Comparative Study Between Hyperbaric Therapy and Intravesical Dimethyl Sulfoxide Instillation for Interstitial Cystitis
NCT ID: NCT01069263
Last Updated: 2011-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2010-02-28
2015-07-31
Brief Summary
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Detailed Description
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Many types of treatments were described but most of them were not evaluated in well designed randomized controlled studies. For now, there is no one single treatment that gives good outcome to every patient. Therefore, the treatment of patients with IC/PBS is challenging. In this study, we will compare the efficacy of hyperbaric oxygen therapy (HBOT) to intravesical dimethyl sulfoxide (DMSO) instillation for the treatment of patients who suffers from IC/PBS.
Patients with IC (NIDDK criteria) will be randomized to have either DMSO instillation or HBOT.
Before and after treatments the patients will fill out questionnaires (O'Leary-Sant Interstitial Cystitis Symptom and Problem Index), visual analogue scale for pain and bladder diaries. In addition, urodynamics will be performed before and after treatments. In case of incomplete symptoms remission, patients will be crossed over to have the other treatment.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Intravesical DMSO instillation
50 mls of 50% DMSO instilled once a week to the urinary bladder for 12 consecutive weeks.
DMSO
50 mls of 50% DMSO instilled once a week to the urinary bladder for 12 consecutive weeks.
Hyperbaric Oxygen Therapy (HBOT)
Overall 60 treatments (5 days per weeks for 12 weeks). 90 minutes every session. Pressure of 2 atm. Inhalation of 100% oxygen.
Hyperbaric Oxygen Therapy
60 treatments (12 weeks - 5 days a week) of hyperbaric (pressure of 2 atmospheres) with 100% oxygen inhalation.
Interventions
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Hyperbaric Oxygen Therapy
60 treatments (12 weeks - 5 days a week) of hyperbaric (pressure of 2 atmospheres) with 100% oxygen inhalation.
DMSO
50 mls of 50% DMSO instilled once a week to the urinary bladder for 12 consecutive weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Contraindication for hyperbaric therapy (mid-ear pathology, abnormal chest X-ray, Claustrophobia, pregnancy
18 Years
85 Years
ALL
No
Sponsors
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Assaf-Harofeh Medical Center
OTHER_GOV
Responsible Party
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Assaf-Harofeh Medical Center
Principal Investigators
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Kobi Stav, MD
Role: PRINCIPAL_INVESTIGATOR
Assaf Harofe Medical Center
Locations
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Assaf Harofe Medical Center
Zeriffin, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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Perez-Marrero R, Emerson LE, Feltis JT. A controlled study of dimethyl sulfoxide in interstitial cystitis. J Urol. 1988 Jul;140(1):36-9. doi: 10.1016/s0022-5347(17)41478-9.
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.
Related Links
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International Painful Bladder Foundation
Interstitial Cystitis Association
Other Identifiers
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04/10
Identifier Type: -
Identifier Source: org_study_id
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