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

Phase 2

Completed

• Conditions: Interstitial Cystitis
• Interventions: Procedure: HBOT

• Registration Number: NCT01479725
• Lead Sponsor: Kenneth Peters, MD

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-11-22
• Study First Submitted QC: 2011-11-23
• Study First Posted: 2011-11-24
• Primary Completion: 2012-08
• Study Completion: 2013-05
• Results First Submitted: 2016-11-13
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-12
• Last Update Submitted: 2017-01-12
• Results First Posted: 2017-03-03
• Last Update Posted: 2017-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ulcerative IC	HBOT	HBOT for ulcerative IC
Non-Ulcerative IC	HBOT	HBOT for non-ulcerative IC

Primary Outcome Measures

Name	Time	Method
Global Response Assessment (GRA)	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.

Trial Locations

Locations (1)

Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States