FibromyalgiaIC/FMHBOTNCT03693001

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

A study testing Intermittent Exposure to Oxygen via Oro-Nasal Mask in people with Fibromyalgia and Interstitial Cystitis, run by University of South Florida.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Fibromyalgia, Interstitial Cystitis
What is being tested?: Intermittent Exposure to Oxygen via Oro-Nasal Mask
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: No sites listed yet
Study dates: 1 Jun 2016to 15 Jun 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

About this study

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

Read the 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.

Conditions: Fibromyalgia, Interstitial Cystitis
Being tested: Intermittent Exposure to Oxygen via Oro-Nasal Mask
Medical subject headings: Fibromyalgia, Cystitis, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intermittent Exposure to Oxygen via Oro-Nasal MaskDevice
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.

Study groups in NCT03693001
Study group	Role	What they receive
IC/FM Patients	Experimental	All patients had been diagnosed with fibromyalgia and were suffering from IC by standard criteria. Receives: Device: Intermittent Exposure to Oxygen via Oro-Nasal Mask

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of Urination
Frequency of Urination was measured via a voiding diary. Patients recorded all urinary events via the voiding diary.
Measured: 1-3 months after completing procedure
Pain symptoms in IC patients
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).
Measured: 1-3 months after completing procedure
Pain Symptoms in IC patients
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.
Measured: 1-3 months after completing procedure
Bladder Capacity (as part of symptoms)
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.
Measured: 1-3 months after completing procedure
Bladder Capacity
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.
Measured: 1-3 months after completing procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201615 Jun 2018

First posted2 Oct 2018
Study start1 Jun 2016
Primary completion1 Jun 2018
Study completion15 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
More trials run by University of South FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03693001
Sponsor's protocol ID: HEC-DSB 07/16 Padua, It
Acronym: IC/FMHBOT
Status last verified: Oct 2018
First submitted: 28 Sep 2018
Last updated: 9 Dec 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: We are planning wide distribution of these results among urologists, neurologists, and internal medicine specialists.

Publications

Parsons CL, Dell J, Stanford EJ, Bullen M, Kahn BS, Waxell T, Koziol JA. Increased prevalence of interstitial cystitis: previously unrecognized urologic and gynecologic cases identified using a new symptom questionnaire and intravesical potassium sensitivity. Urology. 2002 Oct;60(4):573-8. doi: 10.1016/s0090-4295(02)01829-0.
PubMed 12385909
Tanaka T, Nitta Y, Morimoto K, Nishikawa N, Nishihara C, Tamada S, Kawashima H, Nakatani T. Hyperbaric oxygen therapy for painful bladder syndrome/interstitial cystitis resistant to conventional treatments: long-term results of a case series in Japan. BMC Urol. 2011 May 24;11:11. doi: 10.1186/1471-2490-11-11.
PubMed 21609485
van Ophoven A, Rossbach G, Oberpenning F, Hertle L. Hyperbaric oxygen for the treatment of interstitial cystitis: long-term results of a prospective pilot study. Eur Urol. 2004 Jul;46(1):108-13. doi: 10.1016/j.eururo.2004.03.002.
PubMed 15183555
Lee JD, Lee MH. Increased expression of hypoxia-inducible factor-1alpha and vascular endothelial growth factor associated with glomerulation formation in patients with interstitial cystitis. Urology. 2011 Oct;78(4):971.e11-5. doi: 10.1016/j.urology.2011.05.050. Epub 2011 Aug 2.
PubMed 21813166
Loran OB, Siniakova LA, Seregin AV, Mitrokhin AA, Plesovskii AM, Vinarova NA. [Hyperbaric oxygenation in the treatment of patients with interstitial cystitis: clinical and morphological rationale]. Urologiia. 2011 May-Jun;(3):3-5. Russian.
PubMed 21874665
Mathers MJ, Lazica DA, Roth S. [Non-bacterial cystitis: principles, diagnostics and etiogenic therapy options]. Aktuelle Urol. 2010 Nov;41(6):361-8. doi: 10.1055/s-0030-1262615. Epub 2010 Nov 16. German.
PubMed 21082515
Nickel JC, Tripp DA, Pontari M, Moldwin R, Mayer R, Carr LK, Doggweiler R, Yang CC, Mishra N, Nordling J. Interstitial cystitis/painful bladder syndrome and associated medical conditions with an emphasis on irritable bowel syndrome, fibromyalgia and chronic fatigue syndrome. J Urol. 2010 Oct;184(4):1358-63. doi: 10.1016/j.juro.2010.06.005. Epub 2010 Aug 17.
PubMed 20719340
Efrati S, Golan H, Bechor Y, Faran Y, Daphna-Tekoah S, Sekler G, Fishlev G, Ablin JN, Bergan J, Volkov O, Friedman M, Ben-Jacob E, Buskila D. Hyperbaric oxygen therapy can diminish fibromyalgia syndrome--prospective clinical trial. PLoS One. 2015 May 26;10(5):e0127012. doi: 10.1371/journal.pone.0127012. eCollection 2015.
PubMed 26010952
Arnold LM, Clauw DJ, McCarberg BH; FibroCollaborative. Improving the recognition and diagnosis of fibromyalgia. Mayo Clin Proc. 2011 May;86(5):457-64. doi: 10.4065/mcp.2010.0738.
PubMed 21531887
Yildiz S, Kiralp MZ, Akin A, Keskin I, Ay H, Dursun H, Cimsit M. A new treatment modality for fibromyalgia syndrome: hyperbaric oxygen therapy. J Int Med Res. 2004 May-Jun;32(3):263-7. doi: 10.1177/147323000403200305.
PubMed 15174219
van de Merwe JP, Nordling J, Bouchelouche P, Bouchelouche K, Cervigni M, Daha LK, Elneil S, Fall M, Hohlbrugger G, Irwin P, Mortensen S, van Ophoven A, Osborne JL, Peeker R, Richter B, Riedl C, Sairanen J, Tinzl M, Wyndaele JJ. Diagnostic criteria, classification, and nomenclature for painful bladder syndrome/interstitial cystitis: an ESSIC proposal. Eur Urol. 2008 Jan;53(1):60-7. doi: 10.1016/j.eururo.2007.09.019. Epub 2007 Sep 20.
PubMed 17900797
Brewer ME, White WM, Klein FA, Klein LM, Waters WB. Validity of Pelvic Pain, Urgency, and Frequency questionnaire in patients with interstitial cystitis/painful bladder syndrome. Urology. 2007 Oct;70(4):646-9. doi: 10.1016/j.urology.2007.06.1089. Epub 2007 Aug 20.
PubMed 17707887
Jones KD, Maxwell C, Mist SD, King V, Denman MA, Gregory WT. Pelvic Floor and Urinary Distress in Women with Fibromyalgia. Pain Manag Nurs. 2015 Dec;16(6):834-40. doi: 10.1016/j.pmn.2015.06.001. Epub 2015 Aug 8.
PubMed 26259883
Lubeck DP, Whitmore K, Sant GR, Alvarez-Horine S, Lai C. Psychometric validation of the O'leary-Sant interstitial cystitis symptom index in a clinical trial of pentosan polysulfate sodium. Urology. 2001 Jun;57(6 Suppl 1):62-6. doi: 10.1016/s0090-4295(01)01126-8.
PubMed 11378052
Ito T, Tomoe H, Ueda T, Yoshimura N, Sant G, Hanno P. Clinical symptoms scale for interstitial cystitis for diagnosis and for following the course of the disease. Int J Urol. 2003 Oct;10 Suppl:S24-6. doi: 10.1046/j.1442-2042.10.s1.7.x. No abstract available.
PubMed 14641410

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome

All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical and Morphological Effects of Hyperbaric Oxygen Therapy in Patients With Interstitial Cystitis Associated With Fibromyalgia
ClinicalTrials.gov ID: NCT03693001
Acronym / sponsor ID: IC/FMHBOT / HEC-DSB 07/16 Padua, It
Conditions: Fibromyalgia, Interstitial Cystitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: University of South FloridaUniversity, hospital or other
Collaborators: University of Padova
Study start: 1 Jun 2016 (actual)
Primary completion: 1 Jun 2018 (actual)
Study completion: 15 Jun 2018 (actual)
First posted: 2 Oct 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
IC/FM Patients	Experimental	Device: Intermittent Exposure to Oxygen via Oro-Nasal MaskAll patients had been diagnosed with fibromyalgia and were suffering from IC by standard criteria.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (10 listed)

Pregnancy (diagnosed or within a year)
age less than 18 years
benign or malignant bladder tumors
radiation cystitis
symptomatic bladder diversions

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intermittent Exposure to Oxygen via Oro-Nasal MaskPatients 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.	Device	IC/FM Patients

Primary outcome

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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
Background: PubMed 12385909Parsons CL, Dell J, Stanford EJ, Bullen M, Kahn BS, Waxell T, Koziol JA. Increased prevalence of interstitial cystitis: previously unrecognized urologic and gynecologic cases identified using a new symptom questionnaire and intravesical potassium sensitivity. Urology. 2002 Oct;60(4):573-8. doi: 10.1016/s0090-4295(02)01829-0.
Background: PubMed 21609485Tanaka T, Nitta Y, Morimoto K, Nishikawa N, Nishihara C, Tamada S, Kawashima H, Nakatani T. Hyperbaric oxygen therapy for painful bladder syndrome/interstitial cystitis resistant to conventional treatments: long-term results of a case series in Japan. BMC Urol. 2011 May 24;11:11. doi: 10.1186/1471-2490-11-11.
Background: PubMed 15183555van Ophoven A, Rossbach G, Oberpenning F, Hertle L. Hyperbaric oxygen for the treatment of interstitial cystitis: long-term results of a prospective pilot study. Eur Urol. 2004 Jul;46(1):108-13. doi: 10.1016/j.eururo.2004.03.002.
Background: PubMed 21813166Lee JD, Lee MH. Increased expression of hypoxia-inducible factor-1alpha and vascular endothelial growth factor associated with glomerulation formation in patients with interstitial cystitis. Urology. 2011 Oct;78(4):971.e11-5. doi: 10.1016/j.urology.2011.05.050. Epub 2011 Aug 2.
Background: PubMed 21874665Loran OB, Siniakova LA, Seregin AV, Mitrokhin AA, Plesovskii AM, Vinarova NA. [Hyperbaric oxygenation in the treatment of patients with interstitial cystitis: clinical and morphological rationale]. Urologiia. 2011 May-Jun;(3):3-5. Russian.
Background: PubMed 21082515Mathers MJ, Lazica DA, Roth S. [Non-bacterial cystitis: principles, diagnostics and etiogenic therapy options]. Aktuelle Urol. 2010 Nov;41(6):361-8. doi: 10.1055/s-0030-1262615. Epub 2010 Nov 16. German.
Background: PubMed 20719340Nickel JC, Tripp DA, Pontari M, Moldwin R, Mayer R, Carr LK, Doggweiler R, Yang CC, Mishra N, Nordling J. Interstitial cystitis/painful bladder syndrome and associated medical conditions with an emphasis on irritable bowel syndrome, fibromyalgia and chronic fatigue syndrome. J Urol. 2010 Oct;184(4):1358-63. doi: 10.1016/j.juro.2010.06.005. Epub 2010 Aug 17.
Background: PubMed 26010952Efrati S, Golan H, Bechor Y, Faran Y, Daphna-Tekoah S, Sekler G, Fishlev G, Ablin JN, Bergan J, Volkov O, Friedman M, Ben-Jacob E, Buskila D. Hyperbaric oxygen therapy can diminish fibromyalgia syndrome--prospective clinical trial. PLoS One. 2015 May 26;10(5):e0127012. doi: 10.1371/journal.pone.0127012. eCollection 2015.
Background: PubMed 21531887Arnold LM, Clauw DJ, McCarberg BH; FibroCollaborative. Improving the recognition and diagnosis of fibromyalgia. Mayo Clin Proc. 2011 May;86(5):457-64. doi: 10.4065/mcp.2010.0738.
Background: PubMed 15174219Yildiz S, Kiralp MZ, Akin A, Keskin I, Ay H, Dursun H, Cimsit M. A new treatment modality for fibromyalgia syndrome: hyperbaric oxygen therapy. J Int Med Res. 2004 May-Jun;32(3):263-7. doi: 10.1177/147323000403200305.
Background: PubMed 17900797van de Merwe JP, Nordling J, Bouchelouche P, Bouchelouche K, Cervigni M, Daha LK, Elneil S, Fall M, Hohlbrugger G, Irwin P, Mortensen S, van Ophoven A, Osborne JL, Peeker R, Richter B, Riedl C, Sairanen J, Tinzl M, Wyndaele JJ. Diagnostic criteria, classification, and nomenclature for painful bladder syndrome/interstitial cystitis: an ESSIC proposal. Eur Urol. 2008 Jan;53(1):60-7. doi: 10.1016/j.eururo.2007.09.019. Epub 2007 Sep 20.
Background: PubMed 17707887Brewer ME, White WM, Klein FA, Klein LM, Waters WB. Validity of Pelvic Pain, Urgency, and Frequency questionnaire in patients with interstitial cystitis/painful bladder syndrome. Urology. 2007 Oct;70(4):646-9. doi: 10.1016/j.urology.2007.06.1089. Epub 2007 Aug 20.
Individual participant dataSharing planned: Yes. We are planning wide distribution of these results among urologists, neurologists, and internal medicine specialists.

Related trials for Fibromyalgia

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
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Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gerardo Bosco, MD study director

University of Padova

Questions about this trial

What is this clinical trial studying?

A study testing Intermittent Exposure to Oxygen via Oro-Nasal Mask in people with Fibromyalgia and Interstitial Cystitis, run by University of South Florida.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Urination (time frame: 1-3 months after completing procedure). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03693001, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.