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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
Sponsor:
Collaborator:
University of Padova
Information provided by (Responsible Party):
Enrico Camporesi, 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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Interstitial Cystitis Device: Intermittent Exposure to Oxygen via Oro-Nasal Mask Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Sponsors and Collaborators
University of South Florida
University of Padova
Investigators
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Study Director: Gerardo Bosco, MD University of Padova

Publications:

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Responsible Party: Enrico Camporesi, Professor of Surgery, University of South Florida
ClinicalTrials.gov Identifier: NCT03693001     History of Changes
Other Study ID Numbers: HEC-DSB 07/16 Padua, It
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We are planning wide distribution of these results among urologists, neurologists, and internal medicine specialists.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 6 months
Access Criteria: upon email request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Cystitis
Cystitis, Interstitial
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases