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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
  Purpose
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.

Condition Intervention Phase
Interstitial Cystitis Procedure: HBOT Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Trial Comparing the Response to Hyperbaric Oxygen Treatment in Patients With Ulcerative and Non-Ulcerative Interstitial Cystitis

Resource links provided by NLM:


Further study details as provided by Kenneth Peters, MD, William Beaumont Hospitals:

Primary Outcome Measures:
  • 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.


Enrollment: 8
Study Start Date: March 2011
Study Completion Date: May 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ulcerative IC
HBOT for ulcerative IC
Procedure: HBOT
HBOT
Other Name: hyperbaric oxygen therapy
Experimental: Non-Ulcerative IC
HBOT for non-ulcerative IC
Procedure: HBOT
HBOT
Other Name: hyperbaric oxygen therapy

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479725


Locations
United States, Michigan
Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Kenneth Peters, MD
William Beaumont Hospitals
Investigators
Principal Investigator: Kenneth Peters, MD Beaumont Hospital, Royal Oak
  More Information

Responsible Party: Kenneth Peters, MD, Principal Investigator, 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
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Kenneth Peters, MD, William Beaumont Hospitals:
interstitial cystitis

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases