- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03693001
HBOT for Patients With IC/FM (Interstitial Cystitis/Fibromyalgia) (IC/FMHBOT)
December 7, 2020 updated by: University of South Florida
Clinical and Morphological Effects of Hyperbaric Oxygen Therapy in Patients With Interstitial Cystitis Associated With 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: IC/FM Patients
All patients had been diagnosed with fibromyalgia and were suffering from IC by standard criteria.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1-3 months after completing procedure
|
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).
|
1-3 months after completing procedure
|
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.
|
1-3 months after completing procedure
|
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.
|
1-3 months after completing procedure
|
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.
|
1-3 months after completing procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Gerardo Bosco, MD, University of Padova
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Tamaki M, Saito R, Ogawa O, Yoshimura N, Ueda T. Possible mechanisms inducing glomerulations in interstitial cystitis: relationship between endoscopic findings and expression of angiogenic growth factors. J Urol. 2004 Sep;172(3):945-8. doi: 10.1097/01.ju.0000135009.55905.cb.
- Bosco G, Ostardo E, Rizzato A, Garetto G, Paganini M, Melloni G, Giron G, Pietrosanti L, Martinelli I, Camporesi E. Clinical and morphological effects of hyperbaric oxygen therapy in patients with interstitial cystitis associated with fibromyalgia. BMC Urol. 2019 Nov 5;19(1):108. doi: 10.1186/s12894-019-0545-6.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Actual)
June 1, 2018
Study Completion (Actual)
June 15, 2018
Study Registration Dates
First Submitted
September 28, 2018
First Submitted That Met QC Criteria
October 1, 2018
First Posted (Actual)
October 2, 2018
Study Record Updates
Last Update Posted (Actual)
December 9, 2020
Last Update Submitted That Met QC Criteria
December 7, 2020
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HEC-DSB 07/16 Padua, It
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
We are planning wide distribution of these results among urologists, neurologists, and internal medicine specialists.
IPD Sharing Time Frame
6 months
IPD Sharing Access Criteria
upon email request.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fibromyalgia
-
University of AberdeenCompletedFibromyalgia | Fibromyalgia, Primary | Fibromyalgia, SecondaryUnited Kingdom
-
Eli Lilly and CompanyCompletedFibromyalgia, Primary | Fibromyalgia, SecondaryMexico
-
Rasmia ElgoharyNot yet recruiting
-
Spaulding Rehabilitation HospitalNot yet recruiting
-
Cairo UniversityNot yet recruiting
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Completed
-
University of UtahTerminated
-
State University of New York - Upstate Medical...CompletedFibromyalgia, PrimaryUnited States
-
University of Sao Paulo General HospitalFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
Tel-Aviv Sourasky Medical CenterCompletedFibromyalgia (FM)Israel
Clinical Trials on Intermittent Exposure to Oxygen via Oro-Nasal Mask
-
Washington University School of MedicineBarnes-Jewish HospitalCompletedSurgical Wound Infection | Endometritis | Infection; Cesarean SectionUnited States
-
Vanderbilt University Medical CenterRevolutionary Medical Devices, Inc.CompletedVentilation | Colonoscopy | OxygenationUnited States
-
Laval UniversityUnknown
-
Dr. David Yuen Chung CHANRecruitingChronic Subdural HematomaHong Kong
-
University of California, Los AngelesAerogenRecruitingAirway Obstruction | Hypoxemic Respiratory FailureUnited States
-
University of VirginiaONY; LMA North AmericaTerminatedRespiratory Distress Syndrome, NewbornUnited States
-
Erzincan Military HospitalUnknownPostpartum HemorrhageTurkey