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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01479725
First Posted: November 24, 2011
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
William Beaumont Hospitals
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals
Results First Submitted: November 13, 2016  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ulcerative IC

HBOT for ulcerative IC

HBOT: HBOT

Non-Ulcerative IC

HBOT for non-ulcerative IC

HBOT: HBOT


Participant Flow:   Overall Study
    Ulcerative IC   Non-Ulcerative IC
STARTED   6   2 
COMPLETED   4   1 
NOT COMPLETED   2   1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ulcerative IC

HBOT for ulcerative IC

HBOT: HBOT

Non-Ulcerative IC

HBOT for non-ulcerative IC

HBOT: HBOT

Total Total of all reporting groups

Baseline Measures
   Ulcerative IC   Non-Ulcerative IC   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   2   8 
Age 
[Units: Years]
Mean (Full Range)
 54.3 
 (35 to 66) 
 53 
 (51 to 55) 
 54 
 (35 to 66) 
Gender 
[Units: Participants]
Count of Participants
     
Female      4  66.7%      2 100.0%      6  75.0% 
Male      2  33.3%      0   0.0%      2  25.0% 
Region of Enrollment 
[Units: Participants]
     
United States   6   2   8 


  Outcome Measures

1.  Primary:   Global Response Assessment (GRA)   [ Time Frame: 3 months post treatment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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
e-mail: Kenneth.Peters@Beaumont.edu



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
Last Update Posted: March 3, 2017