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

Primary Purpose

Interstitial Cystitis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

HBOT

About this trial

This is an interventional treatment trial for Interstitial Cystitis focused on measuring interstitial cystitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Beaumont Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Ulcerative IC

Non-Ulcerative IC

Arm Description

HBOT for ulcerative IC

HBOT for non-ulcerative IC

Outcomes

Primary Outcome Measures

Global Response Assessment (GRA)

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01479725

First Posted

November 22, 2011

Last Updated

January 12, 2017

Sponsor

Kenneth Peters, MD

Collaborators

William Beaumont Hospitals

1. Study Identification

Unique Protocol Identification Number

NCT01479725

Brief Title

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

Official Title

A Prospective Trial Comparing the Response to Hyperbaric Oxygen Treatment in Patients With Ulcerative and Non-Ulcerative Interstitial Cystitis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

August 2012 (Actual)

Study Completion Date

May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Kenneth Peters, MD

Collaborators

William Beaumont Hospitals

4. Oversight

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Interstitial Cystitis

Keywords

interstitial cystitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ulcerative IC

Arm Type

Experimental

Arm Description

HBOT for ulcerative IC

Arm Title

Non-Ulcerative IC

Arm Type

Experimental

Arm Description

HBOT for non-ulcerative IC

Intervention Type

Procedure

Intervention Name(s)

HBOT

Other Intervention Name(s)

hyperbaric oxygen therapy

Intervention Description

HBOT

Primary Outcome Measure Information:

Title

Global Response Assessment (GRA)

Description

Time Frame

3 months post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth Peters, MD

Organizational Affiliation

Beaumont Hospital, Royal Oak

Official's Role

Principal Investigator

Facility Information:

Facility Name

Beaumont Hospital

City

Royal Oak

State/Province

Michigan

ZIP/Postal Code

48073

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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