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

January 12, 2017 updated by: Kenneth Peters, MD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ulcerative IC
HBOT for ulcerative IC
Procedure: HBOT
HBOT
Other Names:
  • hyperbaric oxygen therapy
EXPERIMENTAL: Non-Ulcerative IC
HBOT for non-ulcerative IC
Procedure: HBOT
HBOT
Other Names:
  • hyperbaric oxygen therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kenneth Peters, MD

Collaborators

William Beaumont Hospitals

Investigators

  • Principal Investigator: Kenneth Peters, MD, Beaumont Hospital, Royal Oak

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

August 1, 2012

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

November 22, 2011

First Submitted That Met QC Criteria

November 23, 2011

First Posted (ESTIMATE)

November 24, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010-247

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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