Comparative Study Between Hyperbaric Therapy and Intravesical Dimethyl Sulfoxide Instillation for Interstitial Cystitis
Comparison Between Hyperbaric Oxygen Therapy (HBOT) and Intravesical Dimethyl Sulfoxide (DMSO) Instillation for the Treatment of Interstitial Cystitis - a Prospective, Randomized Cross-over Trial
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to compare the efficacy of hyperbaric oxygen therapy (HBOT) to intravesical Dimethyl Sulfoxide (DMSO) instillation for the treatment of patients who suffers from Interstitial Cystitis / Painful bladder syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2010
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedApril 5, 2011
February 1, 2010
5.1 years
January 10, 2010
April 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjective improvement will be assessed by several questionnaires: the Oleary Sant symptom index score, bladder diary, 1-10 visual analogue scale for pain, PSQ4 questionnaire
1-4 weeks post treatment
Secondary Outcomes (1)
Objective improvement will be assessed by urodynamic test. The following parameters will be addressed: cystometric capacity, 1st sensation, normal sensation
1-4 weeks post treatment
Study Arms (2)
Intravesical DMSO instillation
ACTIVE COMPARATOR50 mls of 50% DMSO instilled once a week to the urinary bladder for 12 consecutive weeks.
Hyperbaric Oxygen Therapy (HBOT)
EXPERIMENTALOverall 60 treatments (5 days per weeks for 12 weeks). 90 minutes every session. Pressure of 2 atm. Inhalation of 100% oxygen.
Interventions
60 treatments (12 weeks - 5 days a week) of hyperbaric (pressure of 2 atmospheres) with 100% oxygen inhalation.
50 mls of 50% DMSO instilled once a week to the urinary bladder for 12 consecutive weeks.
Eligibility Criteria
You may qualify if:
- NIDDK diagnosis of interstitial cystitis
You may not qualify if:
- Previous treatment of hyperbaric therapy
- Contraindication for hyperbaric therapy (mid-ear pathology, abnormal chest X-ray, Claustrophobia, pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assaf Harofe Medical Center
Zeriffin, 70300, Israel
Related Publications (2)
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.
PMID: 3288775BACKGROUNDvan 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.
PMID: 15183555RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kobi Stav, MD
Assaf Harofe Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
January 10, 2010
First Posted
February 17, 2010
Study Start
February 1, 2010
Primary Completion
March 1, 2015
Study Completion
July 1, 2015
Last Updated
April 5, 2011
Record last verified: 2010-02