HBOT for Patients With IC/FM (Interstitial Cystitis/Fibromyalgia)

Study Overview
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Brief Summary
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The investigators observed 12 fibromyalgia and interstitial cystitis patients undergoing hyperbaric oxygen oxygen treatment in a multiplace pressure chamber for 90 minutes, 40 treatment each, using an oro-nasal mask.

Detailed Description
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The investigators structured a prospective observational pilot experimental design in consenting patients with IC and FM, with repeated subjective and urological measures conducted before and after a therapeutic protocol. The study duration was set to 3 months. Patients were exposed to breathing 100% oxygen at 2 atmospheres absolute (ATA) in a multiplace pressure chamber for 90 minutes using an oro-nasal mask. Patients undertook a cycle of 20 sessions for 5 days per week for four weeks. After one week of suspension, a second cycle of 20 sessions was completed.

Official Title
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Clinical and Morphological Effects of Hyperbaric Oxygen Therapy in Patients With Interstitial Cystitis Associated With Fibromyalgia

Conditions
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Fibromyalgia, Interstitial Cystitis

Intervention / Treatment
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* Device: Intermittent Exposure to Oxygen via Oro-Nasal Mask


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of absence of Hunner's ulcers Pain in bladder that improves with urination pain(supra-pubic, pelvic, urethral, vaginal, or perineal) presence of glomerulation or bleeding +/- at the cystodistension reduced capacity increased proprioceptive sensitivity normal or reduced compliance number of tender points that establish that diagnosis Exclusion Criteria: Pregnancy (diagnosed or within a year) age less than 18 years benign or malignant bladder tumors radiation cystitis symptomatic bladder diversions herpes in active phase bladder and urethral stones urinary frequency less than 10 times a day presence of symptoms less than 12 months bladder capacity>400ml with no sensitive urgency

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IC/FM Patients<br>All patients had been diagnosed with fibromyalgia and were suffering from IC by standard criteria. | Device: Intermittent Exposure to Oxygen via Oro-Nasal Mask<br>* Patients were exposed to breathing 100% oxygen at 2 atmospheres absolute (ATA) in a multiplace pressure chamber for 90 minutes using an oro-nasal mask for 40 treatments over a 2 month period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Urination | Frequency of Urination was measured via a voiding diary. Patients recorded all urinary events via the voiding diary. | 1-3 months after completing procedure | 
| Pain symptoms in IC patients | Widespread Pain Index (WPI): total amount ranges from 0 to 19 points corresponding to the possibly-painful 19 body areas (i.e., areas of the shoulders, arms, hips, legs, jaws, chest, abdomen, back, and neck). | 1-3 months after completing procedure | 
| Pain Symptoms in IC patients | Pelvic Pain & Urgency and Frequency Symptom Scale (PUF: Total scores range from 0-35 (symptom subscale 0-23 and bother subscale 0-12). The higher the scores, the more severe the level of symptoms. | 1-3 months after completing procedure | 
| Bladder Capacity (as part of symptoms) | Symptom Severity Scale (SSS): symptoms are measured on the basis of a 0-3 severity scale considering fatigue, waking unrefreshed, and cognitive symptoms. The greater the amount, the more severe the symptomatology. | 1-3 months after completing procedure | 
| Bladder Capacity | O'Leary Saint Index: measures the symptoms of the lower urinary tract and their influence on quality-of-life in subjects with IC. Scales range from 0-5 in most cases, with 0 being indicative of little to no symptoms and higher numbers indicative of more severe symptomatology. | 1-3 months after completing procedure |