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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Bruce Kahn, Scripps Health
ClinicalTrials.gov Identifier:
NCT01048177
First received: January 11, 2010
Last updated: May 12, 2014
Last verified: May 2014
  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 2

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:


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 ]

Enrollment: 0
Study Start Date: December 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Drug: Bladder instillation with heparin/ lidocaine
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Scripps Clinic
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, MD, Scripps Health
ClinicalTrials.gov Identifier: NCT01048177     History of Changes
Other Study ID Numbers: IRB-09-5381
Study First Received: January 11, 2010
Last Updated: May 12, 2014
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 July 22, 2014