A Trial of Intravesical Therapy for Interstitial Cystitis in Patients With Generalized Vulvodynia - Full Text View

A Trial of Intravesical Therapy for Interstitial Cystitis in Patients With Generalized Vulvodynia (VV/IC)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2010 by Scripps Health. Recruitment status was Recruiting

First Received on January 11, 2010. Last Updated on January 12, 2010 History of Changes

Sponsor:	Scripps Health
Information provided by:	Scripps Health
ClinicalTrials.gov Identifier:	NCT01048177

Purpose

In order to investigate whether the pain in women with vulvodynia may represent bladder origin pain, we will be performing a diagnostic test for interstitial cystitis (IC) in women with generalized vulvodynia. Those women with a positive test for IC, we will be performing a series of bladder treatments (instillations) for IC and checking symptoms throughout the trial to see if significant relief of vulvar pain can be obtained through treatment for IC.

Condition	Intervention	Phase
Vulvodynia	Drug: Bladder instillation with heparin/ lidocaine	Phase II

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Trial of Intravesical Therapy for Interstitial Cystitis in Patients With Generalized Vulvodynia

Resource links provided by NLM:

MedlinePlus related topics: Interstitial Cystitis Pelvic Pain

Drug Information available for: Lidocaine Heparin

U.S. FDA Resources

Further study details as provided by Scripps Health:

Primary Outcome Measures:

Reduction in pelvic pain / vulvodynia [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	January 2010
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Intervention Details:

9 bladder instillations in 6 weeks

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

We plan to enroll women 18 years or older with GV and negative tests for urine infection, negative cultures for Chlamydia and gonorrhea when indicated, and negative screens or cultures for yeast infection or bacterial vaginosis when indicated.
Patient symptoms will need to include no or minimal vaginal discharge.
Patients will have a minimum Visual Analog Score for vulvar pain of at least 3/10.
In order to receive bladder instillations, patients will need to have a positive potassium sensitivity test.

Exclusion Criteria:

We will exclude patients from enrollment if they use chronic narcotic pain medication or have localized vulvodynia. (We believe that localize vulvodynia is less likely of bladder origin).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01048177

Contacts

Contact: Bruce Kahn, M.D.	858-764-9080	kahn.bruce@scrippshealth.org
Contact: Nancy Giovanetty	858-764-9080	giovanetty.nancy@scrippshealth.org

Locations

United States, California
Scripps Clinic	Recruiting
San Diego, California, United States, 92130

Sponsors and Collaborators

Scripps Health

Investigators

Principal Investigator:

Bruce Kahn, M.D.

Scripps Clinic

More Information

No publications provided

Responsible Party:	Bruce Kahn, M.D., Scripps Clinic Medical groupe, San diego, CA, Scripps Clinic
ClinicalTrials.gov Identifier:	NCT01048177 History of Changes
Other Study ID Numbers:	IRB-09-5381
Study First Received:	January 11, 2010
Last Updated:	January 12, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Scripps Health:

vulvodynia
interstitial cystitis
pelvic pain

Additional relevant MeSH terms:

Cystitis
Cystitis, Interstitial
Vulvodynia
Urinary Bladder Diseases
Urologic Diseases
Vulvar Diseases
Genital Diseases, Female
Lidocaine
Anesthetics, Local
Anesthetics

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012