Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMSO cocktail | Experimental | intra-vesical: DMSO 50% in 50 cc water for injection 10 cc heparin 5000 IU hydrocortisone 100 mg bupivacaine 0.125% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMSO cocktail | Drug | intra-vesical: DMSO 50% in 50 cc water for injection 10 cc heparin 5000 IU hydrocortisone 100 mg bupivacaine 0.125% |
|
| Measure | Description | Time Frame |
|---|---|---|
| O'leary-Sant interstitial cystitis symptom and problem questionaire | before treatment, at 3, 6, 9 and 12 treatments, 6 weeks, 3, 6, 12 month after last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| urination diary | before treatment, at 3, 6, 9 and 12 treatments, 6 weeks, 3, 6, 12 month after last treatment |
Not provided
Inclusion Criteria:
patients with IC according to International Continence Society:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kobi Stav, MD | Contact | +972-8-9779400 | stavkobi@gmail.com | |
| Miki Haifler, MD | Contact | +972-8-9401 | mikihaifler@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kobi Stav, MD | Assaf-Harofe MC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf Harofe Medical Center | Recruiting | Zeriffin | 70300 | Israel |
Not provided
| Label | URL |
|---|---|
| international painful bladder foundation | View source |
| interstitial cystitis association | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D018856 | Cystitis, Interstitial |
| ID | Term |
|---|---|
| D003556 | Cystitis |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004121 | Dimethyl Sulfoxide |
| ID | Term |
|---|---|
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |