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| Name | Class |
|---|---|
| Corewell Health East | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulcerative IC | Experimental | HBOT for ulcerative IC |
|
| Non-Ulcerative IC | Experimental | HBOT for non-ulcerative IC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBOT | Procedure | HBOT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Peters, MD | Beaumont Hospital, Royal Oak | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ulcerative IC | HBOT for ulcerative IC HBOT: HBOT |
| FG001 | Non-Ulcerative IC | HBOT for non-ulcerative IC HBOT: HBOT |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ulcerative IC | HBOT for ulcerative IC HBOT: HBOT |
| BG001 | Non-Ulcerative IC | HBOT for non-ulcerative IC HBOT: HBOT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | number of participants | 3 months post treatment |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ulcerative IC | HBOT for ulcerative IC HBOT: HBOT |
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A small number of patients were enrolled and treated (n=8), with only 5 patients completing the entire study. Three patients withdrew within the year following HBOT and were considered non-responders.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kenneth Peters | Beaumont Hospital, Royal Oak | 248-551-0387 | Kenneth.Peters@Beaumont.edu |
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| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Non-Ulcerative IC | HBOT for non-ulcerative IC HBOT: HBOT | 0 | 2 | 0 | 2 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |