This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback
Trial record 9 of 136 for:    Cystitis, Interstitial

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

This study has been completed.
William Beaumont Hospitals
Information provided by (Responsible Party):
Kenneth Peters, MD, William Beaumont Hospitals Identifier:
First received: November 22, 2011
Last updated: January 12, 2017
Last verified: January 2017
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
Other Name: hyperbaric oxygen therapy
Experimental: Non-Ulcerative IC
HBOT for non-ulcerative IC
Procedure: 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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01479725

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

Responsible Party: Kenneth Peters, MD, Principal Investigator, William Beaumont Hospitals Identifier: NCT01479725     History of Changes
Other Study ID Numbers: 2010-247
Study First Received: November 22, 2011
Results First Received: November 13, 2016
Last Updated: January 12, 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, Interstitial
Urinary Bladder Diseases
Urologic Diseases processed this record on September 20, 2017