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Completed

NCT Number: NCT03693001

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

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.

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Key information

Conditions

Fibromyalgia Cystitis Cystitis, Interstitial Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Interstitial Cystitis Male Urogenital Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent Exposure to Oxygen via Oro-Nasal Mask

Device

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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • University of Padova

Registry information

Official study title

Clinical and Morphological Effects of Hyperbaric Oxygen Therapy in Patients With Interstitial Cystitis Associated With Fibromyalgia

Acronym: IC/FMHBOT

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 2, 2018
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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