DMSO Efficacy in IC/PBS Patients During and After Treatment
Recruitment status was Recruiting
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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 |
- 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 ]
- 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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: 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 |
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, Interstitial Cystitis Urinary Bladder Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on February 27, 2015