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Hyperbaric Oxygen Therapy for Inflammatory Conditions of the Urinary Bladder (HBOTCICrUTI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03143920
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ian Grover, MD, University of California, San Diego

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.

Condition or disease Intervention/treatment Phase
Chronic Interstitial Cystitis Painful Bladder Syndrome Recurrent Urinary Tract Infection Combination Product: Hyperbaric Oxygen Therapy- Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective pilot study to test feasibility of treating patients with chronic inflammatory conditions of the urinary bladder with hyperbaric oxygen therapy.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hyperbaric Oxygen Therapy for Inflammatory Conditions of the Urinary Bladder: A Feasibility Trial
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hyperbaric Oxygen
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-
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.




Primary Outcome Measures :
  1. HBOT acceptance [ Time Frame: Three year study period. Determination is made for this endpoint at time of initiation of HBOT ]
    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.

  2. HBOT adherence [ Time Frame: Three year study period. Determination is made for this endpoint on the date of final HBOT session. ]
    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.


Secondary Outcome Measures :
  1. Pre and post treatment symptom survey for the chronic interstitial cystitis study group. [ Time Frame: 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. ]
    The global response assessment (GRA)will be obtained and comparison between the pre and post treatment scores will be performed. The GRA measures overall improvement with therapy. It is now used as the primary end point in clinical trials of therapies for CIC/PBS. The assessment asks: "As compared to when you started the study [treatment], how would you rate your interstitial cystitis symptoms now?" The seven point scale is centered at zero (no change): markedly worse; moderately worse; slightly worse; no change; slightly improved; moderately improved; and markedly improved. Responders will be defined as those individuals with scores falling in the moderately and markedly improved categories. The number of responders will be reported as a percentage of total number of individuals completing 40 HBOT sessions.

  2. Post treatment incidence of recurrent urinary tract infection. [ Time Frame: Three year study period. Determination of this endpoint will be made for each individual patient at one year after final HBOT session. ]
    The number of patients who develop recurrent urinary tract infections relative to the total number of patients receiving HBOT and reported as a percentage.

  3. 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. [ Time Frame: 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. ]
    The PORIS has three questions that address the overall change in CIC/PBS, pain, and urgency after treatment as worse, no better (0% improvement), slightly improved (25%), moderately improved (50%), greatly improved (75%), or symptoms gone (100% improvement). Responders will be defined as those individuals with scores falling into the moderately or greatly improved or no symptoms categories. The number of responders will be reported as a percentage of total number of individuals completing 40 HBOT sessions.

  4. Time of occurrence of recurrent urinary tract infection. [ Time Frame: Three year study period. Determination of this endpoint will be made for each individual patient at one year after final HBOT session. ]
    The time in days at which a recurrent urinary tract infection is occurs will be recorded from the date following final HBOT session and reported as a mean with standard deviation.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143920


Contacts
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Contact: Ian R Grover, MD 619-543-6218 igrover@ucsd.edu
Contact: Maegan Carey 619-543-7342 mcarey@ucsd.edu

Locations
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United States, California
Hillcrest Hosptial Recruiting
San Diego, California, United States, 92103
Contact: Ian R Grover, MD    619-543-6218    igrover@ucsd.edu   
Contact: Maegan Carey    619-543-7051    mcarey@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Ian R Grover, MD University of California, San Diego

Publications of Results:
Other Publications:
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Responsible Party: Ian Grover, MD, Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03143920    
Other Study ID Numbers: HBOTurology.2017
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual patient data will not be shared. Summarized/group data will be shared between sponsor-investigator and Co-PI's at conclusion of patient enrollment. Data will be obtained by prospective collection and analysis.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Ian Grover, MD, University of California, San Diego:
hyperbaric oxygen
inflammation
chronic disease
urinary bladder
urinary tract infection
recurrent urinary tract infection
painful bladder syndrome
chronic pain
hypoxia
bacterial infection
Additional relevant MeSH terms:
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Infection
Urinary Tract Infections
Cystitis
Cystitis, Interstitial
Urologic Diseases
Urinary Bladder Diseases