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

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ClinicalTrials.gov Identifier: NCT01048177
Recruitment Status : Withdrawn
First Posted : January 13, 2010
Last Update Posted : May 13, 2014
Information provided by (Responsible Party):
Bruce Kahn, Scripps Health

Brief Summary:
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 or disease Intervention/treatment Phase
Vulvodynia Drug: Bladder instillation with heparin/ lidocaine Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial of Intravesical Therapy for Interstitial Cystitis in Patients With Generalized Vulvodynia
Study Start Date : December 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Treatment Drug: Bladder instillation with heparin/ lidocaine
9 bladder instillations in 6 weeks

Primary Outcome Measures :
  1. Reduction in pelvic pain / vulvodynia [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01048177

United States, California
Scripps Clinic
San Diego, California, United States, 92130
Sponsors and Collaborators
Scripps Health
Principal Investigator: Bruce Kahn, M.D. Scripps Clinic

Responsible Party: Bruce Kahn, MD, Scripps Health
ClinicalTrials.gov Identifier: NCT01048177     History of Changes
Other Study ID Numbers: IRB-09-5381
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: May 13, 2014
Last Verified: May 2014

Keywords provided by Bruce Kahn, Scripps Health:
interstitial cystitis
pelvic pain

Additional relevant MeSH terms:
Cystitis, Interstitial
Urinary Bladder Diseases
Urologic Diseases
Vulvar Diseases
Genital Diseases, Female
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents