A Trial of Intravesical Therapy for Interstitial Cystitis in Patients With Generalized Vulvodynia

• Status: Withdrawn
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Scripps Health
• Treatments: Heparin; Lidocaine

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).