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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
November 22, 2011
November 24, 2011
November 13, 2016
 
March 3, 2017
March 2011
August 2012   (Final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01479725 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Prospective Trial Comparing Response to Hyperbaric Oxygen Treatment in Patients With Interstitial Cystitis
A Prospective Trial Comparing the Response to Hyperbaric Oxygen Treatment in Patients With Ulcerative and Non-Ulcerative Interstitial Cystitis
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.
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Interstitial Cystitis
Procedure: HBOT
HBOT
Other Name: hyperbaric oxygen therapy
  • Experimental: Ulcerative IC
    HBOT for ulcerative IC
    Intervention: Procedure: HBOT
  • Experimental: Non-Ulcerative IC
    HBOT for non-ulcerative IC
    Intervention: Procedure: HBOT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
May 2013
August 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Interstitial cystitis.
  • Urinary frequency of at least 8 times per 24 hours period.
  • Patients with ulcerative IC must have undergone previous biopsy negative for cancer.
  • Patients must agree to not begin any additional treatment for IC until study completion.

Exclusion Criteria:

  • Absolute or relative contraindication to hyperbaric oxygen treatment.
  • Patients dependent on intermittent catheterization or indwelling catheter to empty bladder.
  • Any imminent change in residence, which could compromise compliance.
  • Unlikely to be compliant due to unmanaged medical or psychological problems.
  • Severe debilitating concurrent medical conditions.
  • A history of pelvic radiation, bladder stone, bladder cancer or cancer in situ, or urethral cancer.
  • Precious bladder or neurologic surgery which has affected bladder function.
  • Currently has an active urethral stone, ureteral stone or urethral diverticulum.
  • Subject misses more than 10 treatments.
  • Severe claustrophobia.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01479725
2010-247
No
Not Provided
Plan to Share IPD: No
Kenneth Peters, MD, William Beaumont Hospitals
Kenneth Peters, MD
William Beaumont Hospitals
Principal Investigator: Kenneth Peters, MD Beaumont Hospital, Royal Oak
William Beaumont Hospitals
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP