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DMSO Efficacy in IC/PBS Patients During and After Treatment

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ClinicalTrials.gov Identifier: NCT01074567
Recruitment Status : Unknown
Verified March 2010 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : February 24, 2010
Last Update Posted : April 5, 2011
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center

Study Description
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Brief Summary:
The purpose of this study is to examine the efficacy of dimethylsulphoxide (DMSO) cocktail in patients with interstitial cystitis during the treatment period (12 weeks) and after it (at 6 weeks, 3, 6 and 12 month).

Condition or disease Intervention/treatment Phase
Cystitis, Interstitial Drug: DMSO cocktail Not Applicable

Detailed Description:

The modern treatment of IC is a multi-modal treatment which includes behavioural treatment, physiotherapy of the pelvic floor musculature, oral medication (e.g. Amitryptiline) and intra-vesical instillation (e.g. DMSO, steroids, heparin). These treatments were found to be effective in a number of studies and are approved by the FDA. However, the optimal duration of intra-vesical instilation is not known.

All patients with IC (according to the international continence society criteria) will receive 12 weekly intra-vesical instillation of DMSO. All patients will fill an O'leary-Sant questionaire and a urination diary before treatment, after 3, 6, 9 and 12 treatments and at 6 weeks, 3, 6 and 12 month after the end to the treatment.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of DMSO Cocktail Treatment in Interstitial Cystitis Patients During and After Treatment
Study Start Date : December 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: DMSO cocktail
intra-vesical: DMSO 50% in 50 cc water for injection 10 cc heparin 5000 IU hydrocortisone 100 mg bupivacaine 0.125%
 Drug: DMSO cocktail
intra-vesical: DMSO 50% in 50 cc water for injection 10 cc heparin 5000 IU hydrocortisone 100 mg bupivacaine 0.125%
Other Name: Dimethyl sulfoxide


Outcome Measures
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Primary Outcome Measures :
  1. O'leary-Sant interstitial cystitis symptom and problem questionaire [ Time Frame: before treatment, at 3, 6, 9 and 12 treatments, 6 weeks, 3, 6, 12 month after last treatment ]

Secondary Outcome Measures :
  1. urination diary [ Time Frame: before treatment, at 3, 6, 9 and 12 treatments, 6 weeks, 3, 6, 12 month after last treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with IC according to International Continence Society:

    • more than 6 month of pelvic pain
    • urinary frequency, urgency, dyspareunia

Exclusion Criteria:

  • genitourinary tract infection
  • known genitourinary malformation
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01074567


Contacts
Contact: Kobi Stav, MD +972-8-9779400 stavkobi@gmail.com
Contact: Miki Haifler, MD +972-8-9401 mikihaifler@gmail.com

Locations
Israel
Assaf Harofe Medical Center Recruiting
Zeriffin, Israel, 70300
Contact: Kobi Stav, MD    +972-577346778    stavkobi@yahoo.com.au   
Contact: Miki Haifler, MD    +972-523271255    mikihaifler@gmail.com   
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Kobi Stav, MD Assaf-Harofe MC
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
international painful bladder foundation  This link exits the ClinicalTrials.gov site
interstitial cystitis association  This link exits the ClinicalTrials.gov site

Responsible Party: Miki Haifler, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01074567     History of Changes
Other Study ID Numbers: 174/09
First Posted: February 24, 2010    Key Record Dates
Last Update Posted: April 5, 2011
Last Verified: March 2010

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