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

University of South Florida

Status: Completed

Conditions: Fibromyalgia; Interstitial Cystitis

Treatments: Device: Intermittent Exposure to Oxygen via Oro-Nasal Mask

Study type: Interventional

Funder types: Other

Identifiers

NCT03693001

HEC-DSB 07/16 Padua, It

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

IC/FM Patients

Experimental group

Description:

All patients had been diagnosed with fibromyalgia and were suffering from IC by standard criteria.

Treatment:

Device: Intermittent Exposure to Oxygen via Oro-Nasal Mask