NCT01479725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 24, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

March 3, 2017

Completed
Last Updated

March 3, 2017

Status Verified

January 1, 2017

Enrollment Period

1.4 years

First QC Date

November 22, 2011

Results QC Date

November 13, 2016

Last Update Submit

January 12, 2017

Conditions

Interstitial Cystitis

Keywords

interstitial cystitis

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months post treatment

Study Arms (2)

Ulcerative IC

EXPERIMENTAL

HBOT for ulcerative IC

Procedure: HBOT

Non-Ulcerative IC

EXPERIMENTAL

HBOT for non-ulcerative IC

Procedure: HBOT

Interventions

HBOTPROCEDURE

HBOT

Also known as: hyperbaric oxygen therapy
Non-Ulcerative ICUlcerative IC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Oxygen Inhalation TherapyRespiratory TherapyTherapeutics

Limitations and Caveats

A small number of patients were enrolled and treated (n=8), with only 5 patients completing the entire study. Three patients withdrew within the year following HBOT and were considered non-responders.

Results Point of Contact

Title
Dr. Kenneth Peters
Organization
Beaumont Hospital, Royal Oak
Kenneth.Peters@Beaumont.edu
248-551-0387

Study Officials

  • Kenneth Peters, MD

    Beaumont Hospital, Royal Oak

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 22, 2011

First Posted

November 24, 2011

Study Start

March 1, 2011

Primary Completion

August 1, 2012

Study Completion

May 1, 2013

Last Updated

March 3, 2017

Results First Posted

March 3, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)