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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Trial Comparing the Response to Hyperbaric Oxygen Treatment in Patients With Ulcerative and Non-Ulcerative Interstitial Cystitis

Conditions
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Interstitial Cystitis

Intervention / Treatment
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* Procedure: HBOT


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ulcerative IC<br>HBOT for ulcerative IC | Procedure: HBOT<br>* HBOT<br>* Other names: hyperbaric oxygen therapy;|
| Experimental: Non-Ulcerative IC<br>HBOT for non-ulcerative IC | Procedure: HBOT<br>* HBOT<br>* Other names: hyperbaric oxygen therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interstitial cystitis