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

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ClinicalTrials.gov Identifier: NCT01479725
Recruitment Status : Completed
First Posted : November 24, 2011
Results First Posted : March 3, 2017
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Interstitial Cystitis
Intervention Procedure: HBOT
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ulcerative IC Non-Ulcerative IC
Hide Arm/Group Description

HBOT for ulcerative IC

HBOT: HBOT

HBOT for non-ulcerative IC

HBOT: HBOT

Period Title: Overall Study
Started 6 2
Completed 4 1
Not Completed 2 1
Arm/Group Title Ulcerative IC Non-Ulcerative IC Total
Hide Arm/Group Description

HBOT for ulcerative IC

HBOT: HBOT

HBOT for non-ulcerative IC

HBOT: HBOT

Total of all reporting groups
Overall Number of Baseline Participants 6 2 8
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 2 participants 8 participants
54.3
(35 to 66)
53
(51 to 55)
54
(35 to 66)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 2 participants 8 participants
Female
4
  66.7%
2
 100.0%
6
  75.0%
Male
2
  33.3%
0
   0.0%
2
  25.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 2 participants 8 participants
6 2 8
1.Primary Outcome
Title Global Response Assessment (GRA)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ulcerative IC Non-Ulcerative IC
Hide Arm/Group Description:

HBOT for ulcerative IC

HBOT: HBOT

HBOT for non-ulcerative IC

HBOT: HBOT

Overall Number of Participants Analyzed 6 2
Measure Type: Number
Unit of Measure: number of participants
Markedly Better 0 1
Moderately Better 1 0
Mildly Better 4 0
Unchanged 0 1
Mildy Worse 0 0
Moderately Worse 0 0
Markedly Worse 1 0
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ulcerative IC Non-Ulcerative IC
Hide Arm/Group Description

HBOT for ulcerative IC

HBOT: HBOT

HBOT for non-ulcerative IC

HBOT: HBOT

All-Cause Mortality
Ulcerative IC Non-Ulcerative IC
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ulcerative IC Non-Ulcerative IC
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/2 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ulcerative IC Non-Ulcerative IC
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/2 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Kenneth Peters
Organization: Beaumont Hospital, Royal Oak
Phone: 248-551-0387
Responsible Party: Kenneth Peters, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT01479725     History of Changes
Other Study ID Numbers: 2010-247
First Submitted: November 22, 2011
First Posted: November 24, 2011
Results First Submitted: November 13, 2016
Results First Posted: March 3, 2017
Last Update Posted: March 3, 2017