DMSO Efficacy in IC/PBS Patients During and After Treatment

Cystitis, Interstitial Clinical Trial

Official title:

Efficacy of DMSO Cocktail Treatment in Interstitial Cystitis Patients During and After Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01074567
• Other study ID #: 174/09
• Status: Recruiting
• Phase: N/A
• First received: February 23, 2010
• Last updated: April 4, 2011
• Start date: December 2009
• Est. completion date: December 2012

Study information

• Verified date: March 2010
• Source: Assaf-Harofeh Medical Center
• Contact: Kobi Stav, MD
• Phone: +972-8-9779400
• Email: stavkobi[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystitis
• Cystitis, Interstitial

Intervention

Drug:
• DMSO cocktail
intra-vesical: DMSO 50% in 50 cc water for injection 10 cc heparin 5000 IU hydrocortisone 100 mg bupivacaine 0.125%

Locations

Country	Name	City	State
Israel	Assaf Harofe Medical Center	Zeriffin

Sponsors (1)

Lead Sponsor	Collaborator
Assaf-Harofeh Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	urination diary		before treatment, at 3, 6, 9 and 12 treatments, 6 weeks, 3, 6, 12 month after last treatment	No

External Links

•   international painful bladder foundation
•   interstitial cystitis association