Fibromyalgia, Interstitial Cystitis
Conditions
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.
Interventions
DEVICEIntermittent Exposure to Oxygen via Oro-Nasal Mask
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.
Sponsors
University of Padova
University of South Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Outcome results
None listed