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Completed

NCT Number: NCT01479725

Prospective Trial Comparing Response to Hyperbaric Oxygen Treatment in Patients With 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.

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Key information

Conditions

Interstitial Cystitis Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HBOT

Procedure

HBOT

Other names: hyperbaric oxygen therapy

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Kenneth Peters, MD

Other

Collaborators

  • Corewell Health East

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Nov 24, 2011
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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