Unlikely to be compliant due to unmanaged medical or psychological problems. * Severe debilitating concurrent medical conditions. * A history of pelvic radiation, bladder stone, bladder cancer or cancer in situ, or urethral cancer. * Precious bladder or neurologic surgery which has affected bladder function. * Currently has an active urethral stone, ureteral stone or urethral diverticulum. * Subject misses more than 10 treatments. * Severe claustrophobia.

Locations (1)

Beaumont Hospital

Royal Oak, Michigan, United States

Outcomes

Primary Outcomes

Global Response Assessment (GRA)

The GRA measures overall improvement with therapy. The patient's response describes their current condition compared to before they received hyperbaric oxygen therapy (HBOT). Responses are: 1 Markedly Worse, 2 Moderately Worse, 3 Mildly Worse, 4 Unchanged, 5 Mildly Better, 6 Moderately Better and 7 Markedly Better.

Time frame: 3 months post treatment

Data from ClinicalTrials.gov

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