|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
28 November 2022 |
|
Main ID: |
NCT01048177 |
|
Date of registration:
|
11/01/2010 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
A Trial of Intravesical Therapy for Interstitial Cystitis in Patients With Generalized Vulvodynia
VV/IC |
|
Scientific title:
|
A Trial of Intravesical Therapy for Interstitial Cystitis in Patients With Generalized Vulvodynia |
|
Date of first enrolment:
|
December 2012 |
|
Target sample size:
|
0 |
|
Recruitment status: |
Withdrawn |
|
URL:
|
https://clinicaltrials.gov/show/NCT01048177 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Bruce Kahn, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Scripps Clinic |
| | |
|
Key inclusion & exclusion 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).
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Vulvodynia
|
|
Intervention(s)
|
|
Drug: Bladder instillation with heparin/ lidocaine
|
|
Primary Outcome(s)
|
|
Reduction in pelvic pain / vulvodynia
[Time Frame: 16 weeks]
|
|
Secondary ID(s)
|
|
IRB-09-5381
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|