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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01069263 |
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Date of registration:
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10/01/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparative Study Between Hyperbaric Therapy and Intravesical Dimethyl Sulfoxide Instillation for Interstitial Cystitis
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Scientific title:
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Comparison Between Hyperbaric Oxygen Therapy (HBOT) and Intravesical Dimethyl Sulfoxide (DMSO) Instillation for the Treatment of Interstitial Cystitis - a Prospective, Randomized Cross-over Trial |
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Date of first enrolment:
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February 2010 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01069263 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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Kobi Stav, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assaf Harofe Medical Center |
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Name:
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Kobi Stav, MD |
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Address:
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Telephone:
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+972-577346778 |
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Email:
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stavkobi@yahoo.com.au |
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Affiliation:
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Name:
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Kobi Stav, MD |
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Address:
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Telephone:
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+972-89779400 |
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Email:
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stavkobi@yahoo.com.au |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- NIDDK diagnosis of interstitial cystitis
Exclusion Criteria:
- Previous treatment of hyperbaric therapy
- Contraindication for hyperbaric therapy (mid-ear pathology, abnormal chest X-ray,
Claustrophobia, pregnancy
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Interstitial Cystitis
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Intervention(s)
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Drug: DMSO
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Other: Hyperbaric Oxygen Therapy
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Primary Outcome(s)
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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
[Time Frame: 1-4 weeks post treatment]
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Secondary Outcome(s)
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Objective improvement will be assessed by urodynamic test. The following parameters will be addressed: cystometric capacity, 1st sensation, normal sensation
[Time Frame: 1-4 weeks post treatment]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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