HBOT for Patients With IC/FM (Interstitial Cystitis/Fibromyalgia) (IC/FMHBOT)
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|ClinicalTrials.gov Identifier: NCT03693001|
Recruitment Status : Completed
First Posted : October 2, 2018
Last Update Posted : October 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia Interstitial Cystitis||Device: Intermittent Exposure to Oxygen via Oro-Nasal Mask||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical and Morphological Effects of Hyperbaric Oxygen Therapy in Patients With Interstitial Cystitis Associated With Fibromyalgia|
|Actual Study Start Date :||June 1, 2016|
|Actual Primary Completion Date :||June 1, 2018|
|Actual Study Completion Date :||June 15, 2018|
Experimental: IC/FM Patients
All patients had been diagnosed with fibromyalgia and were suffering from IC by standard criteria.
Device: Intermittent 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.
- Frequency of Urination [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693001
|Study Director:||Gerardo Bosco, MD||University of Padova|