DMSO Efficacy in IC/PBS Patients During and After Treatment

NCT ID: NCT01074567

Last Updated: 2011-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Cystitis, Interstitial

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DMSO cocktail

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

Group Type EXPERIMENTAL

DMSO cocktail

Intervention Type DRUG

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

Interventions

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DMSO cocktail

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

Intervention Type DRUG

Other Intervention Names

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Dimethyl sulfoxide

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Assaf-Harofeh Medical Center

Principal Investigators

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Kobi Stav, MD

Role: PRINCIPAL_INVESTIGATOR

Assaf-Harofe MC

Locations

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Assaf Harofe Medical Center

Zeriffin, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Kobi Stav, MD

Role: CONTACT

+972-8-9779400

Miki Haifler, MD

Role: CONTACT

+972-8-9401

Facility Contacts

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Kobi Stav, MD

Role: primary

+972-577346778

Miki Haifler, MD

Role: backup

+972-523271255

Related Links

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

international painful bladder foundation

http://www.ichelp.org

interstitial cystitis association

Other Identifiers

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174/09

Identifier Type: -

Identifier Source: org_study_id

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