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

Not Applicable

Completed

• Conditions: Interstitial Cystitis; Fibromyalgia
• Interventions: Device: Intermittent Exposure to Oxygen via Oro-Nasal Mask

• Registration Number: NCT03693001
• Lead Sponsor: University of South Florida

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2018-06-01
• Study Completion: 2018-06-15
• Study First Submitted: 2018-09-28
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-01
• Study First Posted: 2018-10-02
• Last Update Submitted: 2020-12-07
• Last Update Posted: 2020-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IC/FM Patients	Intermittent Exposure to Oxygen via Oro-Nasal Mask	All patients had been diagnosed with fibromyalgia and were suffering from IC by standard criteria.

Primary Outcome Measures

Name	Time	Method
Bladder Capacity	1-3 months after completing procedure	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.
Frequency of Urination	1-3 months after completing procedure	Frequency of Urination was measured via a voiding diary. Patients recorded all urinary events via the voiding diary.
Pain symptoms in IC patients	1-3 months after completing procedure	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).
Pain Symptoms in IC patients	1-3 months after completing procedure	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.
Bladder Capacity (as part of symptoms)	1-3 months after completing procedure	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.