Interstitial Cystitis
Conditions
Keywords
interstitial cystitis
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.
Interventions
PROCEDUREHBOT
HBOT
Sponsors
Corewell Health East
Kenneth Peters, MD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Response Assessment (GRA) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ulcerative IC HBOT for ulcerative IC
HBOT: HBOT | 6 |
| Non-Ulcerative IC HBOT for non-ulcerative IC
HBOT: HBOT | 2 |
| Total | 8 |
Baseline characteristics
| Characteristic | Ulcerative IC | Non-Ulcerative IC | Total |
|---|---|---|---|
| Age, Continuous | 54.3 years | 53 years | 54 years |
| Gender Female | 4 Participants | 2 Participants | 6 Participants |
| Gender Male | 2 Participants | 0 Participants | 2 Participants |
| Region of Enrollment United States | 6 participants | 2 participants | 8 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 2 |
| serious Total, serious adverse events | 0 / 6 | 0 / 2 |
Outcome results
Primary
Global Response Assessment (GRA)
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.
Time frame: 3 months post treatment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ulcerative IC | Global Response Assessment (GRA) | Mildy Worse | 0 number of participants |
| Ulcerative IC | Global Response Assessment (GRA) | Mildly Better | 4 number of participants |
| Ulcerative IC | Global Response Assessment (GRA) | Markedly Better | 0 number of participants |
| Ulcerative IC | Global Response Assessment (GRA) | Moderately Worse | 0 number of participants |
| Ulcerative IC | Global Response Assessment (GRA) | Unchanged | 0 number of participants |
| Ulcerative IC | Global Response Assessment (GRA) | Markedly Worse | 1 number of participants |
| Ulcerative IC | Global Response Assessment (GRA) | Moderately Better | 1 number of participants |
| Non-Ulcerative IC | Global Response Assessment (GRA) | Markedly Worse | 0 number of participants |
| Non-Ulcerative IC | Global Response Assessment (GRA) | Unchanged | 1 number of participants |
| Non-Ulcerative IC | Global Response Assessment (GRA) | Markedly Better | 1 number of participants |
| Non-Ulcerative IC | Global Response Assessment (GRA) | Moderately Better | 0 number of participants |
| Non-Ulcerative IC | Global Response Assessment (GRA) | Mildy Worse | 0 number of participants |
| Non-Ulcerative IC | Global Response Assessment (GRA) | Moderately Worse | 0 number of participants |
| Non-Ulcerative IC | Global Response Assessment (GRA) | Mildly Better | 0 number of participants |