Comparative Study Between Hyperbaric Therapy and Intravesical Dimethyl Sulfoxide Instillation for Interstitial Cystitis
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Interstitial Cystitis |
Other: Hyperbaric Oxygen Therapy Drug: DMSO |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison Between Hyperbaric Oxygen Therapy (HBOT) and Intravesical Dimethyl Sulfoxide (DMSO) Instillation for the Treatment of Interstitial Cystitis - a Prospective, Randomized Cross-over Trial |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Intravesical DMSO instillation
50 mls of 50% DMSO instilled once a week to the urinary bladder for 12 consecutive weeks.
|
Drug: DMSO
50 mls of 50% DMSO instilled once a week to the urinary bladder for 12 consecutive weeks.
Other Name: dimethyl sulfoxide
|
|
Experimental: 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.
|
Other: Hyperbaric Oxygen Therapy
60 treatments (12 weeks - 5 days a week) of hyperbaric (pressure of 2 atmospheres) with 100% oxygen inhalation.
Other Names:
|
Detailed Description:
Interstitial cystitis / painful bladder syndrome (IC/PBS) presents as a pelvic pain condition associated with urinary urgency and frequency. These symptoms impair significantly the patient's quality of life. The etiology is yet not obvious. The current acceptable theory is injury or dysfunction of the Mucus (Glycosaminoglycans) layer that covers the inner surface of the urinary bladder. Abnormal diffusion of toxins from the urine to the walls of the bladder leads to inflammation, pain and scarring.
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Kobi Stav, MD | +972-89779400 | stavkobi@yahoo.com.au |
| Contact: Shay Efrati, MD | +972-577346364 | efratishai@013.net |
| Israel | |
| Assaf Harofe Medical Center | Recruiting |
| Zeriffin, Israel, 70300 | |
| Contact: Kobi Stav, MD +972-577346778 stavkobi@yahoo.com.au | |
| Contact: Shay Efrati, MD +972-577346364 efratishai@013.net | |
| Principal Investigator: | Kobi Stav, MD | Assaf Harofe Medical Center |
More Information
Additional Information:
Publications:
| Responsible Party: | Kobi Stav, Assaf-Harofeh Medical Center |
| ClinicalTrials.gov Identifier: | NCT01069263 History of Changes |
| Other Study ID Numbers: | 04/10 |
| Study First Received: | January 10, 2010 |
| Last Updated: | April 4, 2011 |
| Health Authority: | Israel: Ethics Commission |
Keywords provided by Assaf-Harofeh Medical Center:
|
Interstitial cystitis Painful bladder syndrome Chronic pelvic pain DMSO Hyperbaric oxygen therapy |
Additional relevant MeSH terms:
|
Cystitis Cystitis, Interstitial Urinary Bladder Diseases Urologic Diseases Dimethyl Sulfoxide Free Radical Scavengers |
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cryoprotective Agents Protective Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013