Trial Outcomes & Findings for Prospective Trial Comparing Response to Hyperbaric Oxygen Treatment in Patients With Interstitial Cystitis (NCT NCT01479725)

NCT ID: NCT01479725

Last Updated: 2017-03-03

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 8 participants
• Primary outcome timeframe: 3 months post treatment
• Results posted on: 2017-03-03

Participant Flow

Participant milestones

Measure	Ulcerative IC HBOT for ulcerative IC HBOT: HBOT	Non-Ulcerative IC HBOT for non-ulcerative IC HBOT: HBOT
Overall Study STARTED	6	2
Overall Study COMPLETED	4	1
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prospective Trial Comparing Response to Hyperbaric Oxygen Treatment in Patients With Interstitial Cystitis

Baseline characteristics by cohort

Measure	Ulcerative IC n=6 Participants HBOT for ulcerative IC HBOT: HBOT	Non-Ulcerative IC n=2 Participants HBOT for non-ulcerative IC HBOT: HBOT	Total n=8 Participants Total of all reporting groups
Age, Continuous	54.3 years n=93 Participants	53 years n=4 Participants	54 years n=27 Participants
Gender Female	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants
Gender Male	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	6 participants n=93 Participants	2 participants n=4 Participants	8 participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Ulcerative IC n=6 Participants HBOT for ulcerative IC HBOT: HBOT	Non-Ulcerative IC n=2 Participants HBOT for non-ulcerative IC HBOT: HBOT
Global Response Assessment (GRA) Moderately Better	1 number of participants	0 number of participants
Global Response Assessment (GRA) Mildly Better	4 number of participants	0 number of participants
Global Response Assessment (GRA) Unchanged	0 number of participants	1 number of participants
Global Response Assessment (GRA) Markedly Better	0 number of participants	1 number of participants
Global Response Assessment (GRA) Mildy Worse	0 number of participants	0 number of participants
Global Response Assessment (GRA) Moderately Worse	0 number of participants	0 number of participants
Global Response Assessment (GRA) Markedly Worse	1 number of participants	0 number of participants

Adverse Events

Ulcerative IC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-Ulcerative IC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kenneth Peters

Beaumont Hospital, Royal Oak

Phone: 248-551-0387

Email: Kenneth.Peters@Beaumont.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place