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DMSO Efficacy in IC/PBS Patients During and After Treatment
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 March 2010 by Assaf-Harofeh Medical Center.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Assaf-Harofeh Medical Center
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
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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:
MedlinePlus related topics:
Interstitial Cystitis
Drug Information available for:
Dimethyl sulfoxide
U.S. FDA Resources
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 ]
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 ]
| 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 (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
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
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:
| 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 |
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 |
ClinicalTrials.gov processed this record on June 23, 2017