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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-05-31

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.

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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.

Conditions

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Interstitial Cystitis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ulcerative IC

HBOT for ulcerative IC

Group Type EXPERIMENTAL

HBOT

Intervention Type PROCEDURE

HBOT

Non-Ulcerative IC

HBOT for non-ulcerative IC

Group Type EXPERIMENTAL

HBOT

Intervention Type PROCEDURE

HBOT

Interventions

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HBOT

Intervention Type PROCEDURE

Other Intervention Names

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hyperbaric oxygen therapy

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No