Clinical trial NCT03693001: HBOT for Patients With IC/FM (Interstitial Cystitis/Fibromyalgia)
Official title: Clinical and Morphological Effects of Hyperbaric Oxygen Therapy in Patients With Interstitial Cystitis Associated With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Interstitial Cystitis
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: University of Padova
First posted: 2018-10-02
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Frequency of Urination
timeFrame: 1-3 months after completing procedure
measure: Pain symptoms in IC patients
timeFrame: 1-3 months after completing procedure
measure: Pain Symptoms in IC patients
timeFrame: 1-3 months after completing procedure
measure: Bladder Capacity (as part of symptoms)
timeFrame: 1-3 months after completing procedure
measure: Bladder Capacity
timeFrame: 1-3 months after completing procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Padova
name: Gerardo Bosco, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.