Hyperbaric Oxygen Therapy for Inflammatory Conditions of the Urinary Bladder
TerminatedEarly phase 1NCT03143920
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Pilot study to determine feasibility for treating patients with two chronic inflammatory conditions of the urinary bladder: chronic interstitial cystitis and recurrent urinary tract infections using a standardized hyperbaric oxygen treatment plan. Presently there are no good treatments for these conditions and hyperbaric oxygen may be a safe and readily accessible therapy as it has proven successful an another type of chronic inflammatory condition of the urinary bladder known as "radiation cystitis". The study will determine if patients will consider this an acceptable treatment for their conditions and that it is well tolerated.
Study details
- Official title
- Hyperbaric Oxygen Therapy for Inflammatory Conditions of the Urinary Bladder: A Feasibility Trial
- Conditions
- Chronic Interstitial Cystitis
- Painful Bladder Syndrome
- Recurrent Urinary Tract Infection
- Interventions
- Combination product: Hyperbaric Oxygen Therapy-
- Sponsor
- University of California, San Diego
- Start date
- 2017-11-01
- Primary completion
- 2022-07-07
- Sex
- Female
- Age range
- from 35 Years to 70 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * CIC/PBS- patients with urinary tract pain or discomfort and dysuria that is present for \> 6 months and is not due to acute urinary tract infection, stones or other urinary pathology. * rUTI- patients with greater that 2 urinary tract infections in 6 months or greater than 3 urinary tract infections in one year. A UTI is defined as - symptomatic complaints of dysuria, increased frequency of urination, and hesitancy to urinate and a clean catch urinary culture with \>103 colony counts of bacteria per milliliter. Exclusion Criteria: * Inability to provide written informed consent * Inability or unwillingness to adhere to 40 HBOT treatment sessions over an 8-10 week time period or to complete follow up questionnaires/telephone contacts. * Confinement anxiety and inability to enter the hyperbaric chamber for a 90 minutes treatment session. * Inability to effectively equalize the middle ear during changes in ambient pressure. This will include patients with a history of tympanic membrane perforation, head and neck surgery with compromised Eustachian tube function, including but not limited to tracheostomy, mastoidectomy, middle ear surgical procedures and cochlear implants. * Presence of an indwelling urinary catheter * Any acute or chronic urinary condition that is not rUTI or CIC/PBS- such as but not limited to urinary bladder stones, tumors, urinary retention, adynamic urinary bladder, chemotherapy related hemorrhagic cystitis, radiation cystitis or other pathology. * Active or uncontrolled cancer diagnosis. * Active or uncontrolled psychiatric disease. * American Heart Association Class III or greater congestive heart failure or symptomatic coronary artery disease. * Active or uncontrolled pulmonary diseases- including asthma, COPD, bullous lung disease, previous thoracotomy, pneumothorax or history of pneumothorax. * Acute upper respiratory tract infection. * End stage renal disease receiving hemo- or peritoneal dialysis * Active or history of seizure disorder * Hemolytic blood dyscrasias * History of exposure to bleomycin * Presence of a pacemaker or epidural pain pump * Pregnant or lactating women * Patients with type 2 diabetes * Patients with neurovascular diseases (e.g. recent stroke) * Patients with uncontrolled hypertension * Patients with retinitis pigmentosa * Patients taking the following concomitant medications: PDE5 inhibitors, carbonic anhydrase inhibitors, beta blockers, alpha blockers, nitrates.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03143920