Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT03143920
Eligibility 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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
70 Years
Study:
NCT03143920
Study Brief:
Protocol Section:
NCT03143920