NCT01074567

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 5, 2011

Status Verified

March 1, 2010

Enrollment Period

2 years

First QC Date

February 23, 2010

Last Update Submit

April 4, 2011

Conditions

Cystitis, Interstitial

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • urination diary

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

Study Arms (1)

DMSO cocktail

EXPERIMENTAL

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

Drug: DMSO cocktail

Interventions

DMSO cocktailDRUG

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

Also known as: Dimethyl sulfoxide
DMSO cocktail

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with IC according to International Continence Society:
  • more than 6 month of pelvic pain
  • urinary frequency, urgency, dyspareunia

You may not qualify if:

  • genitourinary tract infection
  • known genitourinary malformation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofe Medical Center

Zeriffin, 70300, Israel

RECRUITING

Related Links

MeSH Terms

Conditions

Cystitis, Interstitial

Interventions

Dimethyl Sulfoxide

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

SulfoxidesSulfur CompoundsOrganic Chemicals

Study Officials

  • Kobi Stav, MD

    Assaf-Harofe MC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kobi Stav, MD

CONTACT

+972-8-9779400stavkobi@gmail.com

Miki Haifler, MD

CONTACT

+972-8-9401mikihaifler@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

February 23, 2010

First Posted

February 24, 2010

Study Start

December 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

April 5, 2011

Record last verified: 2010-03

Locations

IL(1)