A Prospective Trial Comparing the Response to Hyperbaric Oxygen Treatment in Patients With Ulcerative and Non-Ulcerative Interstitial Cystitis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Kenneth Peters, MD
- Enrollment
- 8
- Locations
- 2
- Primary Endpoint
- Global Response Assessment (GRA)
Study Overview
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 patients with interstitial cystitis.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Global Response Assessment (GRA)
Time Frame: 3 months post treatment
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Kenneth Peters, MD
Principal Investigator
William Beaumont Hospitals