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DMSO Efficacy in IC/PBS Patients During and After Treatment

Primary Purpose

Cystitis, Interstitial

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

DMSO cocktail

About this trial

This is an interventional treatment trial for Cystitis, Interstitial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Assaf Harofe Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DMSO cocktail

Arm Description

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

Outcomes

Primary Outcome Measures

O'leary-Sant interstitial cystitis symptom and problem questionaire

Secondary Outcome Measures

urination diary

Full Information

NCT ID

NCT01074567

First Posted

February 23, 2010

Last Updated

April 4, 2011

Sponsor

Assaf-Harofeh Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01074567

Brief Title

DMSO Efficacy in IC/PBS Patients During and After Treatment

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Unknown status

Study Start Date

December 2009 (undefined)

Primary Completion Date

December 2011 (Anticipated)

Study Completion Date

December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystitis, Interstitial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DMSO cocktail

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

DMSO cocktail

Other Intervention Name(s)

Dimethyl sulfoxide

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

urination diary

Time Frame

before treatment, at 3, 6, 9 and 12 treatments, 6 weeks, 3, 6, 12 month after last treatment

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kobi Stav, MD

Phone

+972-8-9779400

stavkobi@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Miki Haifler, MD

Phone

+972-8-9401

mikihaifler@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kobi Stav, MD

Organizational Affiliation

Assaf-Harofe MC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Assaf Harofe Medical Center

City

Zeriffin

ZIP/Postal Code

70300

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kobi Stav, MD

Phone

+972-577346778

stavkobi@yahoo.com.au

First Name & Middle Initial & Last Name & Degree

Miki Haifler, MD

Phone

+972-523271255

mikihaifler@gmail.com

12. IPD Sharing Statement

Links:

URL

http://www.painful-bladder.org/index.html

Description

international painful bladder foundation

URL

http://www.ichelp.org

Description

interstitial cystitis association

Learn more about this trial

DMSO Efficacy in IC/PBS Patients During and After Treatment

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