Hyperbaric Oxygen Therapy for Inflammatory Conditions of the Urinary Bladder

NCT03143920 | Terminated Early Phase 1 FDA Drug FDA Device

• 1 other identifier: HBOTurology.2017
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Interstitial Cystitis; Painful Bladder Syndrome; Recurrent Urinary Tract Infection

Keywords

hyperbaric oxygen; inflammation; chronic disease; urinary bladder; urinary tract infection; recurrent urinary tract infection; painful bladder syndrome; chronic pain; hypoxia; bacterial infection

Outcome Measures

Primary Outcomes (2)

• HBOT acceptance

  The primary outcome will be the number of patients that enroll in the study relative to the number offered enrollment and reported as a percentage of total patients offered enrollment.

  Three year study period. Determination is made for this endpoint at time of initiation of HBOT

• HBOT adherence

  The number of individuals completing the prescribed 40 treatment sessions and reported as a percentage of the number of individuals who initially enrolled in the study.

  Three year study period. Determination is made for this endpoint on the date of final HBOT session.

Secondary Outcomes (4)

• Pre and post treatment symptom survey for the chronic interstitial cystitis study group.

  Three year study period. Determination is made for this endpoint on the date prior to first HBOT and final HBOT session and then by telephone followup at 1, 6, and 12 months following the last HBOT session.

• Post treatment incidence of recurrent urinary tract infection.

  Three year study period. Determination of this endpoint will be made for each individual patient at one year after final HBOT session.

• Pre and post treatment symptom survey fro the chronic interstitial cystitis study group. The patient's overall rating of improvement of symptoms (PORIS) will be used.

  Three year study period. Determination is made for this endpoint on the date prior to first HBOT and final HBOT session and then by telephone followup at 1, 6, and 12 months following the last HBOT session.

• Time of occurrence of recurrent urinary tract infection.

  Three year study period. Determination of this endpoint will be made for each individual patient at one year after final HBOT session.

Study Arms (1)

Hyperbaric Oxygen

EXPERIMENTAL

Hyperbaric oxygen therapy-2.4 atmosphere absolute for 90 minutes with 2-five minute air breaks administered daily, 5 days per week for 8 weeks total treatment.

Combination Product: Hyperbaric Oxygen Therapy-

Interventions

Hyperbaric Oxygen Therapy- COMBINATION_PRODUCT

Hyperbaric oxygen therapy provides 100% medical grade oxygen at 2.4 atmospheres of absolute pressure with a Class A multiple person chamber or Class B single person chamber. Hyperbaric chambers are classified as a Class II medical device and have been FDA cleared.

Hyperbaric Oxygen

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Hillcrest Hosptial

San Diego, California, 92103, United States

Location

Related Publications (3)

• Camporesi EM. Side effects of hyperbaric oxygen therapy. Undersea Hyperb Med. 2014 May-Jun;41(3):253-7.

  PMID: 24984321 BACKGROUND

• Propert KJ, Mayer RD, Wang Y, Sant GR, Hanno PM, Peters KM, Kusek JW; Interstitial Cystitis Clinical Trials Group. Responsiveness of symptom scales for interstitial cystitis. Urology. 2006 Jan;67(1):55-9. doi: 10.1016/j.urology.2005.07.014.

  PMID: 16413332 BACKGROUND

• Plafki C, Peters P, Almeling M, Welslau W, Busch R. Complications and side effects of hyperbaric oxygen therapy. Aviat Space Environ Med. 2000 Feb;71(2):119-24.

  PMID: 10685584 RESULT

MeSH Terms

Conditions

Cystitis, Interstitial; Urinary Tract Infections; Inflammation; Chronic Disease; Chronic Pain; Hypoxia; Bacterial Infections

Interventions

Hyperbaric Oxygenation

Condition Hierarchy (Ancestors)

Cystitis; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Respiratory; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Ian R Grover, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective pilot study to test feasibility of treating patients with chronic inflammatory conditions of the urinary bladder with hyperbaric oxygen therapy.

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 8, 2017
• Study Start: November 1, 2017
• Primary Completion: July 7, 2022
• Study Completion: July 7, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)