DMSO Efficacy in IC/PBS Patients During and After Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Assaf-Harofeh Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01074567
First received: February 23, 2010
Last updated: April 4, 2011
Last verified: March 2010
  Purpose

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 Intervention
Cystitis, Interstitial
Drug: DMSO cocktail

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of DMSO Cocktail Treatment in Interstitial Cystitis Patients During and After Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • urination diary [ Time Frame: before treatment, at 3, 6, 9 and 12 treatments, 6 weeks, 3, 6, 12 month after last treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
No publications provided

Responsible Party: Miki Haifler, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01074567     History of Changes
Other Study ID Numbers: 174/09
Study First Received: February 23, 2010
Last Updated: April 4, 2011
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Cystitis
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Dimethyl Sulfoxide
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014