Hyperbaric Oxygen Therapy for Inflammatory Conditions of the Urinary Bladder

  • STATUS
    Recruiting
  • End date
    Oct 30, 2022
  • participants needed
    40
  • sponsor
    University of California, San Diego
Updated on 11 May 2021
urinary tract infection
discomfort
hyperbaric oxygen
cystitis
chronic interstitial cystitis

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.

Description

The primary object is to determine the feasibility of treating patients diagnosed with either CIC/PBS or rUTI with daily hyperbaric oxygen for a total of 40 treatment sessions during an 8-10 week time period. We wish to better understand the demand and degree of adherence for daily HBOT in these two patient populations to inform future planning and design of randomized, sham controlled and double-blind studies. Given the refractory nature of these two diagnoses, a secondary objective of this study is to determine if there is symptomatic improvement following HBOT compared to pretreatment symptoms using standardized patient symptomology questionnaires' (Global Response Assessment-GRA and Patient's Overall Rating of Improvement in Symptoms-PORIS questionnaires).

Patient selection will be carried out by the respective co-investigators based on standard disease definitions. CIC/PBS is defined as urinary tract pain or discomfort and dysuria that is present of > 6 months and is not due to acute urinary tract infection, stones or other pathology. These patients will be identified and recruited by Dr. C. Lowell Parsons, Co-investigator for the study. rUTI is defined as greater than 2 urinary tract infections in 6 month or greater than 3 urinary tract infections in one year. These patient will be identified and recruited by Dr. Emily Lukacz, Co-investigator. Each study will enroll 20 individuals. The study design is an observational pilot study to determine feasibility and limited efficacy. Thus the primary outcomes will be the number of patients that enroll in the study relative to the number offered enrollment and the percentage of individuals completing the prescribed 40 treatment sessions. For the secondary outcome, limited efficacy, each patient's pre-treatment clinical status will be compared to their post treatment clinical status. Thus for the CIC/PBS study both the global response assessment (GRA) and the patient's overall rating of improvement of symptoms (PORIS) will be obtained and comparison between the pre and post treatment scores will be performed. For the UTI study, the time in days to subsequent acute urinary tract infection and total number of acute UTI's during one year following completion of HBOT will be recorded and compared to that individual's prior clinical history. The dosing algorithm to be used is based on the current standard of care for the treatment of radiation cystitis for which 2.4 ATA x 90 minutes is provided daily, 5 days per week. The total duration of treatment can range from 30-60 minutes depending upon the individual patients severity of illness and response to therapy. Patients are routinely reassessed after every 10-20 treatments. Therefore we are planning to provide 2.4 ATA x 90 minutes with 2 air breaks daily, x 5 days per week x 8 weeks total for both CIC/PBS and rUTI patient population. We will allow the 40 treatments to be administered over an 8-10 week time period to provide some degree of scheduling flexibility for patients.

For this feasibility study we will determine the demand as measured by the number of patients accepting the treatment vs the total number of patients offered enrollment. We will determine the percentage successful completion of the 40 prescribed treatment sessions as the primary outcome variable. The results of the symptom questionnaires obtained at the conclusion for HBOT and by follow up telephone survey at 1, 6 and 12 months following completion of HBOT will be the secondary outcome variable. Finally, adverse events will be gathered on this patient population as per routine clinical practice. The incidence and severity of otic barotrauma, hyperoxic myopia, confinement anxiety and generalized seizures will be determined and compared to the same events experienced by the general hyperbaric patient population being treated during the same period of time.

Symptom Survey Instruments Global Response Assessment (GRA) 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.

Patient's Overall Rating of Improvement of Symptoms (PORIS) 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.

Details
Condition Interstitial Cystitis, Bladder Pain Syndrome, Recurrent Urinary Tract Infection, Recurrent Urinary Tract Infections, chronic interstitial cystitis, painful bladder syndrome, recurrent utis
Treatment Hyperbaric Oxygen Therapy-
Clinical Study IdentifierNCT03143920
SponsorUniversity of California, San Diego
Last Modified on11 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 35 yrs and 70 yrs?
Are you female?
Do you have any of these conditions: Recurrent Urinary Tract Infection or Interstitial Cystitis?
Do you have any of these conditions: Interstitial Cystitis or recurrent utis or Bladder Pain Syndrome or painful bladder syndrome or chronic interstitial cystitis or Recurrent Urinary Tra...?
Do you have any of these conditions: Recurrent Urinary Tract Infection or chronic interstitial cystitis or Recurrent Urinary Tract Infections or Bladder Pain Syndrome or recurrent utis or...?
Do you have any of these conditions: painful bladder syndrome or chronic interstitial cystitis or recurrent utis or Bladder Pain Syndrome or Interstitial Cystitis or Recurrent Urinary Tra...?
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
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