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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective Trial Comparing the Response to Hyperbaric Oxygen Treatment in Patients With Ulcerative and Non-Ulcerative 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 Summary: 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.
Sponsor: Kenneth Peters, MD

Current Primary Outcome: Global Response Assessment (GRA) [ Time Frame: 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.


Original Primary Outcome: Global Response Assessment [ Time Frame: 3 months ]

Patients are asked if since the HBOT their bladder symptoms have been Markedly wose, Moderately worse, Mildly wose, Same, Mildly better, Moderately better, or Markedly better.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: William Beaumont Hospitals

Dates:
Date Received: November 22, 2011
Date Started: March 2011
Date Completion:
Last Updated: January 12, 2017
Last Verified: January 2017