Prospective Trial Comparing Response to Hyperbaric Oxygen Treatment in Patients With Interstitial Cystitis
Completed · Phase 2
Conditions studied: Interstitial Cystitis
In brief
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.
Key facts
- Study ID
- NCT01479725
- Run by
- Kenneth Peters, MD
- People needed
- 8
- Starts
- 2011-03-01
- Expected to finish
- 2013-05-01
- Last updated by the study team
- 2017-03-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Beaumont Hospital — Royal Oak, Michigan, United States
Full record on ClinicalTrials.gov
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