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



Status:Active, not recruiting
Conditions:Other Indications, Urology
Therapuetic Areas:Nephrology / Urology, Other
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2011
End Date:December 2015

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

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.

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.
We found this trial at
1
site
Royal Oak, Michigan 48073
?
mi
from
Royal Oak, MI
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