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Comparative Study Between Hyperbaric Therapy and Intravesical Dimethyl Sulfoxide Instillation for Interstitial Cystitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01069263
First Posted: February 17, 2010
Last Update Posted: April 5, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assaf-Harofeh Medical Center
  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
Intervention Model: Crossover Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

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:
  • HBOT
  • Hyperbaric chamber
  • Hyperbaric therapy

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069263


Contacts
Contact: Kobi Stav, MD +972-89779400 stavkobi@yahoo.com.au
Contact: Shay Efrati, MD +972-577346364 efratishai@013.net

Locations
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   
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
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
First Submitted: January 10, 2010
First Posted: February 17, 2010
Last Update Posted: April 5, 2011
Last Verified: February 2010

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
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action