Back to resultsHBOT for Patients With IC/FM (Interstitial Cystitis/Fibromyalgia) (IC/FMHBOT)
Primary Purpose
Fibromyalgia, Interstitial Cystitis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intermittent Exposure to Oxygen via Oro-Nasal Mask
Sponsored by
About this trial
This is an interventional screening trial for Fibromyalgia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IC/FM Patients
Arm Description
All patients had been diagnosed with fibromyalgia and were suffering from IC by standard criteria.
Outcomes
Primary Outcome Measures
Frequency of Urination
Frequency of Urination was measured via a voiding diary. Patients recorded all urinary events via the voiding diary.
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).
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03693001
First Posted
September 28, 2018
Last Updated
December 7, 2020
Sponsor
University of South Florida
Collaborators
University of Padova
1. Study Identification
Unique Protocol Identification Number
NCT03693001
Brief Title
HBOT for Patients With IC/FM (Interstitial Cystitis/Fibromyalgia)
Acronym
IC/FMHBOT
Official Title
Clinical and Morphological Effects of Hyperbaric Oxygen Therapy in Patients With Interstitial Cystitis Associated With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
June 1, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
University of Padova
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Interstitial Cystitis
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IC/FM Patients
Arm Type
Experimental
Arm Description
All patients had been diagnosed with fibromyalgia and were suffering from IC by standard criteria.
Intervention Type
Device
Intervention Name(s)
Intermittent Exposure to Oxygen via Oro-Nasal Mask
Intervention Description
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 Measure Information:
Title
Frequency of Urination
Description
Frequency of Urination was measured via a voiding diary. Patients recorded all urinary events via the voiding diary.
Time Frame
1-3 months after completing procedure
Title
Pain symptoms in IC patients
Description
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).
Time Frame
1-3 months after completing procedure
Title
Pain Symptoms in IC patients
Description
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.
Time Frame
1-3 months after completing procedure
Title
Bladder Capacity (as part of symptoms)
Description
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.
Time Frame
1-3 months after completing procedure
Title
Bladder Capacity
Description
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.
Time Frame
1-3 months after completing procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerardo Bosco, MD
Organizational Affiliation
University of Padova
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
12385909
Citation
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.
Results Reference
background
PubMed Identifier
21609485
Citation
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.
Results Reference
background
PubMed Identifier
15183555
Citation
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.
Results Reference
background
PubMed Identifier
21813166
Citation
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.
Results Reference
background
PubMed Identifier
21874665
Citation
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.
Results Reference
background
PubMed Identifier
21082515
Citation
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.
Results Reference
background
PubMed Identifier
20719340
Citation
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.
Results Reference
background
PubMed Identifier
26010952
Citation
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.
Results Reference
background
PubMed Identifier
21531887
Citation
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.
Results Reference
background
PubMed Identifier
15174219
Citation
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.
Results Reference
background
PubMed Identifier
17900797
Citation
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.
Results Reference
background
PubMed Identifier
17707887
Citation
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.
Results Reference
background
PubMed Identifier
26259883
Citation
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.
Results Reference
background
PubMed Identifier
11378052
Citation
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.
Results Reference
background
PubMed Identifier
14641410
Citation
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.
Results Reference
background
PubMed Identifier
15311005
Citation
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.
Results Reference
background
PubMed Identifier
31690286
Citation
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.
Results Reference
derived
Learn more about this trial
HBOT for Patients With IC/FM (Interstitial Cystitis/Fibromyalgia)
We'll reach out to this number within 24 hrs