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

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%
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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
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- 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 ]
- urination diary [ Time Frame: before treatment, at 3, 6, 9 and 12 treatments, 6 weeks, 3, 6, 12 month after last treatment ]

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

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
Contact: Kobi Stav, MD | +972-8-9779400 | stavkobi@gmail.com | |
Contact: Miki Haifler, MD | +972-8-9401 | mikihaifler@gmail.com |
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 |
Principal Investigator: | Kobi Stav, MD | Assaf-Harofe MC |
Additional Information:
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 |