Status:
COMPLETED
Prospective Trial Comparing Response to Hyperbaric Oxygen Treatment in Patients With Interstitial Cystitis
Lead Sponsor:
Kenneth Peters, MD
Collaborating Sponsors:
Corewell Health East
Conditions:
Interstitial Cystitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 pa...
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01479725
Start Date
March 1 2011
End Date
May 1 2013
Last Update
March 3 2017
Active Locations (1)
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1
Beaumont Hospital
Royal Oak, Michigan, United States, 48073