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

Kenneth Peters, MD

Status and phase

Completed

Phase 2

Conditions

Interstitial Cystitis

Treatments

Procedure: HBOT

Study type

Interventional

Funder types

Other

Identifiers

NCT01479725

2010-247

Details and patient eligibility

About

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.

Full 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.

Enrollment

8 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.